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CompletedNCT01814072Opt-INUpdated Feb 1, 2023Results posted

Opt-IN: Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity

A Phase 2/3 interventional study of 12 Telephone Coaching Sessions and 24 Telephone Coaching Sessions in Weight Loss, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-01.

Sponsored by Northwestern University · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
562
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The overall objective of the proposed research is to use an innovative methodological framework, the Multiphase Optimization Strategy (MOST), to design, for the first time, an optimized, scalable version of a technology-supported intensive lifestyle intervention (INLI) for obesity. MOST involves highly efficient randomized experimentation to assess the effects of individual treatment components, and thereby identify which components and component levels make important contributions to the overall program effect on weight loss. This information then guides assembly of an optimized treatment package that achieves target outcomes with least resource consumption and participant burden. Because the intervention strategies being tested minimize in-person coaching and leverage technology that participants already own, the new optimized intervention, to be called Opt-IN, will be more scalable than traditional INLIs. Opt-IN will thus enjoy greatly increased reach, and enable significant progress in the fight against obesity.

Read the detailed description

The goal of the proposed study is to determine the optimal composition of a technology supported intervention for obesity that minimizes expense and burden to participants, while achieving 6 month weight loss outcomes comparable or superior to those achieved by the current full cost, full burden form of INLIs. All intervention components to be examined were selected based on the Opt-IN model's prediction that they enhance behavioral adherence to weight regulation via the designated pathways. The five components to be tested will be: (1) coaching intensity (12 vs. 24 phone sessions), (2) text messaging (No vs. Yes), (3) progress report to participant's primary care provider (No vs. Yes), (4) recommendation to use meal replacements (No vs. Yes), (5) training participants' self-selected buddies to be supportive (No vs. Yes).

02

Conditions studied

  • Weight Loss

Browse trials for

03

In context

Weight Loss

1,766 studies on the registry are indexed under Weight Loss; 278 are open to participants now.

This study's enrollment of 562 is above the median of 73 across 1,496 interventional studies indexed under Weight Loss.

Browse Weight Loss studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 18 and 60 years old
  • BMI 25-40 kg/m2
  • Weight stable (no loss or gain >25 lbs for the past 6 months)
  • Not enrolled in any formal weight loss program or taking anti-obesity medications, but interested in losing weight.
  • Own a Smartphone and be willing to install the Opt-IN app
  • Able to use the app to record dietary intake and weight onto the Smartphone

"Buddy" participants must:

  • 18 years of age or older
  • Have access to a computer and internet
  • Be willing to undergo "Buddy Training" and participate in 4 webinars
  • Be willing to provide support and encouragement to the participant

Exclusion criteria

Exclusion Criteria:

  • Unstable medical conditions (uncontrolled hypertension, diabetes, unstable angina pectoris, myocardial infarction, transient ischemic attack, cancer undergoing active treatment, or cerebrovascular accident within the past six months)
  • History of diabetes requiring insulin supplementation, Crohn's Disease, or a diagnosis of obstructive sleep apnea requiring intervention (i.e. CPAP)
  • Use an assistive device for mobility (e.g., wheelchair, walker, cane)
  • Plantar fasciitis
  • Hospitalization for a psychiatric disorder within the past 5 years
  • At risk for adverse cardiovascular (CVD) events with moderate intensity activity
  • Cannot read the study questionnaires
  • Committed to following an incompatible dietary regimen
  • Not be pregnant, trying to get pregnant, or lactating
  • Bulimia, binge eating disorder, current substance abuse or dependence (besides nicotine dependence) or report active suicidal ideation
  • Low motivation to change
  • Cannot live with a current or past Opt-IN participant
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
562 participants (actual)

Study arms

  • Experimental
    Condition 1

    1) Lifestyle Core; 2) 12 Telephone Coaching Sessions; 3) Report to Primary Care Physician

    Behavioral: 12 Telephone Coaching Sessions · Behavioral: Report to Primary Care Physician

  • Experimental
    Condition 2

    1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements; 5) Buddy training via webinars

    Behavioral: 12 Telephone Coaching Sessions · Behavioral: Report to Primary Care Physician · Behavioral: Recommendations to use meal replacements · Behavioral: Buddy Training

  • Experimental
    Condition 3

    1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars

    Behavioral: 12 Telephone Coaching Sessions · Behavioral: Report to Primary Care Physician · Behavioral: Text Messages · Behavioral: Buddy Training

  • Experimental
    Condition 4

    1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages

    Behavioral: 12 Telephone Coaching Sessions · Behavioral: Report to Primary Care Physician · Behavioral: Text Messages · Behavioral: Recommendations to use meal replacements

  • Experimental
    Condition 5

    1) Lifestyle Core; 2) 12 telephone sessions; 3) Buddy training via webinars

    Behavioral: 12 Telephone Coaching Sessions · Behavioral: Buddy Training

  • Experimental
    Condition 6

    1) Lifestyle Core; 2) 12 telephone coaching sessions; 3) Recommendations to use meal replacements

    Behavioral: 12 Telephone Coaching Sessions · Behavioral: Recommendations to use meal replacements

  • Experimental
    Condition 7

    1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages

    Behavioral: 12 Telephone Coaching Sessions · Behavioral: Text Messages

  • Experimental
    Condition 8

    1) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars

    Behavioral: 12 Telephone Coaching Sessions · Behavioral: Text Messages · Behavioral: Recommendations to use meal replacements · Behavioral: Buddy Training

  • Experimental
    Condition 9

    1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician

    Behavioral: 24 Telephone Coaching Sessions · Behavioral: Report to Primary Care Physician

  • Experimental
    Condition 10

    1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Buddy training via webinars

    Behavioral: 24 Telephone Coaching Sessions · Behavioral: Report to Primary Care Physician · Behavioral: Recommendations to use meal replacements · Behavioral: Buddy Training

  • Experimental
    Condition 11

    1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars

    Behavioral: 24 Telephone Coaching Sessions · Behavioral: Report to Primary Care Physician · Behavioral: Text Messages · Behavioral: Buddy Training

  • Experimental
    Condition 12

    1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages

    Behavioral: 24 Telephone Coaching Sessions · Behavioral: Report to Primary Care Physician · Behavioral: Text Messages · Behavioral: Recommendations to use meal replacements

  • Experimental
    Condition 13

    1) Lifestyle Core; 2) 24 telephone sessions; 3) Buddy training via webinars

    Behavioral: 24 Telephone Coaching Sessions · Behavioral: Buddy Training

  • Experimental
    Condition 14

    1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Recommendation to use meal replacements

    Behavioral: 24 Telephone Coaching Sessions · Behavioral: Recommendations to use meal replacements

  • Experimental
    Condition 15

    1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages

    Behavioral: 24 Telephone Coaching Sessions · Behavioral: Text Messages

  • Experimental
    Condition 16

    1) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars

    Behavioral: 24 Telephone Coaching Sessions · Behavioral: Text Messages · Behavioral: Recommendations to use meal replacements · Behavioral: Buddy Training

  • Experimental
    Condition 17

    1) Lifestyle Core; 2) 12 Telephone Coaching Sessions

    Behavioral: 12 Telephone Coaching Sessions

  • Experimental
    Condition 18

    1) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendations to use meal replacements; 4) Buddy training via webinars

    Behavioral: 12 Telephone Coaching Sessions · Behavioral: Recommendations to use meal replacements · Behavioral: Buddy Training

  • Experimental
    Condition 19

    1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars

    Behavioral: 12 Telephone Coaching Sessions · Behavioral: Text Messages · Behavioral: Buddy Training

  • Experimental
    Condition 20

    1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements

    Behavioral: 12 Telephone Coaching Sessions · Behavioral: Text Messages · Behavioral: Recommendations to use meal replacements

  • Experimental
    Condition 21

    1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars

    Behavioral: Report to Primary Care Physician · Behavioral: Buddy Training

  • Experimental
    Condition 22

    1) Lifestyle Core; 2) 12 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements

    Behavioral: Report to Primary Care Physician

  • Experimental
    Condition 23

    1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages

    Behavioral: 12 Telephone Coaching Sessions · Behavioral: Report to Primary Care Physician · Behavioral: Text Messages

  • Experimental
    Condition 24

    1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars

    Behavioral: 12 Telephone Coaching Sessions · Behavioral: Report to Primary Care Physician · Behavioral: Text Messages · Behavioral: Recommendations to use meal replacements · Behavioral: Buddy Training

  • Experimental
    Condition 25

    1) Lifestyle Core; 2) 24 telephone coaching sessions

    Behavioral: 24 Telephone Coaching Sessions

  • Experimental
    Condition 26

    1) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Buddy training via webinars

    Behavioral: 24 Telephone Coaching Sessions · Behavioral: Recommendations to use meal replacements · Behavioral: Buddy Training

  • Experimental
    Condition 27

    1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars

    Behavioral: 24 Telephone Coaching Sessions · Behavioral: Text Messages · Behavioral: Buddy Training

  • Experimental
    Condition 28

    1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements

    Behavioral: 24 Telephone Coaching Sessions · Behavioral: Text Messages · Behavioral: Recommendations to use meal replacements

  • Experimental
    Condition 29

    1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars

    Behavioral: 24 Telephone Coaching Sessions · Behavioral: Report to Primary Care Physician · Behavioral: Buddy Training

  • Experimental
    Condition 30

    1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements

    Behavioral: 24 Telephone Coaching Sessions · Behavioral: Report to Primary Care Physician · Behavioral: Recommendations to use meal replacements

  • Experimental
    Condition 31

    1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages

    Behavioral: 24 Telephone Coaching Sessions · Behavioral: Report to Primary Care Physician · Behavioral: Text Messages

  • Experimental
    Condition 32

    1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars

    Behavioral: 24 Telephone Coaching Sessions · Behavioral: Report to Primary Care Physician · Behavioral: Text Messages · Behavioral: Recommendations to use meal replacements · Behavioral: Buddy Training

Interventions

  • Behavioral12 Telephone Coaching Sessions

    Participants will receive 12 telephone coaching sessions

  • Behavioral24 Telephone Coaching Sessions

    Participants will receive 24 telephone coaching sessions

  • BehavioralReport to Primary Care Physician

    Participants will have a report detailing their weight loss progress sent to their primary care physician

  • BehavioralText Messages

    Participants will receive regular text messages

  • BehavioralRecommendations to use meal replacements

    Participants will receive recommendations from their coach to use meal replacements

  • BehavioralBuddy Training

    Participants will have a buddy that will be trained via webinars to be a supportive buddy

06

What researchers measure

Primary outcomes

  1. Weight Change (kg) From Baseline to Month 6, Main Effect of Time

    Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis).

    Time frame: From Baseline to Month 6

  2. Weight Change (kg) From Baseline to Month 6, Time by Factor Interaction

    Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis). This outcome measure is reported as an additional effect beyond that of Outcome Measure 1 (each component has it's own weight loss effect that is above and beyond the weight change calculated in the Outcome Measure 1 analyses).

    Time frame: From Baseline to Month 6

Secondary outcomes

  1. Intervention for <$500

    Using the results from primary aim 1, an intervention with only active treatment components with the largest treatment effect that can be obtained for implementation costs of $500 or less was identified and built.

    Time frame: 6 months

Other outcomes

  1. Treatment Adherence

    Treatment adherence is a hypothesized mediator that will be operationalized as the number of treatment sessions completed divided by the number of treatment sessions offered (12 or 24)

    Time frame: 6 months

  2. Self-monitoring Adherence

    Self-monitoring is a hypothesized mediator that will be operationalized as the number of days recording weight, dietary intake, and physical activity

    Time frame: 6 months

  3. Self-efficacy

    Self-efficacy is an exploratory mediator that will be assessed to examine treatment effects on confidence about performing two categories of behaviors associated with weight loss: diet and physical activity

    Time frame: 6 months

  4. Self-Regulation

    Self-regulation is an exploratory mediator that will be assessed using the Three Factor Eating Questionnaire and Treatment Self-Regulation Questionnaire

    Time frame: 6 months

  5. Supportive Accountability

    Supportive accountability is an exploratory mediator that will be measured by assessing two constructs that define supportive accountability: therapeutic alliance and perceived autonomy support

    Time frame: 6 months

  6. Facilitation

    Facilitation is an exploratory mediator that will be measured by rating how much the tools provided by the study have changed their environment and by the Weight Management Support Inventory

    Time frame: 6 months

07

Results

Posted Jan 5, 2021

Participant flow

8593 were screened. 1159 attended orientation. 1078 signed consent. 562 were randomized.

Participant flow — Overall Study
Milestone1. 12 Calls, PCP2. 12 Calls, PCP, MR, Buddy3. 12 Calls, PCP, Texts, Buddy4. 12 Calls, PCP, Texts, MR5. 12 Calls, Buddy6. 12 Calls, MR7. 12 Calls, Texts8. 12 Calls, Texts, MR, Buddy9. 24 Calls, PCP10. 24 Calls, PCP, MR, Buddy11. 24 Calls, PCP, Texts, Buddy12. 24 Calls, PCP, Texts, MR13. 24 Calls, Buddy14. 24 Calls, MR15. 24 Calls, Texts16. 24 Calls, Texts, MR, Buddy17. 12 Calls18. 12 Calls, MR, Buddy19. 12 Calls, Texts, Buddy20. 12 Calls, Texts, MR21. 12 Calls, PCP, Buddy22. 12 Calls, PCP, MR23. 12 Calls PCP, Texts24. 12 Calls, PCP, Texts, MR, Buddy25. 24 Calls26. 24 Calls, MR, Buddy27. 24 Calls, Texts, Buddy28. 24 Calls, Texts, MR29. 24 Calls, PCP, Buddy30. 24 Calls, PCP, MR31. 24 Calls, PCP, Texts32. 24 Calls, PCP, Texts, MR, Buddy
Started1818181818181818191818181818181817181716161717181716181718171717
3-mo visit1518161815151618181518171616161616161413151715181314171415161617
Intent to treat42304641351232323135214162244320
Completed1416151814121417161317161516151614171411141613171114161314141517
Not completed42304641351232323135214162244320
Withdrew: Lost to follow-up22202331231221213133213141123320
Withdrew: Withdrawal by subject20102310120011110002001021121000

Outcome measures

PrimaryWeight Change (kg) From Baseline to Month 6, Main Effect of Time

Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis).

Time frame:
From Baseline to Month 6
Reported as:
Mean · Kg
Weight Change (kg) From Baseline to Month 6, Main Effect of Time
KgAll Reporting Groups
Weight Change (kg) From Baseline to Month 6, Main Effect of Time-4.8 (-5.3 to -4.4)
Statistical analysis
  • All Reporting Groups · Mixed Models Analysis · p = <.001
PrimaryWeight Change (kg) From Baseline to Month 6, Time by Factor Interaction

Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis). This outcome measure is reported as an additional effect beyond that of Outcome Measure 1 (each component has it's own weight loss effect that is above and beyond the weight change calculated in the Outcome Measure 1 analyses).

Time frame:
From Baseline to Month 6
Reported as:
Mean · Kg
Weight Change (kg) From Baseline to Month 6, Time by Factor Interaction
KgCoaching CallsPCP ReportsText MessagesMeal ReplacementsBuddy Training
Weight Change (kg) From Baseline to Month 6, Time by Factor Interaction.1244 (-.3026 to .5513)-.0226 (-.4495 to .4044).0840 (-.3429 to .5109).1081 (-.3188 to .5350)-.4353 (-.8622 to -.0084)
Statistical analysis
  • Coaching Calls · Mixed Models Analysis · p = 0.567 · Estimated change: 0.1244 · 95% CI -.3026 to .5513
  • PCP Reports · Mixed Models Analysis · p = 0.917 · Estimated change: -0.0226 · 95% CI -.4495 to .4044
  • Text Messages · Mixed Models Analysis · p = 0.699 · Estimated change: 0.084 · 95% CI -.3429 to .5109
  • Meal Replacements · Mixed Models Analysis · p = 0.619 · Estimated change: 0.1081 · 95% CI -.3188 to .5350
  • Buddy Training · Mixed Models Analysis · p = 0.046 · Estimated change: -0.4353 · 95% CI -.8622 to -.0084
SecondaryIntervention for <$500

Using the results from primary aim 1, an intervention with only active treatment components with the largest treatment effect that can be obtained for implementation costs of $500 or less was identified and built.

Time frame:
6 months
Reported as:
Number · dollars
Intervention for <$500
dollarsAll Reporting Groups
Intervention for <$500427
Statistical analysis
  • All Reporting Groups · Mixed Models Analysis · p = 0.051 · Estimated change: 0.424 · 95% CI -0.002 to 0.850
Other pre-specifiedTreatment Adherence

Treatment adherence is a hypothesized mediator that will be operationalized as the number of treatment sessions completed divided by the number of treatment sessions offered (12 or 24)

Time frame:
6 months

Results for this outcome have not been posted.

Other pre-specifiedSelf-monitoring Adherence

Self-monitoring is a hypothesized mediator that will be operationalized as the number of days recording weight, dietary intake, and physical activity

Time frame:
6 months

Results for this outcome have not been posted.

Other pre-specifiedSelf-efficacy

Self-efficacy is an exploratory mediator that will be assessed to examine treatment effects on confidence about performing two categories of behaviors associated with weight loss: diet and physical activity

Time frame:
6 months

Results for this outcome have not been posted.

Other pre-specifiedSelf-Regulation

Self-regulation is an exploratory mediator that will be assessed using the Three Factor Eating Questionnaire and Treatment Self-Regulation Questionnaire

Time frame:
6 months

Results for this outcome have not been posted.

Other pre-specifiedSupportive Accountability

Supportive accountability is an exploratory mediator that will be measured by assessing two constructs that define supportive accountability: therapeutic alliance and perceived autonomy support

Time frame:
6 months

Results for this outcome have not been posted.

Other pre-specifiedFacilitation

Facilitation is an exploratory mediator that will be measured by rating how much the tools provided by the study have changed their environment and by the Weight Management Support Inventory

Time frame:
6 months

Results for this outcome have not been posted.

Adverse events

Collected over Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Condition 10/18 (0%)0/18 (0%)6/18 (33.3%)
Condition 20/18 (0%)0/18 (0%)8/18 (44.4%)
Condition 30/18 (0%)0/18 (0%)7/18 (38.9%)
Condition 40/18 (0%)0/18 (0%)4/18 (22.2%)
Condition 50/18 (0%)1/18 (5.6%)4/18 (22.2%)
Condition 60/18 (0%)0/18 (0%)2/18 (11.1%)
Condition 70/18 (0%)0/18 (0%)5/18 (27.8%)
Condition 80/18 (0%)0/18 (0%)8/18 (44.4%)
Condition 90/19 (0%)0/19 (0%)8/18 (44.4%)
Condition 100/18 (0%)0/18 (0%)8/18 (44.4%)
Condition 110/18 (0%)0/18 (0%)4/18 (22.2%)
Condition 120/18 (0%)0/18 (0%)9/18 (50%)
Condition 130/18 (0%)0/18 (0%)7/18 (38.9%)
Condition 140/18 (0%)0/18 (0%)8/18 (44.4%)
Condition 150/18 (0%)0/18 (0%)8/18 (44.4%)
Condition 160/18 (0%)1/18 (5.6%)8/18 (44.4%)
Condition 170/17 (0%)0/17 (0%)5/17 (29.4%)
Condition 180/18 (0%)0/18 (0%)2/18 (11.1%)
Condition 190/17 (0%)0/17 (0%)1/17 (5.9%)
Condition 200/16 (0%)0/16 (0%)2/16 (12.5%)
Condition 210/16 (0%)0/16 (0%)2/16 (12.5%)
Condition 220/17 (0%)0/17 (0%)2/17 (11.8%)
Condition 230/17 (0%)0/17 (0%)1/17 (5.9%)
Condition 240/18 (0%)0/18 (0%)2/18 (11.1%)
Condition 250/17 (0%)0/17 (0%)3/17 (17.6%)
Condition 260/16 (0%)0/16 (0%)2/16 (12.5%)
Condition 270/18 (0%)0/18 (0%)3/18 (16.7%)
Condition 280/17 (0%)0/17 (0%)4/17 (23.5%)
Condition 290/18 (0%)0/18 (0%)3/18 (16.7%)
Condition 300/17 (0%)0/17 (0%)2/17 (11.8%)
Condition 310/17 (0%)0/17 (0%)3/17 (17.6%)
Condition 320/17 (0%)0/17 (0%)1/17 (5.9%)
Most frequent serious events
Most frequent serious events
EventCondition 1Condition 2Condition 3Condition 4Condition 5Condition 6Condition 7Condition 8Condition 9Condition 10Condition 11Condition 12Condition 13Condition 14Condition 15Condition 16Condition 17Condition 18Condition 19Condition 20Condition 21Condition 22Condition 23Condition 24Condition 25Condition 26Condition 27Condition 28Condition 29Condition 30Condition 31Condition 32
Brain bleedInjury, poisoning and procedural complications0/180/180/180/180/180/180/180/180/190/180/180/180/180/180/181/180/170/180/170/160/160/170/170/180/170/160/180/170/180/170/170/17
severe head injuryInjury, poisoning and procedural complications0/180/180/180/181/180/180/180/180/190/180/180/180/180/180/180/180/170/180/170/160/160/170/170/180/170/160/180/170/180/170/170/17
Most frequent other events
Showing 10 of 63
Most frequent other events
EventCondition 1Condition 2Condition 3Condition 4Condition 5Condition 6Condition 7Condition 8Condition 9Condition 10Condition 11Condition 12Condition 13Condition 14Condition 15Condition 16Condition 17Condition 18Condition 19Condition 20Condition 21Condition 22Condition 23Condition 24Condition 25Condition 26Condition 27Condition 28Condition 29Condition 30Condition 31Condition 32
food poisoningInfections and infestations0/180/181/180/180/180/180/183/180/180/180/180/180/180/180/182/180/170/180/170/160/160/170/170/180/170/160/180/170/180/170/170/17
sinus infectionInfections and infestations0/180/180/180/180/180/180/180/181/181/180/180/180/181/181/183/180/170/180/170/160/160/170/170/180/170/160/180/170/180/170/170/17
muscle sorenessInjury, poisoning and procedural complications1/180/180/181/181/181/181/181/181/183/181/181/181/181/181/182/181/170/180/170/161/160/170/170/180/170/160/180/172/180/170/170/17
joint sorenessInjury, poisoning and procedural complications1/181/181/181/181/180/181/180/180/182/181/181/181/180/182/183/181/170/180/171/160/160/170/170/181/170/161/180/170/180/170/170/17
bronchitisInfections and infestations0/180/180/180/180/180/180/180/182/180/180/180/180/180/181/180/180/170/180/170/160/160/170/170/180/171/160/180/170/180/170/170/17
dental procedureSurgical and medical procedures1/180/180/180/181/180/180/180/182/181/180/180/180/180/180/180/180/170/181/170/160/160/170/170/180/170/160/180/170/180/170/170/17
muscle strainInjury, poisoning and procedural complications2/181/180/180/180/181/181/180/181/180/181/182/181/181/180/181/180/170/180/170/160/160/170/170/181/170/160/181/170/180/170/171/17
ankle sprainInjury, poisoning and procedural complications0/182/181/180/180/180/180/181/180/180/180/180/181/180/181/180/181/170/180/170/160/160/170/170/180/170/161/180/170/180/170/170/17
lacerationInjury, poisoning and procedural complications0/180/180/180/180/180/180/180/182/180/180/181/180/180/180/180/180/170/180/170/160/160/170/170/180/170/160/181/170/180/170/170/17
migraineInjury, poisoning and procedural complications0/180/180/180/180/180/180/180/180/181/180/180/180/182/180/180/180/170/180/170/160/160/170/170/180/170/160/180/170/180/170/170/17

Baseline characteristics

Baseline population included all randomized participants (562).

Age, Continuous
Age, Continuous(years)1. 12 Calls, PCP2. 12 Calls, PCP, MR, Buddy3. 12 Calls, PCP, Texts, Buddy4. 12 Calls, PCP, Texts, MR5. 12 Calls, Buddy6. 12 Calls, MR7. 12 Calls, Texts8. 12 Calls, Texts, MR, Buddy9. 24 Calls, PCP10. 24 Calls, PCP, MR, Buddy11. 24 Calls, PCP, Texts, Buddy12. 24 Calls, PCP, Texts, MR13. 24 Calls, Buddy14. 24 Calls, MR15. 24 Calls, Texts16. 24 Calls, Texts, MR, Buddy17. 12 Calls18. 12 Calls, MR, Buddy19. 12 Calls, Texts, Buddy20. 12 Calls, Texts, MR21. 12 Calls, PCP, Buddy22. 12 Calls, PCP, MR23. 12 Calls PCP, Texts24. 12 Calls, PCP, Texts, MR, Buddy25. 24 Calls26. 24 Calls, MR, Buddy27. 24 Calls, Texts, Buddy28. 24 Calls, Texts, MR29. 24 Calls, PCP, Buddy30. 24 Calls, PCP, MR31. 24 Calls, PCP, Texts32. 24 Calls, PCP, Texts, MR, BuddyTotal
Mean40.0 ± 8.643.2 ± 14.241.7 ± 10.940.2 ± 11.231.4 ± 9.140.5 ± 9.940.8 ± 12.239.4 ± 12.939.5 ± 8.338.7 ± 8.939.1 ± 11.240.6 ± 12.040.4 ± 9.136.3 ± 10.639.8 ± 12.835.8 ± 11.838.2 ± 12.039.2 ± 10.537.4 ± 10.932.2 ± 7.136.7 ± 6.040.3 ± 10.840.1 ± 11.637.9 ± 12.835.7 ± 9.647.3 ± 10.235.1 ± 9.041.0 ± 10.139.1 ± 11.737.2 ± 9.940.6 ± 12.839.9 ± 12.038.9 ± 10.9
Sex: Female, Male
Sex: Female, Male(Participants)1. 12 Calls, PCP2. 12 Calls, PCP, MR, Buddy3. 12 Calls, PCP, Texts, Buddy4. 12 Calls, PCP, Texts, MR5. 12 Calls, Buddy6. 12 Calls, MR7. 12 Calls, Texts8. 12 Calls, Texts, MR, Buddy9. 24 Calls, PCP10. 24 Calls, PCP, MR, Buddy11. 24 Calls, PCP, Texts, Buddy12. 24 Calls, PCP, Texts, MR13. 24 Calls, Buddy14. 24 Calls, MR15. 24 Calls, Texts16. 24 Calls, Texts, MR, Buddy17. 12 Calls18. 12 Calls, MR, Buddy19. 12 Calls, Texts, Buddy20. 12 Calls, Texts, MR21. 12 Calls, PCP, Buddy22. 12 Calls, PCP, MR23. 12 Calls PCP, Texts24. 12 Calls, PCP, Texts, MR, Buddy25. 24 Calls26. 24 Calls, MR, Buddy27. 24 Calls, Texts, Buddy28. 24 Calls, Texts, MR29. 24 Calls, PCP, Buddy30. 24 Calls, PCP, MR31. 24 Calls, PCP, Texts32. 24 Calls, PCP, Texts, MR, BuddyTotal
Female1515151515151515161515151515151514141412131414141413141414141313459
Male33333333333333333434333433434344103
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)1. 12 Calls, PCP2. 12 Calls, PCP, MR, Buddy3. 12 Calls, PCP, Texts, Buddy4. 12 Calls, PCP, Texts, MR5. 12 Calls, Buddy6. 12 Calls, MR7. 12 Calls, Texts8. 12 Calls, Texts, MR, Buddy9. 24 Calls, PCP10. 24 Calls, PCP, MR, Buddy11. 24 Calls, PCP, Texts, Buddy12. 24 Calls, PCP, Texts, MR13. 24 Calls, Buddy14. 24 Calls, MR15. 24 Calls, Texts16. 24 Calls, Texts, MR, Buddy17. 12 Calls18. 12 Calls, MR, Buddy19. 12 Calls, Texts, Buddy20. 12 Calls, Texts, MR21. 12 Calls, PCP, Buddy22. 12 Calls, PCP, MR23. 12 Calls PCP, Texts24. 12 Calls, PCP, Texts, MR, Buddy25. 24 Calls26. 24 Calls, MR, Buddy27. 24 Calls, Texts, Buddy28. 24 Calls, Texts, MR29. 24 Calls, PCP, Buddy30. 24 Calls, PCP, MR31. 24 Calls, PCP, Texts32. 24 Calls, PCP, Texts, MR, BuddyTotal
Hispanic or Latino1218161115181613161618171317171713161214131415161516181416151517489
Not Hispanic or Latino4014301232014100423221222002221053
Unknown or Not Reported2013001300001011002012000001001020
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)1. 12 Calls, PCP2. 12 Calls, PCP, MR, Buddy3. 12 Calls, PCP, Texts, Buddy4. 12 Calls, PCP, Texts, MR5. 12 Calls, Buddy6. 12 Calls, MR7. 12 Calls, Texts8. 12 Calls, Texts, MR, Buddy9. 24 Calls, PCP10. 24 Calls, PCP, MR, Buddy11. 24 Calls, PCP, Texts, Buddy12. 24 Calls, PCP, Texts, MR13. 24 Calls, Buddy14. 24 Calls, MR15. 24 Calls, Texts16. 24 Calls, Texts, MR, Buddy17. 12 Calls18. 12 Calls, MR, Buddy19. 12 Calls, Texts, Buddy20. 12 Calls, Texts, MR21. 12 Calls, PCP, Buddy22. 12 Calls, PCP, MR23. 12 Calls PCP, Texts24. 12 Calls, PCP, Texts, MR, Buddy25. 24 Calls26. 24 Calls, MR, Buddy27. 24 Calls, Texts, Buddy28. 24 Calls, Texts, MR29. 24 Calls, PCP, Buddy30. 24 Calls, PCP, MR31. 24 Calls, PCP, Texts32. 24 Calls, PCP, Texts, MR, BuddyTotal
White/Caucasian10151112161515101514141212151514131591411141214121314913101316417
Black3343221543445233123121431135422187
Asian2020011001010001002010002100001016
American Indian or Alaska Native200000000001000000000000000200005
Native Hawaiian or Other Pacific Islander000000000000010000000000000000001
Other/Unknown1013001300001000313122112111151036
Weight (kg)
Weight (kg)(Kilograms)1. 12 Calls, PCP2. 12 Calls, PCP, MR, Buddy3. 12 Calls, PCP, Texts, Buddy4. 12 Calls, PCP, Texts, MR5. 12 Calls, Buddy6. 12 Calls, MR7. 12 Calls, Texts8. 12 Calls, Texts, MR, Buddy9. 24 Calls, PCP10. 24 Calls, PCP, MR, Buddy11. 24 Calls, PCP, Texts, Buddy12. 24 Calls, PCP, Texts, MR13. 24 Calls, Buddy14. 24 Calls, MR15. 24 Calls, Texts16. 24 Calls, Texts, MR, Buddy17. 12 Calls18. 12 Calls, MR, Buddy19. 12 Calls, Texts, Buddy20. 12 Calls, Texts, MR21. 12 Calls, PCP, Buddy22. 12 Calls, PCP, MR23. 12 Calls PCP, Texts24. 12 Calls, PCP, Texts, MR, Buddy25. 24 Calls26. 24 Calls, MR, Buddy27. 24 Calls, Texts, Buddy28. 24 Calls, Texts, MR29. 24 Calls, PCP, Buddy30. 24 Calls, PCP, MR31. 24 Calls, PCP, Texts32. 24 Calls, PCP, Texts, MR, BuddyTotal
Mean88.9 ± 10.691.2 ± 14.087.3 ± 12.088.8 ± 14.090.4 ± 11.390.0 ± 13.397.8 ± 13.387.3 ± 13.494.4 ± 14.793.1 ± 12.997.6 ± 14.488.1 ± 13.489.6 ± 12.987.2 ± 13.994.3 ± 14.791.3 ± 11.388.4 ± 13.790.2 ± 15.290.8 ± 14.883.3 ± 9.892.9 ± 14.886.1 ± 10.598.0 ± 15.390.5 ± 17.680.7 ± 12.289.8 ± 9.990.1 ± 12.085.5 ± 10.889.7 ± 13.493.7 ± 16.686.8 ± 11.586.1 ± 16.090.0 ± 13.6
08

Study locations

1 site
  • Northwestern University
    Chicago, Illinois 60611, United States
09

References and documents

Publications

  • Collins LM, Murphy SA, Strecher V. The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. Am J Prev Med. 2007 May;32(5 Suppl):S112-8. doi: 10.1016/j.amepre.2007.01.022. PubMed 17466815 ↗
  • Nahum-Shani I, Smith SN, Spring BJ, Collins LM, Witkiewitz K, Tewari A, Murphy SA. Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support. Ann Behav Med. 2018 May 18;52(6):446-462. doi: 10.1007/s12160-016-9830-8. PubMed 27663578 ↗
  • Baker TB, Smith SS, Bolt DM, Loh WY, Mermelstein R, Fiore MC, Piper ME, Collins LM. Implementing Clinical Research Using Factorial Designs: A Primer. Behav Ther. 2017 Jul;48(4):567-580. doi: 10.1016/j.beth.2016.12.005. Epub 2017 Jan 7. PubMed 28577591 ↗
  • Pfammatter AF, Nahum-Shani I, DeZelar M, Scanlan L, McFadden HG, Siddique J, Hedeker D, Spring B. SMART: Study protocol for a sequential multiple assignment randomized controlled trial to optimize weight loss management. Contemp Clin Trials. 2019 Jul;82:36-45. doi: 10.1016/j.cct.2019.05.007. Epub 2019 May 23. PubMed 31129369 ↗
  • Nahum-Shani I, Dziak JJ, Collins LM. Multilevel factorial designs with experiment-induced clustering. Psychol Methods. 2018 Sep;23(3):458-479. doi: 10.1037/met0000128. Epub 2017 Apr 6. PubMed 28383950 ↗
  • Terry PE, Brown N, Arnett DK, Cushman M, Spring B, Halpern SD, Burke LE, Grossmeier J, Goetzel R, Lang J, Calitz C, Terry PE, Sanchez E. The Art of Health Promotion ideas for improving health outcomes. Am J Health Promot. 2016 Sep;30(7):563-82. doi: 10.1177/0890117116668866. No abstract available. PubMed 27670659 ↗
  • Pellegrini CA, Conroy DE, Phillips SM, Pfammatter AF, McFadden HG, Spring B. Daily and Seasonal Influences on Dietary Self-monitoring Using a Smartphone Application. J Nutr Educ Behav. 2018 Jan;50(1):56-61.e1. doi: 10.1016/j.jneb.2016.12.004. PubMed 29325663 ↗
  • Welch WA, Spring B, Phillips SM, Siddique J. Moderating Effects of Weather-Related Factors on a Physical Activity Intervention. Am J Prev Med. 2018 May;54(5):e83-e89. doi: 10.1016/j.amepre.2018.01.025. Epub 2018 Mar 15. PubMed 29551330 ↗
  • Burke LE, Ma J, Azar KM, Bennett GG, Peterson ED, Zheng Y, Riley W, Stephens J, Shah SH, Suffoletto B, Turan TN, Spring B, Steinberger J, Quinn CC; American Heart Association Publications Committee of the Council on Epidemiology and Prevention, Behavior Change Committee of the Council on Cardiometabolic Health, Council on Cardiovascular and Stroke Nursing, Council on Functional Genomics and Translational Biology, Council on Quality of Care and Outcomes Research, and Stroke Council. Current Science on Consumer Use of Mobile Health for Cardiovascular Disease Prevention: A Scientific Statement From the American Heart Association. Circulation. 2015 Sep 22;132(12):1157-213. doi: 10.1161/CIR.0000000000000232. Epub 2015 Aug 13. No abstract available. Erratum In: Circulation. 2015 Nov 10;132(19):e233. doi: 10.1161/CIR.0000000000000335. PubMed 26271892 ↗
  • Piper ME, Cook JW, Schlam TR, Jorenby DE, Smith SS, Collins LM, Mermelstein R, Fraser D, Fiore MC, Baker TB. A Randomized Controlled Trial of an Optimized Smoking Treatment Delivered in Primary Care. Ann Behav Med. 2018 Sep 13;52(10):854-864. doi: 10.1093/abm/kax059. PubMed 30212849 ↗
  • Booth JN 3rd, Allen NB, Calhoun D, Carson AP, Deng L, Goff DC Jr, Redden DT, Reis JP, Shimbo D, Shikany JM, Sidney S, Spring B, Lewis CE, Muntner P. Racial Differences in Maintaining Optimal Health Behaviors Into Middle Age. Am J Prev Med. 2019 Mar;56(3):368-375. doi: 10.1016/j.amepre.2018.10.020. PubMed 30777156 ↗
  • Spring B, Pfammatter A, Alshurafa N. First Steps Into the Brave New Transdiscipline of Mobile Health. JAMA Cardiol. 2017 Jan 1;2(1):76-78. doi: 10.1001/jamacardio.2016.4440. No abstract available. PubMed 27973672 ↗
  • Hoffman SA, Ledford G, Cameron KA, Phillips SM, Pellegrini CA. A qualitative exploration of social and environmental factors affecting diet and activity in knee replacement patients. J Clin Nurs. 2019 Apr;28(7-8):1156-1163. doi: 10.1111/jocn.14719. Epub 2018 Dec 10. PubMed 30461097 ↗
  • Hekler EB, Michie S, Pavel M, Rivera DE, Collins LM, Jimison HB, Garnett C, Parral S, Spruijt-Metz D. Advancing Models and Theories for Digital Behavior Change Interventions. Am J Prev Med. 2016 Nov;51(5):825-832. doi: 10.1016/j.amepre.2016.06.013. PubMed 27745682 ↗
  • Kheirkhahan M, Tudor-Locke C, Axtell R, Buman MP, Fielding RA, Glynn NW, Guralnik JM, King AC, White DK, Miller ME, Siddique J, Brubaker P, Rejeski WJ, Ranshous S, Pahor M, Ranka S, Manini TM. Actigraphy features for predicting mobility disability in older adults. Physiol Meas. 2016 Oct;37(10):1813-1833. doi: 10.1088/0967-3334/37/10/1813. Epub 2016 Sep 21. PubMed 27653966 ↗
  • Collins LM, Kugler KC, Gwadz MV. Optimization of Multicomponent Behavioral and Biobehavioral Interventions for the Prevention and Treatment of HIV/AIDS. AIDS Behav. 2016 Jan;20 Suppl 1(0 1):S197-214. doi: 10.1007/s10461-015-1145-4. PubMed 26238037 ↗
  • Piper ME, Schlam TR, Cook JW, Smith SS, Bolt DM, Loh WY, Mermelstein R, Collins LM, Fiore MC, Baker TB. Toward precision smoking cessation treatment I: Moderator results from a factorial experiment. Drug Alcohol Depend. 2017 Feb 1;171:59-65. doi: 10.1016/j.drugalcdep.2016.11.025. Epub 2016 Nov 25. PubMed 28013098 ↗
  • Piper ME, Fiore MC, Smith SS, Fraser D, Bolt DM, Collins LM, Mermelstein R, Schlam TR, Cook JW, Jorenby DE, Loh WY, Baker TB. Identifying effective intervention components for smoking cessation: a factorial screening experiment. Addiction. 2016 Jan;111(1):129-41. doi: 10.1111/add.13162. Epub 2015 Nov 19. PubMed 26582269 ↗
  • Collins LM, Dziak JJ, Kugler KC, Trail JB. Factorial experiments: efficient tools for evaluation of intervention components. Am J Prev Med. 2014 Oct;47(4):498-504. doi: 10.1016/j.amepre.2014.06.021. Epub 2014 Aug 1. PubMed 25092122 ↗
  • Spring B, Pellegrini CA, Pfammatter A, Duncan JM, Pictor A, McFadden HG, Siddique J, Hedeker D. Effects of an abbreviated obesity intervention supported by mobile technology: The ENGAGED randomized clinical trial. Obesity (Silver Spring). 2017 Jul;25(7):1191-1198. doi: 10.1002/oby.21842. Epub 2017 May 11. PubMed 28494136 ↗
  • Pellegrini CA, Pfammatter AF, Conroy DE, Spring B. Smartphone applications to support weight loss: current perspectives. Adv Health Care Technol. 2015 Jul;1:13-22. doi: 10.2147/AHCT.S57844. PubMed 26236766 ↗
  • Spring B, Ockene JK, Gidding SS, Mozaffarian D, Moore S, Rosal MC, Brown MD, Vafiadis DK, Cohen DL, Burke LE, Lloyd-Jones D; American Heart Association Behavior Change Committee of the Council on Epidemiology and Prevention, Council on Lifestyle and Cardiometabolic Health, Council for High Blood Pressure Research, and Council on Cardiovascular and Stroke Nursing. Better population health through behavior change in adults: a call to action. Circulation. 2013 Nov 5;128(19):2169-76. doi: 10.1161/01.cir.0000435173.25936.e1. Epub 2013 Oct 7. No abstract available. PubMed 24100544 ↗
  • Baker TB, Collins LM, Mermelstein R, Piper ME, Schlam TR, Cook JW, Bolt DM, Smith SS, Jorenby DE, Fraser D, Loh WY, Theobald WE, Fiore MC. Enhancing the effectiveness of smoking treatment research: conceptual bases and progress. Addiction. 2016 Jan;111(1):107-16. doi: 10.1111/add.13154. Epub 2015 Nov 19. PubMed 26581974 ↗
  • Pellegrini CA, Hoffman SA, Daly ER, Murillo M, Iakovlev G, Spring B. Acceptability of smartphone technology to interrupt sedentary time in adults with diabetes. Transl Behav Med. 2015 Sep;5(3):307-14. doi: 10.1007/s13142-015-0314-3. PubMed 26327936 ↗
  • Piper ME, Cook JW, Schlam TR, Smith SS, Bolt DM, Collins LM, Mermelstein R, Fiore MC, Baker TB. Toward precision smoking cessation treatment II: Proximal effects of smoking cessation intervention components on putative mechanisms of action. Drug Alcohol Depend. 2017 Feb 1;171:50-58. doi: 10.1016/j.drugalcdep.2016.11.027. Epub 2016 Nov 24. PubMed 28013097 ↗
  • Schlam TR, Fiore MC, Smith SS, Fraser D, Bolt DM, Collins LM, Mermelstein R, Piper ME, Cook JW, Jorenby DE, Loh WY, Baker TB. Comparative effectiveness of intervention components for producing long-term abstinence from smoking: a factorial screening experiment. Addiction. 2016 Jan;111(1):142-55. doi: 10.1111/add.13153. Epub 2015 Nov 19. PubMed 26581819 ↗
  • Watkins E, Newbold A, Tester-Jones M, Javaid M, Cadman J, Collins LM, Graham J, Mostazir M. Implementing multifactorial psychotherapy research in online virtual environments (IMPROVE-2): study protocol for a phase III trial of the MOST randomized component selection method for internet cognitive-behavioural therapy for depression. BMC Psychiatry. 2016 Oct 6;16(1):345. doi: 10.1186/s12888-016-1054-8. PubMed 27716200 ↗
  • Collins LM, Nahum-Shani I, Almirall D. Optimization of behavioral dynamic treatment regimens based on the sequential, multiple assignment, randomized trial (SMART). Clin Trials. 2014 Aug;11(4):426-434. doi: 10.1177/1740774514536795. Epub 2014 Jun 5. PubMed 24902922 ↗
  • Cook JW, Collins LM, Fiore MC, Smith SS, Fraser D, Bolt DM, Baker TB, Piper ME, Schlam TR, Jorenby D, Loh WY, Mermelstein R. Comparative effectiveness of motivation phase intervention components for use with smokers unwilling to quit: a factorial screening experiment. Addiction. 2016 Jan;111(1):117-28. doi: 10.1111/add.13161. Epub 2015 Nov 19. PubMed 26582140 ↗
  • Pellegrini CA, Hoffman SA, Collins LM, Spring B. Optimization of remotely delivered intensive lifestyle treatment for obesity using the Multiphase Optimization Strategy: Opt-IN study protocol. Contemp Clin Trials. 2014 Jul;38(2):251-9. doi: 10.1016/j.cct.2014.05.007. Epub 2014 May 17. Erratum In: Contemp Clin Trials. 2015 Nov;45(Pt B):468-469. doi: 10.1016/j.cct.2015.09.001. PubMed 24846621 ↗
  • Pellegrini CA, Hoffman SA, Collins LM, Spring B. Corrigendum to "Optimization of remotely delivered intensive lifestyle treatment for obesity using the Multiphase Optimization Strategy: Opt-IN study protocol" [Contemp. Clin. Trials 38 (2014) 251-259]. Contemp Clin Trials. 2015 Nov;45(Pt B):468-469. doi: 10.1016/j.cct.2015.09.001. Epub 2015 Nov 29. No abstract available. PubMed 28802730 ↗
  • Spring B, Pfammatter AF, Marchese SH, Stump T, Pellegrini C, McFadden HG, Hedeker D, Siddique J, Jordan N, Collins LM. A Factorial Experiment to Optimize Remotely Delivered Behavioral Treatment for Obesity: Results of the Opt-IN Study. Obesity (Silver Spring). 2020 Sep;28(9):1652-1662. doi: 10.1002/oby.22915. Epub 2020 Jul 12. PubMed 32656994 ↗
  • Pfammatter AF, Marchese SH, Pellegrini C, Daly E, Davidson M, Spring B. Using the Preparation Phase of the Multiphase Optimization Strategy to Develop a Messaging Component for Weight Loss: Formative and Pilot Research. JMIR Form Res. 2020 May 13;4(5):e16297. doi: 10.2196/16297. PubMed 32347804 ↗

Study documents

  • Protocol and statistical analysis plan · Dec 20, 2018
  • Informed consent form · May 5, 2016

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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01814072
Lead sponsor
Northwestern University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Penn State University
Responsible party
Bonnie Spring (Professor, Northwestern University) — Principal investigator
First posted
Mar 19, 2013
Start date
Sep 2013
Primary completion
Sep 20, 2017
Completion
Sep 20, 2017
Results posted
Jan 5, 2021
Last update
Feb 1, 2023

Study contacts

Bonnie Spring, PhD
principal investigator · Northwestern University
Linda Collins, PhD
principal investigator · Penn State University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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