CompletedNCT04922216AGILEUpdated Jul 20, 2025Results posted

Adaptive Goals and Interventions for Lifestyle Enhancement

An interventional study of Core and Standard Diet Monitoring in Obesity, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2025-07-20.

Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 759
Allocation: Randomized
Ages: 18 Years to 39 Years
Sex: All

Study summary

Mobile obesity interventions have the potential to reach a diverse population in need; however, while effective, have not resulted in weight losses obtained in in-person interventions. Newer digital approaches called Just-in-Time Adaptive Interventions (JITAI) that offer adaptive, personalized feedback 'when needed' and in 'real time' offer an opportunity to use digital health tools "just in time". This study seeks to identify the optimal components of a comprehensive weight loss JITAI that results in weight losses that meet or exceed those in existing remotely delivered interventions.

Read the detailed description

Obesity has reached epidemic proportions in the United States and is recognized as a major cause of morbidity and mortality. Young adults (18-35 years) are at particularly high risk for weight gain and obesity. In-person behavioral interventions generally produce clinically significant weight losses; however, cost and access limit their potential to reduce obesity at a population level. Although web-based interventions that mimic the structure of weekly face-to-face treatment have proven a viable alternative treatment, weight losses are generally smaller than in-person treatment. Exclusively mobile treatments have been less effective, producing 1-3 kgs over 6 months. Newer digital intervention approaches called "Just-in-Time Adaptive Interventions" (JITAIs) promise to improve upon outcomes by offering adaptive, personalized feedback on behavior "when needed" in "real time," rather than on a fixed schedule. This "just-in-time," or JIT, approach is made possible by the emergence of low-cost and widely available digital health tools that allow for the collection of continually updated health data. However, few studies have used JIT approaches in remotely delivered, fully scalable weight loss interventions. Although JITAIs are a potentially transformative approach to delivering obesity interventions, a major obstacle in their development is efficient selection of components and systematic design of an optimized intervention package that produces clinically meaningful weight losses with a population-level strategy. To solve this problem, this trial will use the Multiphase Optimization Strategy (MOST), an engineering-inspired framework, and a highly efficient experimental design to identify which levels of 5 intervention components contribute meaningfully to change in weight over 6 months among young adults with overweight and obesity. All participants (n=608) will receive a core 6-month weight loss intervention that includes evidence-based lessons, behavioral skills training, and daily weighing. With the goal of determining if greater adaptation will lead to greater weight loss, participants will be randomized to standard versus more adaptive options of 5 additional intervention components: 1) diet monitoring approach (standard vs. simplified), 2) adaptive physical activity goals (weekly vs. daily), 3) decision points for message timing (fixed vs. adaptive), 4) decision rules for message content (standard vs. adaptive), and 5) message choice (no vs. yes). Candidate components have been carefully selected from empirical evidence, tested in prior studies conducted by the research team, or in a pilot micro-randomized trial conducted by the research team. Assessments will occur at 0, 3 and 6 months to accomplish the following specific aims: 1) Build an optimized JITAI consisting of the set of intervention components that yield the greatest improvement in weight change among young adults at 6 months; 2) Conduct mediation analyses to test the relationships between the intervention components and hypothesized proximal mediators (self-regulation, competence, relatedness, relevance, autonomy) and more distal behavioral mediators (dietary intake, physical activity, and daily self-weighting); and 3) Conduct exploratory analyses of program engagement.

Conditions studied

Obesity

Browse trials for

Obesity 6,296

Keywords

behavioral intervention
JITAI (just-in-time adaptive intervention)

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 759 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 39 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

body mass index (BMI) of 25-45 kg/m\^2
English-speaking and writing
own a smartphone with a data and text messaging plan
willing to be randomized to any levels of the factors

Exclusion criteria

Exclusion Criteria:

Type 1 diabetes or currently receiving medical treatment for Type 2 diabetes
Other health problems which may influence the ability to walk for physical activity or be associated with unintentional weight change, including cancer treatment within the past 5 years or tuberculosis
Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q; items 1-4)
Lost 10 or more pounds (and kept it off) in the last 6 months
Currently taking weight loss medications
Report a past diagnosis of or current treatment for a DSM-V (Diagnostic and Statistical Manual 5) eating disorder (anorexia nervosa or bulimia nervosa)
Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
Hospitalization for depression or other psychiatric disorder within the past 12 months
History of psychotic disorder or bipolar disorder
Another member of the household is a participant or staff member on this trial
Currently participating in a weight loss, nutrition or physical activity study or program or other study that would interfere with this study

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial assignment
Masking: Double (Investigator, Outcomes assessor)
Enrollment: 759 participants (actual)

Study arms

Experimental
Condition 1
Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Standard Content + No Choice
Behavioral: Core · Behavioral: Standard Diet Monitoring · Behavioral: Adaptive Activity Goals (Daily) · Behavioral: Message Decision Points (Fixed) · Behavioral: Message Decision Rules (Standard) · Behavioral: Message Choice (No)
Experimental
Condition 2
Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Standard Content + Choice
Behavioral: Core · Behavioral: Standard Diet Monitoring · Behavioral: Adaptive Activity Goals (Daily) · Behavioral: Message Decision Points (Fixed) · Behavioral: Message Decision Rules (Standard) · Behavioral: Message Choice (Yes)
Experimental
Condition 3
Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + No Choice
Behavioral: Core · Behavioral: Standard Diet Monitoring · Behavioral: Adaptive Activity Goals (Daily) · Behavioral: Message Decision Points (Fixed) · Behavioral: Message Decision Rules (Adaptive) · Behavioral: Message Choice (No)
Experimental
Condition 4
Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + Choice
Behavioral: Core · Behavioral: Standard Diet Monitoring · Behavioral: Adaptive Activity Goals (Daily) · Behavioral: Message Decision Points (Fixed) · Behavioral: Message Decision Rules (Adaptive) · Behavioral: Message Choice (Yes)
Experimental
Condition 5
Core+Standard Diet Monitoring+Daily Activity Goal+Adaptive Timing+Standard Content+No Choice
Behavioral: Core · Behavioral: Standard Diet Monitoring · Behavioral: Adaptive Activity Goals (Daily) · Behavioral: Message Decision Points (Adaptive) · Behavioral: Message Decision Rules (Standard) · Behavioral: Message Choice (No)
Experimental
Condition 6
Core + Standard Diet Monitoring + Daily Activity Goal + Adaptive Timing + Standard Content + Choice
Behavioral: Core · Behavioral: Standard Diet Monitoring · Behavioral: Adaptive Activity Goals (Daily) · Behavioral: Message Decision Points (Adaptive) · Behavioral: Message Decision Rules (Standard) · Behavioral: Message Choice (Yes)
Experimental
Condition 7
Core+ Standard Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice
Behavioral: Core · Behavioral: Standard Diet Monitoring · Behavioral: Adaptive Activity Goals (Daily) · Behavioral: Message Decision Points (Adaptive) · Behavioral: Message Decision Rules (Adaptive) · Behavioral: Message Choice (No)
Experimental
Condition 8
Core + Standard Diet Monitoring + Daily Activity Goal + Adaptive Timing + Adaptive Content + Choice
Behavioral: Core · Behavioral: Standard Diet Monitoring · Behavioral: Adaptive Activity Goals (Daily) · Behavioral: Message Decision Points (Adaptive) · Behavioral: Message Decision Rules (Adaptive) · Behavioral: Message Choice (Yes)
Experimental
Condition 9
Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + No Choice
Behavioral: Core · Behavioral: Standard Diet Monitoring · Behavioral: Adaptive Activity Goals (Weekly) · Behavioral: Message Decision Points (Fixed) · Behavioral: Message Decision Rules (Standard) · Behavioral: Message Choice (No)
Experimental
Condition 10
Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + Choice
Behavioral: Core · Behavioral: Standard Diet Monitoring · Behavioral: Adaptive Activity Goals (Weekly) · Behavioral: Message Decision Points (Fixed) · Behavioral: Message Decision Rules (Standard) · Behavioral: Message Choice (Yes)
Experimental
Condition 11
Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + No Choice
Behavioral: Core · Behavioral: Standard Diet Monitoring · Behavioral: Adaptive Activity Goals (Weekly) · Behavioral: Message Decision Points (Fixed) · Behavioral: Message Decision Rules (Adaptive) · Behavioral: Message Choice (No)
Experimental
Condition 12
Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + Choice
Behavioral: Core · Behavioral: Standard Diet Monitoring · Behavioral: Adaptive Activity Goals (Weekly) · Behavioral: Message Decision Points (Fixed) · Behavioral: Message Decision Rules (Adaptive) · Behavioral: Message Choice (Yes)
Experimental
Condition 13
Core+Standard Diet Monitoring+Weekly Activity Goal+Adaptive Timing+Standard Content+No Choice
Behavioral: Core · Behavioral: Standard Diet Monitoring · Behavioral: Adaptive Activity Goals (Weekly) · Behavioral: Message Decision Points (Adaptive) · Behavioral: Message Decision Rules (Standard) · Behavioral: Message Choice (No)
Experimental
Condition 14
Core + Standard Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Standard Content + Choice
Behavioral: Core · Behavioral: Standard Diet Monitoring · Behavioral: Adaptive Activity Goals (Weekly) · Behavioral: Message Decision Points (Adaptive) · Behavioral: Message Decision Rules (Standard) · Behavioral: Message Choice (Yes)
Experimental
Condition 15
Core + Standard Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice
Behavioral: Core · Behavioral: Standard Diet Monitoring · Behavioral: Adaptive Activity Goals (Weekly) · Behavioral: Message Decision Points (Adaptive) · Behavioral: Message Decision Rules (Adaptive) · Behavioral: Message Choice (No)
Experimental
Condition 16
Core + Standard Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Adaptive Content + Choice
Behavioral: Core · Behavioral: Standard Diet Monitoring · Behavioral: Adaptive Activity Goals (Weekly) · Behavioral: Message Decision Points (Adaptive) · Behavioral: Message Decision Rules (Adaptive) · Behavioral: Message Choice (Yes)
Experimental
Condition 17
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Standard Content+ No Choice
Behavioral: Core · Behavioral: Simplified Diet Monitoring · Behavioral: Adaptive Activity Goals (Daily) · Behavioral: Message Decision Points (Fixed) · Behavioral: Message Decision Rules (Standard) · Behavioral: Message Choice (No)
Experimental
Condition 18
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Standard Content+ Choice
Behavioral: Core · Behavioral: Simplified Diet Monitoring · Behavioral: Adaptive Activity Goals (Daily) · Behavioral: Message Decision Points (Fixed) · Behavioral: Message Decision Rules (Standard) · Behavioral: Message Choice (Yes)
Experimental
Condition 19
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Adaptive Content+ No Choice
Behavioral: Core · Behavioral: Simplified Diet Monitoring · Behavioral: Adaptive Activity Goals (Daily) · Behavioral: Message Decision Points (Fixed) · Behavioral: Message Decision Rules (Adaptive) · Behavioral: Message Choice (No)
Experimental
Condition 20
Core + Simplified Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + Choice
Behavioral: Core · Behavioral: Simplified Diet Monitoring · Behavioral: Adaptive Activity Goals (Daily) · Behavioral: Message Decision Points (Fixed) · Behavioral: Message Decision Rules (Adaptive) · Behavioral: Message Choice (Yes)
Experimental
Condition 21
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Standard Content+ No Choice
Behavioral: Core · Behavioral: Simplified Diet Monitoring · Behavioral: Adaptive Activity Goals (Daily) · Behavioral: Message Decision Points (Adaptive) · Behavioral: Message Decision Rules (Standard) · Behavioral: Message Choice (No)
Experimental
Condition 22
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Standard Content+ Choice
Behavioral: Core · Behavioral: Simplified Diet Monitoring · Behavioral: Adaptive Activity Goals (Daily) · Behavioral: Message Decision Points (Adaptive) · Behavioral: Message Decision Rules (Standard) · Behavioral: Message Choice (Yes)
Experimental
Condition 23
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice
Behavioral: Core · Behavioral: Simplified Diet Monitoring · Behavioral: Adaptive Activity Goals (Daily) · Behavioral: Message Decision Points (Adaptive) · Behavioral: Message Decision Rules (Adaptive) · Behavioral: Message Choice (No)
Experimental
Condition 24
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ Choice
Behavioral: Core · Behavioral: Simplified Diet Monitoring · Behavioral: Adaptive Activity Goals (Daily) · Behavioral: Message Decision Points (Adaptive) · Behavioral: Message Decision Rules (Adaptive) · Behavioral: Message Choice (Yes)
Experimental
Condition 25
Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Fixed Timing+ Standard Content+ No Choice
Behavioral: Core · Behavioral: Simplified Diet Monitoring · Behavioral: Adaptive Activity Goals (Weekly) · Behavioral: Message Decision Points (Fixed) · Behavioral: Message Decision Rules (Standard) · Behavioral: Message Choice (No)
Experimental
Condition 26
Core + Simplified Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + Choice
Behavioral: Core · Behavioral: Simplified Diet Monitoring · Behavioral: Adaptive Activity Goals (Weekly) · Behavioral: Message Decision Points (Fixed) · Behavioral: Message Decision Rules (Standard) · Behavioral: Message Choice (Yes)
Experimental
Condition 27
Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Fixed Timing+ Adaptive Content+ No Choice
Behavioral: Core · Behavioral: Simplified Diet Monitoring · Behavioral: Adaptive Activity Goals (Weekly) · Behavioral: Message Decision Points (Fixed) · Behavioral: Message Decision Rules (Adaptive) · Behavioral: Message Choice (No)
Experimental
Condition 28
Core + Simplified Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + Choice
Behavioral: Core · Behavioral: Simplified Diet Monitoring · Behavioral: Adaptive Activity Goals (Weekly) · Behavioral: Message Decision Points (Fixed) · Behavioral: Message Decision Rules (Adaptive) · Behavioral: Message Choice (Yes)
Experimental
Condition 29
Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Standard Content+ No Choice
Behavioral: Core · Behavioral: Simplified Diet Monitoring · Behavioral: Adaptive Activity Goals (Weekly) · Behavioral: Message Decision Points (Adaptive) · Behavioral: Message Decision Rules (Standard) · Behavioral: Message Choice (No)
Experimental
Condition 30
Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Standard Content+ Choice
Behavioral: Core · Behavioral: Simplified Diet Monitoring · Behavioral: Adaptive Activity Goals (Weekly) · Behavioral: Message Decision Points (Adaptive) · Behavioral: Message Decision Rules (Standard) · Behavioral: Message Choice (Yes)
Experimental
Condition 31
Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice
Behavioral: Core · Behavioral: Simplified Diet Monitoring · Behavioral: Adaptive Activity Goals (Weekly) · Behavioral: Message Decision Points (Adaptive) · Behavioral: Message Decision Rules (Adaptive) · Behavioral: Message Choice (No)
Experimental
Condition 32
Core + Simplified Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Adaptive Content+Choice
Behavioral: Core · Behavioral: Simplified Diet Monitoring · Behavioral: Adaptive Activity Goals (Weekly) · Behavioral: Message Decision Points (Adaptive) · Behavioral: Message Decision Rules (Adaptive) · Behavioral: Message Choice (Yes)

Interventions

BehavioralCore
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
BehavioralStandard Diet Monitoring
Standard monitoring using smartphone tracking of all calorie intake.
BehavioralSimplified Diet Monitoring
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
BehavioralAdaptive Activity Goals (Daily)
Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
BehavioralAdaptive Activity Goals (Weekly)
Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
BehavioralMessage Decision Points (Fixed)
Message timing is fixed and evaluated at specific times each day to determine message eligibility.
BehavioralMessage Decision Points (Adaptive)
Message timing is adaptive and derived from individual user data to determine message eligibility.
BehavioralMessage Decision Rules (Standard)
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
BehavioralMessage Decision Rules (Adaptive)
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
BehavioralMessage Choice (No)
Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision
BehavioralMessage Choice (Yes)
Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.

What researchers measure

Primary outcomes

Weight (kg)
Estimated mean weight change in kg from baseline to 6 months for each of the two levels of each component (factor) obtained from intent-to-treat (ITT) linear mixed models of analysis of variance. More negative values of weight change indicate greater weight loss (6-month weight - baseline weight).
Time frame: Baseline, 6 months

Secondary outcomes

Weight (kg)
Estimated mean weight change in kg from baseline to 3 months for each of the two levels of each component (factor) obtained from intent-to-treat (ITT) linear mixed models of analysis of variance. More negative values of weight change indicate greater weight loss (3-month weight - baseline weight).
Time frame: Baseline, 3 months
Percent of Participants Reaching >/= 5% Weight Loss
Percent change in body weight will be calculated (6 month weight - baseline weight/100) and determined to be at or above 5% indicating a clinically significant change.
Time frame: Baseline to 6 months
Diet
Change in daily caloric intake from baseline to 6 months as measured using the self-administered National Cancer Institute's Automated Self- Administered 24-hour Recall (ASA-24), a 24-hour recall that is self-administered on a week day and a weekend day at each timepoint. Change calculated as (daily kcal at 6 months - daily kcal at baseline).
Time frame: Baseline, 6 months
Physical Activity
Change in physical activity from baseline to 3 and 6 months as measured using the Paffenbarger Physical Activity Questionnaire (PPAQ). The PPAQ assesses amount of planned and lifestyle associated physical activity performed during a typical week. The PPAQ consists of three components: (1) stair climbing, (2) walking, and (3) sports and recreation. Participants report the frequency and duration of physical activity in the past week. Scoring yields energy expenditure from physical activity per week (kcal/week). Higher scores translate into greater energy expenditure per week (i.e.,better outcome). Range is 0 - no theoretical maximum. Outcome is change in kcal burned per week.
Time frame: Baseline,3 months, 6 months
Sedentary Behavior Score
Change in sedentary behavior from baseline to 3 and 6 months as measured using the 12- item Sedentary Behavior Questionnaire which asks respondents to indicate the number of hours they spend on a typical weekday and a typical weekend day doing each of six activities. The scale ranges from "none" to "6 or more hours" for each item. Higher values on the Sedentary Behavior Questionnaire indicate greater amount of time spent in sedentary behavior. Range is 0 to 24 hours and outcome is change in minutes per day.
Time frame: Baseline, 3 months, 6 months
Autonomy Support Score
Autonomy support at 3 and 6 months. Items are adapted from the Health Care Climate Questionnaire, which is a measure of how the participant perceives support from a healthcare provider, to measure autonomy support from the program. The scale includes 15 items rated on a scale of 1 (strongly disagree) to 7 (strongly agree) (e.g., "I feel that \[the program\] has provided me choices and options.") Scores are calculated by averaging the individual item scores (with item 13 reverse-scored). Higher average scores represent a higher level of perceived autonomy support. Outcomes are the mean value at 3 months and the mean value at 6 months.
Time frame: 3 months, 6 months
Competence for Diet and Physical Activity Scores
Change in perceived competence from baseline to 3 and 6 months as measured using the The Perceived Competence Scale. The Scale measures perceived competence for diet (4 items) and physical activity (4 items). Items are rated on a 7-point Likert scale (1 = not at all true, 7 = very true), and include items such as "I feel confident in my ability to maintain a healthy diet." Scores are summed for the items in the subscale (diet and physical activity) and the range for each subscale is 4 - 28. Greater values indicate higher levels of perceived competence for engaging in positive diet and physical activity behaviors. Scores are summed for the items in each subscale separately (diet and physical activity). Outcomes are change in perceived competence for diet and change in perceived competence for physical activity.
Time frame: Baseline, 3 months, 6 months
Perceived Message Relevance Score
Perceived message relevance at 3 and 6 months as measured using two items used in our previous work and adapted from previous studies of tailored messages. Participants were asked to rate how strongly they disagree or agree with the statements about messages being "written personally for me" and "applied to my life." Responses are on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). The values of the two items are averaged for a final score. Higher values indicate that a participant perceives the messages received in the program are more relevant to them.
Time frame: 3 months, 6 months
Treatment Self-Regulation Score
Change in treatment self-regulation from baseline to 3 and 6 months as measured using the Treatment Self-Regulation Questionnaire (TSRQ). The TSRQ assesses autonomous and controlled motivation for making changes in diet (15 items) and physical activity (15 items). Examples item: "Because I feel that I want to take responsibility for my own health" answered on a scale of 1 (not at all true) to 7 (very true)." Calculating the scores for the sub-scales will consist of averaging the items on that subscale. They are: Autonomous Regulation: 2, 3, 7, 10, 13, 16, 18, 19 Controlled Regulation: 1, 4, 5, 6, 8, 9, 11, 12, 14, 15, 17. Responses to the items within the subscale are averaged with the range of scores being 1 to 7. Higher values on each subscale indicate greater levels of that type of motivation. Outcomes are changes in autonomous and controlled motivation for diet at 3 and 6 months, and changes in autonomous and controlled motivation for activity at 3 and 6 months.
Time frame: Baseline, 3 months, 6 months
Relatedness Score
Relatedness at 3 and 6 months as measured with 3 items adapted from the 8-item Relatedness subscale of the Basic Need Satisfaction at Work Scale. Examples include "The messages demonstrate caring about me as a person" and are scored on a Likert scale from 1 (strongly disagree) to 7 (strongly agree). Responses are averaged with a range of 1 to 7. Higher scores indicate a higher level of perceived relatedness from the intervention messages.
Time frame: 3 months, 6 months
Diet Self-monitoring Adherence
Mean number of days of complete dietary tracking summed over the 6-month study period.
Time frame: Baseline to 6 months (daily)
Weighing Adherence
Mean number of days of self-weighing over the 6 month period.
Time frame: Baseline to 6 months (daily)
Physical Activity Self-monitoring Adherence
Mean number of days of physical activity tracking over the 6 month period as measured by Fitbit tracker wear.
Time frame: Baseline to 6 months (daily)

Results

Posted Jul 20, 2025

Participant flow

Recruitment occurred from Apr 2022 to Dec 2023; remote recruitment across the continental United States. 2510 individuals completed the online screening survey; 841 were initially eligible; out of those, 135 completed informed consent but were ineligible due to no longer being interested in participating or incomplete baseline measurement procedures, and 624 completed informed consent and all baseline assessment procedures and were randomized and enrolled in the study.

Participant flow — Overall Study
Milestone	1: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, No Choice	2: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, Choice	3: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, No Choice	4: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, Choice	5: Standard Diet Monitoring,Daily Adaptive Activity Goal, Adaptive Timing,Standard Rules,No Choice	6: Standard Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice	7:Standard Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, No Choice	8: Standard Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, Choice	9: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Standard Rules, No Choice	10: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Standard Rules, Choice	11: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Adaptive Rules, No Choice	12: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Adaptive Rules, Choice	13:Standard Diet Monitoring,Weekly Adaptive Activity Goal, Adaptive Timing, Standard Rules,No Choice	14:Standard Diet Monitoring, Weekly Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice	15:Standard Diet Monitoring,Weekly Adaptive Activity Goal,Adaptive Timing, Adaptive Rules, No Choice	16: Standard Diet Monitoring, Weekly Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, Choice	17:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, No Choice	18: Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, Choice	19:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, No Choice	20: Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, Choice	21:Simplified Diet Monitoring,Daily Adaptive Activity Goal,Adaptive Timing,Standard Rules, No Choice	22:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice	23:Simplified Diet Monitoring,Daily Adaptive Activity Goal,Adaptive Timing,Adaptive Rules, No Choice	24:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, Choice	25:Simplified Diet Monitoring,Weekly Adaptive Activity Goal, Fixed Timing, Standard Rules, No Choice	26: Simplified Diet Monitoring, Weekly Adaptive Activity Goal, Fixed Timing, Standard Rules, Choice	27:Simplified Diet Monitoring,Weekly Adaptive Activity Goal, Fixed Timing, Adaptive Rules, No Choice	28: Simplified Diet Monitoring, Weekly Adaptive Activity Goal, Fixed Timing, Adaptive Rules, Choice	29:Simplified Diet Monitoring,Weekly Adaptive Activity Goal,Adaptive Timing,Standard Rules,No Choice	30:Simplified Diet Monitoring,Weekly Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice	31:Simplified Diet Monitoring,Weekly Adaptive Activity Goal,Adaptive Timing,Adaptive Rules,No Choice	32:Simplified Diet Monitoring, Weekly Adaptive Activity Goal, Adaptive Timing, Adaptive Rules,Choice
Started	18	21	20	18	20	18	19	20	20	20	20	19	18	19	20	19	20	20	20	19	20	19	20	19	19	20	20	20	20	20	20	19
Completed 3-month visit	17	20	20	18	20	18	19	20	20	20	20	19	18	19	20	19	20	19	19	19	19	19	20	19	19	20	19	20	20	20	19	19
Completed	17	20	18	18	20	16	19	17	19	18	18	18	16	18	18	19	20	17	18	18	18	19	18	16	19	18	19	20	19	20	17	18
Not completed	1	1	2	0	0	2	0	3	1	2	2	1	2	1	2	0	0	3	2	1	2	0	2	3	0	2	1	0	1	0	3	1
Withdrew: Withdrawal by subject	0	1	0	0	0	0	0	2	0	0	0	0	1	1	1	0	0	1	1	1	1	0	0	2	0	0	1	0	0	0	1	0
Withdrew: Lost to follow-up	1	0	2	0	0	2	0	1	1	2	2	1	1	0	1	0	0	2	1	0	1	0	2	1	0	2	0	0	1	0	2	1

Outcome measures

PrimaryWeight (kg)

Estimated mean weight change in kg from baseline to 6 months for each of the two levels of each component (factor) obtained from intent-to-treat (ITT) linear mixed models of analysis of variance. More negative values of weight change indicate greater weight loss (6-month weight - baseline weight).

Time frame:: Baseline, 6 months
Reported as:: Mean · kg

Weight (kg)
kg	Standard Diet Monitoring	Simplified Diet Monitoring	Weekly Adaptive Activity Goals	Daily Adaptive Activity Goals	Fixed Message Decision Points	Adaptive Message Decision Points	Standard Message Decision Rules	Adaptive Message Decision Rules	No Message Choice	Message Choice
Weight (kg)	-3.61 (-4.25 to -2.97)	-3.31 (-3.95 to -2.68)	-3.32 (-3.96 to -2.68)	-3.60 (-4.24 to -2.96)	-3.66 (-4.29 to -3.02)	-3.26 (-3.90 to -2.61)	-3.65 (-4.29 to -3.02)	-3.26 (-3.91 to -2.62)	-3.19 (-3.83 to -2.55)	-3.73 (-4.38 to -3.09)

Statistical analysis

Standard Diet Monitoring vs Simplified Diet Monitoring · Mixed Models Analysis · p = 0.52 · Mean difference (net): 0.30 · 95% CI -0.61 to 1.20Standard dietary monitoring coded as 0 (reference) and simplified dietary monitoring coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.
Weekly Adaptive Activity Goals vs Daily Adaptive Activity Goals · Mixed Models Analysis · p = 0.54 · Mean difference (net): -0.28 · 95% CI -1.19 to 0.63Weekly adaptive goals coded as 0 (reference) and daily adaptive goals coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.
Fixed Message Decision Points vs Adaptive Message Decision Points · Mixed Models Analysis · p = 0.39 · Mean difference (net): 0.40 · 95% CI -0.50 to 1.31Fixed message decision points coded as 0 (reference) and adaptive message decision points coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.
Standard Message Decision Rules vs Adaptive Message Decision Rules · Mixed Models Analysis · p = 0.70 · Mean difference (net): 0.39 · 95% CI -0.52 to 1.30Standard decision rules coded as 0 (reference) and adaptive decision rules coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.
No Message Choice vs Message Choice · Mixed Models Analysis · p = 0.47 · Mean difference (net): -0.55 · 95% CI -1.45 to 0.36No choice points coded as 0 (reference) and Choice coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.

SecondaryWeight (kg)

Estimated mean weight change in kg from baseline to 3 months for each of the two levels of each component (factor) obtained from intent-to-treat (ITT) linear mixed models of analysis of variance. More negative values of weight change indicate greater weight loss (3-month weight - baseline weight).

Time frame:: Baseline, 3 months
Reported as:: Mean · kg

Weight (kg)
kg	Standard Diet Monitoring	Simplified Diet Monitoring	Weekly Adaptive Activity Goals	Daily Adaptive Activity Goals	Fixed Message Decision Points	Adaptive Message Decision Points	Standard Message Decision Rules	Adaptive Message Decision Rules	No Message Choice	Message Choice
Weight (kg)	-2.54 (-2.97 to -2.12)	-2.30 (-2.72 to -1.88)	-2.22 (-2.64 to -1.80)	-2.63 (-3.06 to -2.21)	-2.69 (-3.11 to -2.27)	-2.16 (-2.58 to -1.74)	-2.58 (-3.00 to -2.16)	-2.26 (-2.69 to -1.84)	-2.27 (-2.69 to -1.84)	-2.58 (-3.00 to -2.16)

Statistical analysis

Standard Diet Monitoring vs Simplified Diet Monitoring · Mixed Models Analysis · p = 0.43 · Mean difference (net): 0.24 · 95% CI -0.36 to 0.84Standard dietary monitoring coded as 0 (reference) and simplified dietary monitoring coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.
Weekly Adaptive Activity Goals vs Daily Adaptive Activity Goals · Mixed Models Analysis · p = 0.17 · Mean difference (net): -0.42 · 95% CI -1.01 to 0.18Weekly adaptive goals coded as 0 (reference) and daily adaptive goals coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.
Fixed Message Decision Points vs Adaptive Message Decision Points · Mixed Models Analysis · p = 0.08 · Mean difference (net): 0.53 · 95% CI -0.06 to 1.13Fixed message decision points coded as 0 (reference) and adaptive message decision points coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.
Standard Message Decision Rules vs Adaptive Message Decision Rules · Mixed Models Analysis · p = 0.58 · Mean difference (net): 0.32 · 95% CI -0.28 to 0.91Standard decision rules coded as 0 (reference) and adaptive decision rules coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.
No Message Choice vs Message Choice · Mixed Models Analysis · p = 0.55 · Mean difference (net): -0.32 · 95% CI -0.91 to 0.28No choice points coded as 0 (reference) and Choice coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.

SecondaryPercent of Participants Reaching >/= 5% Weight Loss

Percent change in body weight will be calculated (6 month weight - baseline weight/100) and determined to be at or above 5% indicating a clinically significant change.

Time frame:: Baseline to 6 months
Reported as:: Count of participants · Participants

Percent of Participants Reaching >/= 5% Weight Loss
Participants	Standard Diet Monitoring	Simplified Diet Monitoring	Weekly Adaptive Activity Goals	Daily Adaptive Activity Goals	Fixed Message Decision Points	Adaptive Message Decision Points	Standard Message Decision Rules	Adaptive Message Decision Rules	No Message Choice	Message Choice
Percent of Participants Reaching >/= 5% Weight Loss	100	101	89	112	107	94	101	100	95	106

Statistical analysis

Standard Diet Monitoring vs Simplified Diet Monitoring · Chi-squared · p = 0.95 · Odds ratio (or): 0.99 · 95% CI 0.70 to 1.39Standard dietary monitoring coded as 0 (reference) and simplified dietary monitoring coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.
Weekly Adaptive Activity Goals vs Daily Adaptive Activity Goals · Chi-squared · p = 0.03 · Odds ratio (or): 1.46 · 95% CI 1.03 to 2.05Weekly adaptive activity goals coded as 0 (reference) and daily adaptive activity goals coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.
Fixed Message Decision Points vs Adaptive Message Decision Points · Chi-squared · p = 0.36 · Odds ratio (or): 0.85 · 95% CI 0.60 to 1.20Fixed decision points coded as 0 (reference) and adaptive decision points coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.
Standard Message Decision Rules vs Adaptive Message Decision Rules · Chi-squared · p = 0.95 · Odds ratio (or): 1.01 · 95% CI 0.72 to 1.42Standard decision rules coded as 0 (reference) and adaptive decision rules coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.
No Message Choice vs Message Choice · Chi-squared · p = 0.29 · Odds ratio (or): 1.20 · 95% CI 0.85 to 1.69No message choice coded as 0 (reference) and message choice coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.

SecondaryDiet

Change in daily caloric intake from baseline to 6 months as measured using the self-administered National Cancer Institute's Automated Self- Administered 24-hour Recall (ASA-24), a 24-hour recall that is self-administered on a week day and a weekend day at each timepoint. Change calculated as (daily kcal at 6 months - daily kcal at baseline).

Time frame:: Baseline, 6 months
Reported as:: Mean · kcal/day

Diet
kcal/day	Standard Diet Monitoring	Simplified Diet Monitoring	Weekly Adaptive Activity Goals	Daily Adaptive Activity Goals	Fixed Message Decision Points	Adaptive Message Decision Points	Standard Message Decision Rules	Adaptive Message Decision Rules	No Message Choice	Message Choice
Diet	-378.6 ± 765.8	-485.3 ± 813.4	-470.3 ± 811.3	-391.9 ± 768.8	-452.3 ± 807.2	-411.6 ± 775.5	-439.7 ± 775.7	-424.6 ± 807.1	-476.9 ± 841.6	-386.7 ± 735.3

SecondaryPhysical Activity

Change in physical activity from baseline to 3 and 6 months as measured using the Paffenbarger Physical Activity Questionnaire (PPAQ). The PPAQ assesses amount of planned and lifestyle associated physical activity performed during a typical week. The PPAQ consists of three components: (1) stair climbing, (2) walking, and (3) sports and recreation. Participants report the frequency and duration of physical activity in the past week. Scoring yields energy expenditure from physical activity per week (kcal/week). Higher scores translate into greater energy expenditure per week (i.e.,better outcome). Range is 0 - no theoretical maximum. Outcome is change in kcal burned per week.

Time frame:: Baseline,3 months, 6 months
Reported as:: Mean · kcal/week

Physical Activity
kcal/week	Standard Diet Monitoring	Simplified Diet Monitoring	Weekly Adaptive Activity Goals	Daily Adaptive Activity Goals	Fixed Message Decision Points	Adaptive Message Decision Points	Standard Message Decision Rules	Adaptive Message Decision Rules	No Message Choice	Message Choice
Baseline to 3 Months	180.4 ± 939.5	322.6 ± 1089.8	252.1 ± 967.1	250.8 ± 1072.5	309.3 ± 1074.4	192.9 ± 957.8	268.0 ± 1075.3	234.8 ± 960.1	149.8 ± 934.7	353.2 ± 1089.0
Baseline to 6 Months	167.1 ± 927.9	92.1 ± 861.5	128.0 ± 899.1	131.0 ± 892.7	163.6 ± 911.8	94.4 ± 878.0	131.7 ± 899.5	127.3 ± 892.4	102.9 ± 854.0	156.6 ± 936.2

SecondarySedentary Behavior Score

Change in sedentary behavior from baseline to 3 and 6 months as measured using the 12- item Sedentary Behavior Questionnaire which asks respondents to indicate the number of hours they spend on a typical weekday and a typical weekend day doing each of six activities. The scale ranges from "none" to "6 or more hours" for each item. Higher values on the Sedentary Behavior Questionnaire indicate greater amount of time spent in sedentary behavior. Range is 0 to 24 hours and outcome is change in minutes per day.

Time frame:: Baseline, 3 months, 6 months
Reported as:: Mean · minutes/day

Sedentary Behavior Score
minutes/day	Standard Diet Monitoring	Simplified Diet Monitoring	Weekly Adaptive Activity Goals	Daily Adaptive Activity Goals	Fixed Message Decision Points	Adaptive Message Decision Points	Standard Message Decision Rules	Adaptive Message Decision Rules	No Message Choice	Message Choice
Baseline to 3 Months	-35.3 ± 207.6	-36.1 ± 223.4	-33.9 ± 194.0	-37.6 ± 236.2	-41.1 ± 200.9	-30.3 ± 229.5	-40.9 ± 217.3	-30.5 ± 213.9	-34.1 ± 222.9	-37.4 ± 208.1
Baseline to 6 Months	-22.7 ± 218.9	-34.1 ± 227.0	-11.8 ± 223.7	-45.7 ± 221.1	-39.9 ± 223.7	-16.6 ± 221.8	-28.3 ± 230.1	-28.6 ± 215.9	-28.3 ± 236.8	-28.5 ± 208.1

SecondaryAutonomy Support Score

Autonomy support at 3 and 6 months. Items are adapted from the Health Care Climate Questionnaire, which is a measure of how the participant perceives support from a healthcare provider, to measure autonomy support from the program. The scale includes 15 items rated on a scale of 1 (strongly disagree) to 7 (strongly agree) (e.g., "I feel that \[the program\] has provided me choices and options.") Scores are calculated by averaging the individual item scores (with item 13 reverse-scored). Higher average scores represent a higher level of perceived autonomy support. Outcomes are the mean value at 3 months and the mean value at 6 months.

Time frame:: 3 months, 6 months
Reported as:: Mean · score on a scale

Autonomy Support Score
score on a scale	Standard Diet Monitoring	Simplified Diet Monitoring	Weekly Adaptive Activity Goals	Daily Adaptive Activity Goals	Fixed Message Decision Points	Adaptive Message Decision Points	Standard Message Decision Rules	Adaptive Message Decision Rules	No Message Choice	Message Choice
3 Months	5.14 ± 1.20	5.11 ± 1.11	5.08 ± 1.15	5.17 ± 1.15	5.16 ± 1.15	5.09 ± 1.16	5.12 ± 1.17	5.13 ± 1.13	5.13 ± 1.15	5.12 ± 1.15
6 Months	5.13 ± 1.22	5.08 ± 1.30	5.05 ± 1.25	5.12 ± 1.28	5.08 ± 1.23	5.11 ± 1.26	5.12 ± 1.22	5.09 ± 1.25	5.07 ± 1.29	5.15 ± 1.26

SecondaryCompetence for Diet and Physical Activity Scores

Change in perceived competence from baseline to 3 and 6 months as measured using the The Perceived Competence Scale. The Scale measures perceived competence for diet (4 items) and physical activity (4 items). Items are rated on a 7-point Likert scale (1 = not at all true, 7 = very true), and include items such as "I feel confident in my ability to maintain a healthy diet." Scores are summed for the items in the subscale (diet and physical activity) and the range for each subscale is 4 - 28. Greater values indicate higher levels of perceived competence for engaging in positive diet and physical activity behaviors. Scores are summed for the items in each subscale separately (diet and physical activity). Outcomes are change in perceived competence for diet and change in perceived competence for physical activity.

Time frame:: Baseline, 3 months, 6 months
Reported as:: Mean · score on a scale

Competence for Diet and Physical Activity Scores
score on a scale	Standard Diet Monitoring	Simplified Diet Monitoring	Weekly Adaptive Activity Goals	Daily Adaptive Activity Goals	Fixed Message Decision Points	Adaptive Message Decision Points	Standard Message Decision Rules	Adaptive Message Decision Rules	No Message Choice	Message Choice
Competence for Diet - Baseline to 3 Months	0.88 ± 6.01	0.74 ± 6.36	0.41 ± 6.17	1.23 ± 6.17	0.78 ± 6.22	0.84 ± 6.15	1.32 ± 5.66	0.29 ± 6.64	0.62 ± 6.05	1.00 ± 6.32
Competence for Diet - Baseline to 6 Months	2.03 ± 6.76	1.62 ± 6.81	1.74 ± 6.75	1.90 ± 6.83	1.91 ± 6.97	1.74 ± 6.60	2.26 ± 6.51	1.38 ± 7.03	1.81 ± 6.83	1.83 ± 6.75
Competence for Physical Activity - Baseline to 3 Months	-0.83 ± 6.51	-1.50 ± 6.09	-1.10 ± 6.37	-1.23 ± 6.25	-1.27 ± 6.36	-1.06 ± 6.26	-0.92 ± 6.28	-1.42 ± 6.33	-1.02 ± 6.55	-1.31 ± 6.05
Competence for Physical Activity - Baseline to 6 Months	-0.14 ± 6.67	-1.18 ± 6.57	-0.87 ± 6.65	-0.44 ± 6.62	-0.87 ± 6.84	-0.45 ± 6.41	-0.40 ± 6.40	-0.92 ± 6.86	-0.31 ± 7.03	-1.03 ± 6.20

SecondaryPerceived Message Relevance Score

Perceived message relevance at 3 and 6 months as measured using two items used in our previous work and adapted from previous studies of tailored messages. Participants were asked to rate how strongly they disagree or agree with the statements about messages being "written personally for me" and "applied to my life." Responses are on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). The values of the two items are averaged for a final score. Higher values indicate that a participant perceives the messages received in the program are more relevant to them.

Time frame:: 3 months, 6 months
Reported as:: Mean · score on a scale

Perceived Message Relevance Score
score on a scale	Standard Diet Monitoring	Simplified Diet Monitoring	Weekly Adaptive Activity Goals	Daily Adaptive Activity Goals	Fixed Message Decision Points	Adaptive Message Decision Points	Standard Message Decision Rules	Adaptive Message Decision Rules	No Message Choice	Message Choice
3 Months	3.34 ± 0.97	3.37 ± 0.95	3.29 ± 0.94	3.42 ± 0.98	3.35 ± 0.98	3.36 ± 0.94	3.35 ± 0.96	3.36 ± 0.96	3.40 ± 0.96	3.31 ± 0.96
6 Months	3.36 ± 1.01	3.33 ± 1.05	3.35 ± 0.99	3.35 ± 1.07	3.37 ± 1.01	3.33 ± 1.05	3.34 ± 1.04	3.36 ± 1.02	3.36 ± 1.05	3.33 ± 1.01

SecondaryTreatment Self-Regulation Score

Change in treatment self-regulation from baseline to 3 and 6 months as measured using the Treatment Self-Regulation Questionnaire (TSRQ). The TSRQ assesses autonomous and controlled motivation for making changes in diet (15 items) and physical activity (15 items). Examples item: "Because I feel that I want to take responsibility for my own health" answered on a scale of 1 (not at all true) to 7 (very true)." Calculating the scores for the sub-scales will consist of averaging the items on that subscale. They are: Autonomous Regulation: 2, 3, 7, 10, 13, 16, 18, 19 Controlled Regulation: 1, 4, 5, 6, 8, 9, 11, 12, 14, 15, 17. Responses to the items within the subscale are averaged with the range of scores being 1 to 7. Higher values on each subscale indicate greater levels of that type of motivation. Outcomes are changes in autonomous and controlled motivation for diet at 3 and 6 months, and changes in autonomous and controlled motivation for activity at 3 and 6 months.

Time frame:: Baseline, 3 months, 6 months
Reported as:: Mean · score on a scale

Treatment Self-Regulation Score
score on a scale	Standard Diet Monitoring	Simplified Diet Monitoring	Weekly Adaptive Activity Goals	Daily Adaptive Activity Goals	Fixed Message Decision Points	Adaptive Message Decision Points	Standard Message Decision Rules	Adaptive Message Decision Rules	No Message Choice	Message Choice
Autonomous motivation for diet baseline to 3 months	-0.19 ± 0.93	-0.23 ± 0.87	-0.16 ± 0.87	-0.25 ± 0.92	-0.19 ± 0.85	-0.22 ± 0.94	-0.21 ± 0.90	-0.20 ± 0.90	-0.18 ± 0.89	-0.23 ± 0.91
Autonomous motivation for diet baseline to 6 months	-0.17 ± 1.06	-0.18 ± 0.98	-0.12 ± 0.97	-0.23 ± 1.07	-0.14 ± 1.00	-0.21 ± 1.05	-0.20 ± 1.08	-0.15 ± 0.97	-0.17 ± 1.02	-0.18 ± 1.03
Controlled motivation for diet baseline to 3 months	0.16 ± 1.10	0.06 ± 1.20	0.15 ± 1.17	0.06 ± 1.13	0.07 ± 1.15	0.14 ± 1.15	0.09 ± 1.06	0.13 ± 1.24	0.02 ± 1.17	0.20 ± 1.12
Controlled motivation for diet baseline to 6 months	0.17 ± 1.17	0.07 ± 1.16	0.16 ± 1.16	0.08 ± 1.17	0.12 ± 1.16	0.12 ± 1.17	0.17 ± 1.11	0.07 ± 1.22	0.03 ± 1.15	0.21 ± 1.17
Autonomous motivation for physical activity baseline to 3 months	-0.07 ± 1.04	-0.06 ± 0.94	-0.07 ± 0.94	-0.06 ± 1.04	-0.02 ± 0.96	-0.11 ± 1.02	-0.02 ± 0.99	-0.12 ± 0.99	-0.03 ± 0.97	-0.10 ± 1.01
Autonomous motivation for physical activity baseline to 6 months	-0.01 ± 1.07	0.03 ± 1.02	0.01 ± 0.91	0.02 ± 1.17	0.08 ± 1.00	-0.06 ± 1.09	0.00 ± 1.12	0.03 ± 0.97	0.04 ± 1.09	-0.02 ± 1.00
Controlled motivation for physical activity baseline to 3 months	0.07 ± 1.14	0.14 ± 1.03	0.17 ± 1.04	0.04 ± 1.13	0.09 ± 1.03	0.12 ± 1.14	0.06 ± 1.03	0.16 ± 1.14	0.08 ± 1.08	0.13 ± 1.09
Controlled motivation for physical activity baseline to 6 months	0.06 ± 1.11	0.17 ± 1.11	0.15 ± 1.10	0.08 ± 1.13	0.16 ± 1.07	0.07 ± 1.15	0.10 ± 1.08	0.14 ± 1.14	0.06 ± 1.10	0.17 ± 1.12

SecondaryRelatedness Score

Relatedness at 3 and 6 months as measured with 3 items adapted from the 8-item Relatedness subscale of the Basic Need Satisfaction at Work Scale. Examples include "The messages demonstrate caring about me as a person" and are scored on a Likert scale from 1 (strongly disagree) to 7 (strongly agree). Responses are averaged with a range of 1 to 7. Higher scores indicate a higher level of perceived relatedness from the intervention messages.

Time frame:: 3 months, 6 months
Reported as:: Mean · score on a scale

Relatedness Score
score on a scale	Standard Diet Monitoring	Simplified Diet Monitoring	Weekly Adaptive Activity Goals	Daily Adaptive Activity Goals	Fixed Message Decision Points	Adaptive Message Decision Points	Standard Message Decision Rules	Adaptive Message Decision Rules	No Message Choice	Message Choice
Relatedness at 3 Months	4.91 ± 1.47	4.95 ± 1.40	4.86 ± 1.42	5.01 ± 1.45	4.99 ± 1.42	4.88 ± 1.45	4.91 ± 1.40	4.96 ± 1.48	5.04 ± 1.43	4.83 ± 1.44
Relatedness at 6 Months	4.79 ± 1.57	4.90 ± 1.51	4.83 ± 1.50	4.85 ± 1.58	4.91 ± 1.52	4.77 ± 1.56	4.86 ± 1.53	4.83 ± 1.55	4.93 ± 1.52	4.75 ± 1.55

SecondaryDiet Self-monitoring Adherence

Mean number of days of complete dietary tracking summed over the 6-month study period.

Time frame:: Baseline to 6 months (daily)
Reported as:: Mean · days

Diet Self-monitoring Adherence
days	Standard Diet Monitoring	Simplified Diet Monitoring	Weekly Adaptive Activity Goals	Daily Adaptive Activity Goals	Fixed Message Decision Points	Adaptive Message Decision Points	Standard Message Decision Rules	Adaptive Message Decision Rules	No Message Choice	Message Choice
Diet Self-monitoring Adherence	73.3 ± 51.3	67.9 ± 48.1	69.3 ± 50.1	71.9 ± 49.4	69.2 ± 49.1	72.1 ± 50.4	74.9 ± 51.4	66.3 ± 47.6	69.7 ± 50.4	71.5 ± 49.0

SecondaryWeighing Adherence

Mean number of days of self-weighing over the 6 month period.

Time frame:: Baseline to 6 months (daily)
Reported as:: Mean · days

Weighing Adherence
days	Standard Diet Monitoring	Simplified Diet Monitoring	Weekly Adaptive Activity Goals	Daily Adaptive Activity Goals	Fixed Message Decision Points	Adaptive Message Decision Points	Standard Message Decision Rules	Adaptive Message Decision Rules	No Message Choice	Message Choice
Weighing Adherence	90.2 ± 51.4	87.4 ± 49.6	87.5 ± 50.9	90.0 ± 50.1	87.9 ± 50.6	89.6 ± 50.5	90.5 ± 51.2	87.0 ± 49.8	88.6 ± 50.8	89.0 ± 50.3

SecondaryPhysical Activity Self-monitoring Adherence

Mean number of days of physical activity tracking over the 6 month period as measured by Fitbit tracker wear.

Time frame:: Baseline to 6 months (daily)
Reported as:: Mean · days

Physical Activity Self-monitoring Adherence
days	Standard Diet Monitoring	Simplified Diet Monitoring	Weekly Adaptive Activity Goals	Daily Adaptive Activity Goals	Fixed Message Decision Points	Adaptive Message Decision Points	Standard Message Decision Rules	Adaptive Message Decision Rules	No Message Choice	Message Choice
Physical Activity Self-monitoring Adherence	134.1 ± 46.5	133.4 ± 45.3	133.2 ± 46.3	134.3 ± 45.4	132.7 ± 46.7	134.8 ± 45.0	133.9 ± 45.9	133.6 ± 45.8	131.4 ± 48.2	136.2 ± 43.2

Adverse events

Collected over up to 6 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Condition 1	0/18 (0%)	0/18 (0%)	5/18 (27.8%)
Condition 2	0/21 (0%)	0/21 (0%)	2/21 (9.5%)
Condition 3	0/20 (0%)	0/20 (0%)	3/20 (15%)
Condition 4	0/18 (0%)	0/18 (0%)	5/18 (27.8%)
Condition 5	0/20 (0%)	0/20 (0%)	2/20 (10%)
Condition 6	0/18 (0%)	0/18 (0%)	4/18 (22.2%)
Condition 7	0/19 (0%)	0/19 (0%)	1/19 (5.3%)
Condition 8	0/20 (0%)	0/20 (0%)	3/20 (15%)
Condition 9	0/20 (0%)	1/20 (5%)	4/20 (20%)
Condition 10	0/20 (0%)	0/20 (0%)	7/20 (35%)
Condition 11	1/20 (5%)	1/20 (5%)	4/20 (20%)
Condition 12	2/19 (10.5%)	1/19 (5.3%)	1/19 (5.3%)
Condition 13	0/18 (0%)	0/18 (0%)	2/18 (11.1%)
Condition 14	1/19 (5.3%)	1/19 (5.3%)	3/19 (15.8%)
Condition 15	0/20 (0%)	0/20 (0%)	2/20 (10%)
Condition 16	0/19 (0%)	0/19 (0%)	4/19 (21.1%)
Condition 17	0/20 (0%)	0/20 (0%)	3/20 (15%)
Condition 18	0/20 (0%)	0/20 (0%)	1/20 (5%)
Condition 19	0/20 (0%)	0/20 (0%)	1/20 (5%)
Condition 20	2/19 (10.5%)	2/19 (10.5%)	3/19 (15.8%)
Condition 21	0/20 (0%)	0/20 (0%)	2/20 (10%)
Condition 22	1/19 (5.3%)	1/19 (5.3%)	4/19 (21.1%)
Condition 23	0/20 (0%)	0/20 (0%)	2/20 (10%)
Condition 24	0/19 (0%)	0/19 (0%)	0/19 (0%)
Condition 25	1/19 (5.3%)	1/19 (5.3%)	5/19 (26.3%)
Condition 26	1/20 (5%)	1/20 (5%)	3/20 (15%)
Condition 27	0/20 (0%)	0/20 (0%)	3/20 (15%)
Condition 28	0/20 (0%)	0/20 (0%)	2/20 (10%)
Condition 29	0/20 (0%)	0/20 (0%)	4/20 (20%)
Condition 30	0/20 (0%)	0/20 (0%)	6/20 (30%)
Condition 31	0/20 (0%)	0/20 (0%)	1/20 (5%)
Condition 32	0/19 (0%)	0/19 (0%)	5/19 (26.3%)

Most frequent serious events

Most frequent serious events
Event	Condition 1	Condition 2	Condition 3	Condition 4	Condition 5	Condition 6	Condition 7	Condition 8	Condition 9	Condition 10	Condition 11	Condition 12	Condition 13	Condition 14	Condition 15	Condition 16	Condition 17	Condition 18	Condition 19	Condition 20	Condition 21	Condition 22	Condition 23	Condition 24	Condition 25	Condition 26	Condition 27	Condition 28	Condition 29	Condition 30	Condition 31	Condition 32
MiscarriagePregnancy, puerperium and perinatal conditions	0/18	0/21	0/20	0/18	0/20	0/18	0/19	0/20	0/20	0/20	0/20	0/19	0/18	0/19	0/20	0/19	0/20	0/20	0/20	1/19	0/20	0/19	0/20	0/19	0/19	0/20	0/20	0/20	0/20	0/20	0/20	0/19
Leg injuryInjury, poisoning and procedural complications	0/18	0/21	0/20	0/18	0/20	0/18	0/19	0/20	0/20	0/20	0/20	0/19	0/18	0/19	0/20	0/19	0/20	0/20	0/20	0/19	0/20	0/19	0/20	0/19	1/19	0/20	0/20	0/20	0/20	0/20	0/20	0/19
Hospitalized for transient ischemic attacksCardiac disorders	0/18	0/21	0/20	0/18	0/20	0/18	0/19	0/20	0/20	0/20	0/20	1/19	0/18	0/19	0/20	0/19	0/20	0/20	0/20	0/19	0/20	0/19	0/20	0/19	0/19	0/20	0/20	0/20	0/20	0/20	0/20	0/19
Gall bladder removalSurgical and medical procedures	0/18	0/21	0/20	0/18	0/20	0/18	0/19	0/20	1/20	0/20	0/20	1/19	0/18	0/19	0/20	0/19	0/20	0/20	0/20	1/19	0/20	0/19	0/20	0/19	0/19	0/20	0/20	0/20	0/20	0/20	0/20	0/19
Appendicitis, surgery and hospitalizationSurgical and medical procedures	0/18	0/21	0/20	0/18	0/20	0/18	0/19	0/20	0/20	0/20	0/20	0/19	0/18	0/19	0/20	0/19	0/20	0/20	0/20	0/19	0/20	1/19	0/20	0/19	0/19	0/20	0/20	0/20	0/20	0/20	0/20	0/19
Ileostomy secondary to parastomal herniaSurgical and medical procedures	0/18	0/21	0/20	0/18	0/20	0/18	0/19	0/20	0/20	0/20	0/20	0/19	0/18	1/19	0/20	0/19	0/20	0/20	0/20	0/19	0/20	0/19	0/20	0/19	0/19	0/20	0/20	0/20	0/20	0/20	0/20	0/19
SurgerySurgical and medical procedures	0/18	0/21	0/20	0/18	0/20	0/18	0/19	0/20	0/20	0/20	0/20	0/19	0/18	0/19	0/20	0/19	0/20	0/20	0/20	0/19	0/20	0/19	0/20	0/19	0/19	1/20	0/20	0/20	0/20	0/20	0/20	0/19
Foot fractureInjury, poisoning and procedural complications	0/18	0/21	0/20	0/18	0/20	0/18	0/19	0/20	0/20	0/20	1/20	0/19	0/18	0/19	0/20	0/19	0/20	0/20	0/20	0/19	0/20	0/19	0/20	0/19	0/19	0/20	0/20	0/20	0/20	0/20	0/20	0/19

Most frequent other events

Showing 10 of 44

Most frequent other events
Event	Condition 1	Condition 2	Condition 3	Condition 4	Condition 5	Condition 6	Condition 7	Condition 8	Condition 9	Condition 10	Condition 11	Condition 12	Condition 13	Condition 14	Condition 15	Condition 16	Condition 17	Condition 18	Condition 19	Condition 20	Condition 21	Condition 22	Condition 23	Condition 24	Condition 25	Condition 26	Condition 27	Condition 28	Condition 29	Condition 30	Condition 31	Condition 32
Muscle strainMusculoskeletal and connective tissue disorders	0/18	0/21	1/20	0/18	0/20	2/18	0/19	0/20	0/20	1/20	2/20	0/19	0/18	0/19	0/20	0/19	0/20	0/20	0/20	0/19	0/20	0/19	1/20	0/19	3/19	0/20	0/20	1/20	0/20	0/20	0/20	0/19
Motor vehicle accidentGeneral disorders	1/18	0/21	1/20	1/18	0/20	1/18	0/19	0/20	0/20	1/20	3/20	0/19	0/18	0/19	0/20	0/19	1/20	0/20	1/20	0/19	1/20	0/19	0/20	0/19	0/19	0/20	1/20	0/20	0/20	2/20	0/20	0/19
Wrist sprainInjury, poisoning and procedural complications	0/18	0/21	0/20	0/18	0/20	0/18	0/19	0/20	0/20	0/20	0/20	0/19	0/18	0/19	0/20	1/19	0/20	0/20	0/20	0/19	0/20	0/19	0/20	0/19	2/19	0/20	0/20	0/20	0/20	0/20	0/20	0/19
Ankle sprainInjury, poisoning and procedural complications	1/18	0/21	0/20	0/18	1/20	0/18	0/19	0/20	0/20	0/20	0/20	0/19	0/18	0/19	0/20	0/19	0/20	0/20	0/20	1/19	0/20	1/19	0/20	0/19	0/19	0/20	0/20	0/20	0/20	1/20	0/20	1/19
AnxietyPsychiatric disorders	0/18	0/21	0/20	1/18	0/20	0/18	0/19	0/20	0/20	1/20	0/20	0/19	0/18	0/19	0/20	0/19	0/20	0/20	0/20	0/19	0/20	0/19	0/20	0/19	0/19	1/20	0/20	0/20	0/20	0/20	0/20	0/19
Back sprainMusculoskeletal and connective tissue disorders	1/18	0/21	0/20	0/18	0/20	0/18	0/19	0/20	0/20	0/20	0/20	0/19	0/18	0/19	0/20	0/19	0/20	0/20	0/20	0/19	0/20	0/19	0/20	0/19	0/19	0/20	0/20	0/20	0/20	0/20	0/20	0/19
FaintingNervous system disorders	0/18	0/21	0/20	1/18	0/20	0/18	0/19	0/20	1/20	0/20	0/20	0/19	1/18	0/19	1/20	0/19	0/20	0/20	0/20	0/19	0/20	0/19	0/20	0/19	0/19	0/20	1/20	0/20	1/20	1/20	1/20	0/19
Knee injuryInjury, poisoning and procedural complications	0/18	0/21	1/20	1/18	0/20	0/18	0/19	0/20	1/20	0/20	0/20	0/19	0/18	0/19	0/20	0/19	0/20	0/20	0/20	0/19	0/20	0/19	0/20	0/19	0/19	0/20	0/20	0/20	1/20	0/20	0/20	0/19
Hand and wrist painInjury, poisoning and procedural complications	0/18	0/21	0/20	1/18	0/20	0/18	0/19	0/20	0/20	0/20	0/20	0/19	0/18	0/19	0/20	0/19	0/20	0/20	0/20	0/19	0/20	0/19	0/20	0/19	0/19	0/20	0/20	0/20	0/20	0/20	0/20	0/19
DiabetesMetabolism and nutrition disorders	1/18	0/21	0/20	0/18	0/20	0/18	0/19	0/20	0/20	1/20	0/20	0/19	0/18	0/19	0/20	0/19	0/20	0/20	0/20	0/19	0/20	0/19	0/20	0/19	0/19	0/20	0/20	0/20	0/20	0/20	0/20	0/19

Baseline characteristics

Baseline population included all randomized participants, N=624.

Age, Continuous
Age, Continuous(years)	1: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, No Choice	2: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, Choice	3: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, No Choice	4: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, Choice	5: Standard Diet Monitoring,Daily Adaptive Activity Goal, Adaptive Timing,Standard Rules,No Choice	6: Standard Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice	7:Standard Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, No Choice	8: Standard Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, Choice	9: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Standard Rules, No Choice	10: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Standard Rules, Choice	11: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Adaptive Rules, No Choice	12: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Adaptive Rules, Choice	13:Standard Diet Monitoring,Weekly Adaptive Activity Goal, Adaptive Timing, Standard Rules,No Choice	14:Standard Diet Monitoring, Weekly Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice	15:Standard Diet Monitoring,Weekly Adaptive Activity Goal,Adaptive Timing, Adaptive Rules, No Choice	16: Standard Diet Monitoring, Weekly Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, Choice	17:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, No Choice	18: Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, Choice	19:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, No Choice	20: Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, Choice	21:Simplified Diet Monitoring,Daily Adaptive Activity Goal,Adaptive Timing,Standard Rules, No Choice	22:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice	23:Simplified Diet Monitoring,Daily Adaptive Activity Goal,Adaptive Timing,Adaptive Rules, No Choice	24:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, Choice	25:Simplified Diet Monitoring,Weekly Adaptive Activity Goal, Fixed Timing, Standard Rules, No Choice	26: Simplified Diet Monitoring, Weekly Adaptive Activity Goal, Fixed Timing, Standard Rules, Choice	27:Simplified Diet Monitoring,Weekly Adaptive Activity Goal, Fixed Timing, Adaptive Rules, No Choice	28: Simplified Diet Monitoring, Weekly Adaptive Activity Goal, Fixed Timing, Adaptive Rules, Choice	29:Simplified Diet Monitoring,Weekly Adaptive Activity Goal,Adaptive Timing,Standard Rules,No Choice	30:Simplified Diet Monitoring,Weekly Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice	31:Simplified Diet Monitoring,Weekly Adaptive Activity Goal,Adaptive Timing,Adaptive Rules,No Choice	32:Simplified Diet Monitoring, Weekly Adaptive Activity Goal, Adaptive Timing, Adaptive Rules,Choice	Total
Mean	30.4 ± 5.6	30.9 ± 5.4	33.2 ± 4.4	31.4 ± 5.0	31.3 ± 4.6	32.1 ± 4.5	29.0 ± 4.7	29.9 ± 5.7	30.1 ± 4.7	33.5 ± 4.0	30.6 ± 4.7	32.4 ± 4.9	30.3 ± 3.2	32.4 ± 4.5	32.8 ± 3.9	31.2 ± 5.7	30.9 ± 4.5	30.0 ± 5.3	29.5 ± 5.3	30.5 ± 4.9	31.4 ± 4.3	30.9 ± 4.8	30.5 ± 6.0	27.1 ± 5.4	33.0 ± 3.9	30.7 ± 6.2	32.9 ± 3.8	31.2 ± 4.7	31.2 ± 5.0	32.6 ± 4.5	29.7 ± 4.9	33.6 ± 4.1	31.2 ± 4.9

Sex/Gender, Customized
Sex/Gender, Customized(Participants)	1: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, No Choice	2: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, Choice	3: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, No Choice	4: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, Choice	5: Standard Diet Monitoring,Daily Adaptive Activity Goal, Adaptive Timing,Standard Rules,No Choice	6: Standard Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice	7:Standard Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, No Choice	8: Standard Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, Choice	9: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Standard Rules, No Choice	10: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Standard Rules, Choice	11: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Adaptive Rules, No Choice	12: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Adaptive Rules, Choice	13:Standard Diet Monitoring,Weekly Adaptive Activity Goal, Adaptive Timing, Standard Rules,No Choice	14:Standard Diet Monitoring, Weekly Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice	15:Standard Diet Monitoring,Weekly Adaptive Activity Goal,Adaptive Timing, Adaptive Rules, No Choice	16: Standard Diet Monitoring, Weekly Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, Choice	17:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, No Choice	18: Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, Choice	19:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, No Choice	20: Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, Choice	21:Simplified Diet Monitoring,Daily Adaptive Activity Goal,Adaptive Timing,Standard Rules, No Choice	22:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice	23:Simplified Diet Monitoring,Daily Adaptive Activity Goal,Adaptive Timing,Adaptive Rules, No Choice	24:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, Choice	25:Simplified Diet Monitoring,Weekly Adaptive Activity Goal, Fixed Timing, Standard Rules, No Choice	26: Simplified Diet Monitoring, Weekly Adaptive Activity Goal, Fixed Timing, Standard Rules, Choice	27:Simplified Diet Monitoring,Weekly Adaptive Activity Goal, Fixed Timing, Adaptive Rules, No Choice	28: Simplified Diet Monitoring, Weekly Adaptive Activity Goal, Fixed Timing, Adaptive Rules, Choice	29:Simplified Diet Monitoring,Weekly Adaptive Activity Goal,Adaptive Timing,Standard Rules,No Choice	30:Simplified Diet Monitoring,Weekly Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice	31:Simplified Diet Monitoring,Weekly Adaptive Activity Goal,Adaptive Timing,Adaptive Rules,No Choice	32:Simplified Diet Monitoring, Weekly Adaptive Activity Goal, Adaptive Timing, Adaptive Rules,Choice	Total
Female	13	14	11	12	10	9	14	14	14	16	16	11	12	9	13	11	14	15	14	16	14	14	10	14	14	14	16	13	12	12	13	14	418
Male	4	7	9	6	9	8	5	6	6	4	4	8	6	10	7	8	6	5	6	3	6	5	10	5	5	6	4	7	8	8	7	5	203
Don't know	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Prefer not to answer	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	1: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, No Choice	2: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, Choice	3: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, No Choice	4: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, Choice	5: Standard Diet Monitoring,Daily Adaptive Activity Goal, Adaptive Timing,Standard Rules,No Choice	6: Standard Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice	7:Standard Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, No Choice	8: Standard Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, Choice	9: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Standard Rules, No Choice	10: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Standard Rules, Choice	11: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Adaptive Rules, No Choice	12: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Adaptive Rules, Choice	13:Standard Diet Monitoring,Weekly Adaptive Activity Goal, Adaptive Timing, Standard Rules,No Choice	14:Standard Diet Monitoring, Weekly Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice	15:Standard Diet Monitoring,Weekly Adaptive Activity Goal,Adaptive Timing, Adaptive Rules, No Choice	16: Standard Diet Monitoring, Weekly Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, Choice	17:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, No Choice	18: Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, Choice	19:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, No Choice	20: Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, Choice	21:Simplified Diet Monitoring,Daily Adaptive Activity Goal,Adaptive Timing,Standard Rules, No Choice	22:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice	23:Simplified Diet Monitoring,Daily Adaptive Activity Goal,Adaptive Timing,Adaptive Rules, No Choice	24:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, Choice	25:Simplified Diet Monitoring,Weekly Adaptive Activity Goal, Fixed Timing, Standard Rules, No Choice	26: Simplified Diet Monitoring, Weekly Adaptive Activity Goal, Fixed Timing, Standard Rules, Choice	27:Simplified Diet Monitoring,Weekly Adaptive Activity Goal, Fixed Timing, Adaptive Rules, No Choice	28: Simplified Diet Monitoring, Weekly Adaptive Activity Goal, Fixed Timing, Adaptive Rules, Choice	29:Simplified Diet Monitoring,Weekly Adaptive Activity Goal,Adaptive Timing,Standard Rules,No Choice	30:Simplified Diet Monitoring,Weekly Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice	31:Simplified Diet Monitoring,Weekly Adaptive Activity Goal,Adaptive Timing,Adaptive Rules,No Choice	32:Simplified Diet Monitoring, Weekly Adaptive Activity Goal, Adaptive Timing, Adaptive Rules,Choice	Total
Hispanic or Latino	2	3	3	3	2	1	1	3	6	3	1	3	4	1	3	1	1	3	3	1	0	5	3	2	2	2	4	1	5	4	1	2	79
Not Hispanic or Latino	15	18	16	15	17	17	18	17	14	16	19	16	14	18	17	18	19	17	17	16	20	13	17	17	17	18	16	19	15	16	18	17	537
Unknown or Not Reported	1	0	1	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	2	0	1	0	0	0	0	0	0	0	0	1	0	8

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	1: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, No Choice	2: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, Choice	3: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, No Choice	4: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, Choice	5: Standard Diet Monitoring,Daily Adaptive Activity Goal, Adaptive Timing,Standard Rules,No Choice	6: Standard Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice	7:Standard Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, No Choice	8: Standard Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, Choice	9: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Standard Rules, No Choice	10: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Standard Rules, Choice	11: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Adaptive Rules, No Choice	12: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Adaptive Rules, Choice	13:Standard Diet Monitoring,Weekly Adaptive Activity Goal, Adaptive Timing, Standard Rules,No Choice	14:Standard Diet Monitoring, Weekly Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice	15:Standard Diet Monitoring,Weekly Adaptive Activity Goal,Adaptive Timing, Adaptive Rules, No Choice	16: Standard Diet Monitoring, Weekly Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, Choice	17:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, No Choice	18: Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, Choice	19:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, No Choice	20: Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, Choice	21:Simplified Diet Monitoring,Daily Adaptive Activity Goal,Adaptive Timing,Standard Rules, No Choice	22:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice	23:Simplified Diet Monitoring,Daily Adaptive Activity Goal,Adaptive Timing,Adaptive Rules, No Choice	24:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, Choice	25:Simplified Diet Monitoring,Weekly Adaptive Activity Goal, Fixed Timing, Standard Rules, No Choice	26: Simplified Diet Monitoring, Weekly Adaptive Activity Goal, Fixed Timing, Standard Rules, Choice	27:Simplified Diet Monitoring,Weekly Adaptive Activity Goal, Fixed Timing, Adaptive Rules, No Choice	28: Simplified Diet Monitoring, Weekly Adaptive Activity Goal, Fixed Timing, Adaptive Rules, Choice	29:Simplified Diet Monitoring,Weekly Adaptive Activity Goal,Adaptive Timing,Standard Rules,No Choice	30:Simplified Diet Monitoring,Weekly Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice	31:Simplified Diet Monitoring,Weekly Adaptive Activity Goal,Adaptive Timing,Adaptive Rules,No Choice	32:Simplified Diet Monitoring, Weekly Adaptive Activity Goal, Adaptive Timing, Adaptive Rules,Choice	Total
American Indian or Alaska Native	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0	1	4
Asian	4	1	2	0	2	5	2	1	2	1	4	2	2	4	0	5	4	4	1	2	2	1	6	1	0	3	1	3	2	3	3	0	73
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Black or African American	2	7	2	3	4	2	2	4	3	4	6	1	2	5	3	5	4	6	3	5	4	4	3	3	6	2	7	2	4	1	5	8	122
White	8	11	12	13	13	9	14	15	14	11	8	15	11	10	15	9	10	8	12	7	13	10	10	13	10	14	8	14	12	13	10	9	361
More than one race	2	2	2	1	0	2	0	0	1	2	1	1	3	0	2	0	1	1	2	3	1	2	1	1	0	1	4	0	1	2	0	1	40
Unknown or Not Reported	2	0	2	0	1	0	1	0	0	2	1	0	0	0	0	0	1	0	2	2	0	2	0	1	2	0	0	1	1	1	2	0	24

Weight (lb)
Weight (lb)(pounds)	1: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, No Choice	2: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, Choice	3: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, No Choice	4: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, Choice	5: Standard Diet Monitoring,Daily Adaptive Activity Goal, Adaptive Timing,Standard Rules,No Choice	6: Standard Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice	7:Standard Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, No Choice	8: Standard Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, Choice	9: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Standard Rules, No Choice	10: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Standard Rules, Choice	11: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Adaptive Rules, No Choice	12: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Adaptive Rules, Choice	13:Standard Diet Monitoring,Weekly Adaptive Activity Goal, Adaptive Timing, Standard Rules,No Choice	14:Standard Diet Monitoring, Weekly Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice	15:Standard Diet Monitoring,Weekly Adaptive Activity Goal,Adaptive Timing, Adaptive Rules, No Choice	16: Standard Diet Monitoring, Weekly Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, Choice	17:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, No Choice	18: Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, Choice	19:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, No Choice	20: Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, Choice	21:Simplified Diet Monitoring,Daily Adaptive Activity Goal,Adaptive Timing,Standard Rules, No Choice	22:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice	23:Simplified Diet Monitoring,Daily Adaptive Activity Goal,Adaptive Timing,Adaptive Rules, No Choice	24:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, Choice	25:Simplified Diet Monitoring,Weekly Adaptive Activity Goal, Fixed Timing, Standard Rules, No Choice	26: Simplified Diet Monitoring, Weekly Adaptive Activity Goal, Fixed Timing, Standard Rules, Choice	27:Simplified Diet Monitoring,Weekly Adaptive Activity Goal, Fixed Timing, Adaptive Rules, No Choice	28: Simplified Diet Monitoring, Weekly Adaptive Activity Goal, Fixed Timing, Adaptive Rules, Choice	29:Simplified Diet Monitoring,Weekly Adaptive Activity Goal,Adaptive Timing,Standard Rules,No Choice	30:Simplified Diet Monitoring,Weekly Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice	31:Simplified Diet Monitoring,Weekly Adaptive Activity Goal,Adaptive Timing,Adaptive Rules,No Choice	32:Simplified Diet Monitoring, Weekly Adaptive Activity Goal, Adaptive Timing, Adaptive Rules,Choice	Total
Mean	207.7 ± 52.3	208.5 ± 35.1	206.8 ± 45.1	214.9 ± 38.7	210.5 ± 41.5	212.1 ± 36.3	195.7 ± 36.5	200.3 ± 43.3	203.1 ± 33.4	208.8 ± 33.2	195.2 ± 32.4	224.4 ± 36.2	190.8 ± 28.5	233.9 ± 45.6	218.2 ± 39.8	185.7 ± 34.3	200.7 ± 49.7	195.0 ± 47.7	219.5 ± 53.4	201.5 ± 41.8	206.1 ± 36.3	211.0 ± 39.6	207.5 ± 45.6	216.3 ± 45.1	210.6 ± 33.6	203.8 ± 40.4	203.0 ± 37.1	200.9 ± 33.9	218.3 ± 42.0	198.5 ± 22.3	206.0 ± 49.8	215.8 ± 33.5	207.2 ± 40.3

Study locations

1 site

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27514, United States

References and documents

Publications

Nezami BT, Valle CG, Wasser HM, Hurley L, Hatley KE, Tate DF. Optimizing a mobile just-in-time adaptive intervention (JITAI) for weight loss in young adults: Rationale and design of the AGILE factorial randomized trial. Contemp Clin Trials. 2025 Mar;150:107808. doi: 10.1016/j.cct.2025.107808. Epub 2025 Jan 15. PubMed 39824380 ↗

Study documents

Protocol and statistical analysis plan · Feb 20, 2023
Informed consent form · Feb 20, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04922216
Lead sponsor: University of North Carolina, Chapel Hill
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party: Sponsor
First posted: Jun 10, 2021
Start date: Apr 28, 2022
Primary completion: Jun 20, 2024
Completion: Jul 1, 2024
Results posted: Jul 20, 2025
Last update: Jul 20, 2025

Study contacts

Deborah F. Tate, PhD

principal investigator · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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