An interventional study of self-monitoring of body weight and self-monitoring of diet in Obesity, Overweight and Weight Loss, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-04-25.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
This study is a randomized controlled trial that compares 3 self-monitoring approaches for weight loss. GoalTracker is a standalone, technology-based intervention using a commercial smartphone app (MyFitnessPal) and email.
The investigators hypothesize that the group that delays diet tracking and receives additional intervention components (weekly personalized feedback, skills training, and action plans) will have greater weight loss at the end of the 12-week intervention and at 6-month followup, compared to (a) an intervention group that simultaneously tracks weight and diet for all 12 weeks and receives the same additional components, and (b) a control group that tracks only diet.
This study will examine whether a digital health intervention (GoalTracker) can promote weight loss among adults who are overweight or obese. Engagement in self-monitoring often declines over time, which is then associated with suboptimal weight loss. Finding ways to improve self-monitoring engagement, particularly in the first month of treatment, is needed. Promoting mastery, self-efficacy, and self-regulatory skills may help with maintaining high engagement.
The investigators aim to enroll 105 participants. All groups are asked to self-monitor daily on their smartphone using the free commercial mobile application MyFitnessPal over the course of the 12-week intervention.
Specifically, the study aims to...
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 105 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
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Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* in this Sequential eHealth intervention, participants are asked to self-monitor only their body weight for the first month, then for months 2 and 3 they will be asked to also self-monitor their diet * participants are asked to use the MyFitnessPal app for self-monitoring * given goal to lose 5% weight by end of intervention (3 months) * weekly personalized feedback via email * weekly skills training materials (behavioral modification lessons; tips on using different features of the app) via email * weekly action plans via email
Behavioral: self-monitoring of body weight · Behavioral: self-monitoring of diet · Behavioral: weekly personalized feedback + lessons + action plans
* in this Simultaneous eHealth intervention, participants are asked to self-monitor both their body weight and diet for 3 months * participants are asked to use the MyFitnessPal app for self-monitoring * given goal to lose 5% weight by end of intervention (3 months) * weekly personalized feedback via email * weekly skills training materials (behavioral modification lessons; tips on using different features of the app) via email * weekly action plans via email
Behavioral: self-monitoring of body weight · Behavioral: self-monitoring of diet · Behavioral: weekly personalized feedback + lessons + action plans
* participants are asked to self-monitor their diet for 3 months * participants are asked to use the MyFitnessPal app for self-monitoring * given goal to lose 5% weight by end of intervention (3 months)
Behavioral: self-monitoring of diet
- weigh daily for 3 months and track their weight using the MyFitnessPal mobile app
* track their diet (food and drinks) daily using the MyFitnessPal mobile app * when they are asked to track diet will vary based on the arm
- these are additional evidence-based intervention components
Change in Weight
Weight will be collected in kilograms using a calibrated digital scale
Time frame: Baseline, 1 month, 3 months
Proportion of Individuals Achieving ≥ 5% Weight Loss
Weight will be collected in kilograms using a calibrated digital scale
Time frame: Baseline to 3 months
Change in Caloric Intake
Caloric intake will will be assessed using the Automated Self-Administered 24-hour Dietary Intake Assessment (ASA24), an online dietary recall tool developed by the National Cancer Institute
Time frame: Baseline, 3 months
Change in Weight at 6 Months
At 6-months (i.e., 3 months post-intervention), self-reported weight will be collected
Time frame: 6 months
Self-Monitoring Engagement
Frequency of self-monitoring weight and diet; Consistency of self-monitoring weight and diet
Time frame: Baseline to 1-month and 3 months
Self-Efficacy
Weight Efficacy Lifestyle Questionnaire (WEL) (20 items) will assess self-efficacy for eating. Separate surveys that were adapted will assess self-efficacy for self-monitoring of diet and weight.
Time frame: Baseline, 1 month, 3 months
Mastery
The Automaticity subscale of The Self-Report Habit Index (SRHI) will assess mastery of self-monitoring diet and weight (4 items each).
Time frame: Baseline, 1 month, 3 months
Self-Regulation
The Three Factor Eating Questionnaire-R18 (TFEQ-R18) (18 items) will assess self-regulation for controlled eating. Separate surveys that were adapted will assess self-regulation for self-monitoring of diet and weight.
Time frame: Baseline, 1 month, 3 months
Physical Activity
Paffenbarger Activity Questionnaire (7 items) will assess physical activity.
Time frame: Baseline, 3 months
Sleep Quality
Medical Outcomes Study (MOS) Sleep (12 items) will assess sleep quality.
Time frame: Baseline, 1 month, 3 months
Perceived Stress
Perceived Stress Scale (10 items)
Time frame: Baseline, 3 months
Depressive Symptoms
Patient Health Questionnaire (PHQ-8) will assess depressive symptoms.
Time frame: Baseline, 1 month, 3 months
Health-Related Quality of Life
EuroQol-5 Dimension (EQ-5D) (5 items) will assess health-related quality of life.
Time frame: Baseline, 1 month, 3 months
Plan to share: No — This data set is initially being used for the principal investigator's (Michele Lanpher) doctoral dissertation.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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