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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Weight Loss

Intervention / Treatment
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* Behavioral: 12 Telephone Coaching Sessions
* Behavioral: 24 Telephone Coaching Sessions
* Behavioral: Report to Primary Care Physician
* Behavioral: Text Messages
* Behavioral: Recommendations to use meal replacements
* Behavioral: Buddy Training


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Condition 1<br>1) Lifestyle Core; 2) 12 Telephone Coaching Sessions; 3) Report to Primary Care Physician | Behavioral: 12 Telephone Coaching Sessions<br>* Participants will receive 12 telephone coaching sessions<br>Behavioral: Report to Primary Care Physician<br>* Participants will have a report detailing their weight loss progress sent to their primary care physician<br>|
| Experimental: Condition 2<br>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<br>* Participants will receive 12 telephone coaching sessions<br>Behavioral: Report to Primary Care Physician<br>* Participants will have a report detailing their weight loss progress sent to their primary care physician<br>Behavioral: Recommendations to use meal replacements<br>* Participants will receive recommendations from their coach to use meal replacements<br>Behavioral: Buddy Training<br>* Participants will have a buddy that will be trained via webinars to be a supportive buddy<br>|
| Experimental: Condition 3<br>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<br>* Participants will receive 12 telephone coaching sessions<br>Behavioral: Report to Primary Care Physician<br>* Participants will have a report detailing their weight loss progress sent to their primary care physician<br>Behavioral: Text Messages<br>* Participants will receive regular text messages<br>Behavioral: Buddy Training<br>* Participants will have a buddy that will be trained via webinars to be a supportive buddy<br>|
| Experimental: Condition 4<br>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<br>* Participants will receive 12 telephone coaching sessions<br>Behavioral: Report to Primary Care Physician<br>* Participants will have a report detailing their weight loss progress sent to their primary care physician<br>Behavioral: Text Messages<br>* Participants will receive regular text messages<br>Behavioral: Recommendations to use meal replacements<br>* Participants will receive recommendations from their coach to use meal replacements<br>|
| Experimental: Condition 5<br>1) Lifestyle Core; 2) 12 telephone sessions; 3) Buddy training via webinars | Behavioral: 12 Telephone Coaching Sessions<br>* Participants will receive 12 telephone coaching sessions<br>Behavioral: Buddy Training<br>* Participants will have a buddy that will be trained via webinars to be a supportive buddy<br>|
| Experimental: Condition 6<br>1) Lifestyle Core; 2) 12 telephone coaching sessions; 3) Recommendations to use meal replacements | Behavioral: 12 Telephone Coaching Sessions<br>* Participants will receive 12 telephone coaching sessions<br>Behavioral: Recommendations to use meal replacements<br>* Participants will receive recommendations from their coach to use meal replacements<br>|
| Experimental: Condition 7<br>1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages | Behavioral: 12 Telephone Coaching Sessions<br>* Participants will receive 12 telephone coaching sessions<br>Behavioral: Text Messages<br>* Participants will receive regular text messages<br>|
| Experimental: Condition 8<br>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<br>* Participants will receive 12 telephone coaching sessions<br>Behavioral: Text Messages<br>* Participants will receive regular text messages<br>Behavioral: Recommendations to use meal replacements<br>* Participants will receive recommendations from their coach to use meal replacements<br>Behavioral: Buddy Training<br>* Participants will have a buddy that will be trained via webinars to be a supportive buddy<br>|
| Experimental: Condition 9<br>1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician | Behavioral: 24 Telephone Coaching Sessions<br>* Participants will receive 24 telephone coaching sessions<br>Behavioral: Report to Primary Care Physician<br>* Participants will have a report detailing their weight loss progress sent to their primary care physician<br>|
| Experimental: Condition 10<br>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<br>* Participants will receive 24 telephone coaching sessions<br>Behavioral: Report to Primary Care Physician<br>* Participants will have a report detailing their weight loss progress sent to their primary care physician<br>Behavioral: Recommendations to use meal replacements<br>* Participants will receive recommendations from their coach to use meal replacements<br>Behavioral: Buddy Training<br>* Participants will have a buddy that will be trained via webinars to be a supportive buddy<br>|
| Experimental: Condition 11<br>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<br>* Participants will receive 24 telephone coaching sessions<br>Behavioral: Report to Primary Care Physician<br>* Participants will have a report detailing their weight loss progress sent to their primary care physician<br>Behavioral: Text Messages<br>* Participants will receive regular text messages<br>Behavioral: Buddy Training<br>* Participants will have a buddy that will be trained via webinars to be a supportive buddy<br>|
| Experimental: Condition 12<br>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<br>* Participants will receive 24 telephone coaching sessions<br>Behavioral: Report to Primary Care Physician<br>* Participants will have a report detailing their weight loss progress sent to their primary care physician<br>Behavioral: Text Messages<br>* Participants will receive regular text messages<br>Behavioral: Recommendations to use meal replacements<br>* Participants will receive recommendations from their coach to use meal replacements<br>|
| Experimental: Condition 13<br>1) Lifestyle Core; 2) 24 telephone sessions; 3) Buddy training via webinars | Behavioral: 24 Telephone Coaching Sessions<br>* Participants will receive 24 telephone coaching sessions<br>Behavioral: Buddy Training<br>* Participants will have a buddy that will be trained via webinars to be a supportive buddy<br>|
| Experimental: Condition 14<br>1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Recommendation to use meal replacements | Behavioral: 24 Telephone Coaching Sessions<br>* Participants will receive 24 telephone coaching sessions<br>Behavioral: Recommendations to use meal replacements<br>* Participants will receive recommendations from their coach to use meal replacements<br>|
| Experimental: Condition 15<br>1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages | Behavioral: 24 Telephone Coaching Sessions<br>* Participants will receive 24 telephone coaching sessions<br>Behavioral: Text Messages<br>* Participants will receive regular text messages<br>|
| Experimental: Condition 16<br>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<br>* Participants will receive 24 telephone coaching sessions<br>Behavioral: Text Messages<br>* Participants will receive regular text messages<br>Behavioral: Recommendations to use meal replacements<br>* Participants will receive recommendations from their coach to use meal replacements<br>Behavioral: Buddy Training<br>* Participants will have a buddy that will be trained via webinars to be a supportive buddy<br>|
| Experimental: Condition 17<br>1) Lifestyle Core; 2) 12 Telephone Coaching Sessions | Behavioral: 12 Telephone Coaching Sessions<br>* Participants will receive 12 telephone coaching sessions<br>|
| Experimental: Condition 18<br>1) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendations to use meal replacements; 4) Buddy training via webinars | Behavioral: 12 Telephone Coaching Sessions<br>* Participants will receive 12 telephone coaching sessions<br>Behavioral: Recommendations to use meal replacements<br>* Participants will receive recommendations from their coach to use meal replacements<br>Behavioral: Buddy Training<br>* Participants will have a buddy that will be trained via webinars to be a supportive buddy<br>|
| Experimental: Condition 19<br>1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars | Behavioral: 12 Telephone Coaching Sessions<br>* Participants will receive 12 telephone coaching sessions<br>Behavioral: Text Messages<br>* Participants will receive regular text messages<br>Behavioral: Buddy Training<br>* Participants will have a buddy that will be trained via webinars to be a supportive buddy<br>|
| Experimental: Condition 20<br>1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements | Behavioral: 12 Telephone Coaching Sessions<br>* Participants will receive 12 telephone coaching sessions<br>Behavioral: Text Messages<br>* Participants will receive regular text messages<br>Behavioral: Recommendations to use meal replacements<br>* Participants will receive recommendations from their coach to use meal replacements<br>|
| Experimental: Condition 21<br>1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars | Behavioral: Report to Primary Care Physician<br>* Participants will have a report detailing their weight loss progress sent to their primary care physician<br>Behavioral: Buddy Training<br>* Participants will have a buddy that will be trained via webinars to be a supportive buddy<br>|
| Experimental: Condition 22<br>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<br>* Participants will have a report detailing their weight loss progress sent to their primary care physician<br>|
| Experimental: Condition 23<br>1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages | Behavioral: 12 Telephone Coaching Sessions<br>* Participants will receive 12 telephone coaching sessions<br>Behavioral: Report to Primary Care Physician<br>* Participants will have a report detailing their weight loss progress sent to their primary care physician<br>Behavioral: Text Messages<br>* Participants will receive regular text messages<br>|
| Experimental: Condition 24<br>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<br>* Participants will receive 12 telephone coaching sessions<br>Behavioral: Report to Primary Care Physician<br>* Participants will have a report detailing their weight loss progress sent to their primary care physician<br>Behavioral: Text Messages<br>* Participants will receive regular text messages<br>Behavioral: Recommendations to use meal replacements<br>* Participants will receive recommendations from their coach to use meal replacements<br>Behavioral: Buddy Training<br>* Participants will have a buddy that will be trained via webinars to be a supportive buddy<br>|
| Experimental: Condition 25<br>1) Lifestyle Core; 2) 24 telephone coaching sessions | Behavioral: 24 Telephone Coaching Sessions<br>* Participants will receive 24 telephone coaching sessions<br>|
| Experimental: Condition 26<br>1) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Buddy training via webinars | Behavioral: 24 Telephone Coaching Sessions<br>* Participants will receive 24 telephone coaching sessions<br>Behavioral: Recommendations to use meal replacements<br>* Participants will receive recommendations from their coach to use meal replacements<br>Behavioral: Buddy Training<br>* Participants will have a buddy that will be trained via webinars to be a supportive buddy<br>|
| Experimental: Condition 27<br>1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars | Behavioral: 24 Telephone Coaching Sessions<br>* Participants will receive 24 telephone coaching sessions<br>Behavioral: Text Messages<br>* Participants will receive regular text messages<br>Behavioral: Buddy Training<br>* Participants will have a buddy that will be trained via webinars to be a supportive buddy<br>|
| Experimental: Condition 28<br>1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements | Behavioral: 24 Telephone Coaching Sessions<br>* Participants will receive 24 telephone coaching sessions<br>Behavioral: Text Messages<br>* Participants will receive regular text messages<br>Behavioral: Recommendations to use meal replacements<br>* Participants will receive recommendations from their coach to use meal replacements<br>|
| Experimental: Condition 29<br>1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars | Behavioral: 24 Telephone Coaching Sessions<br>* Participants will receive 24 telephone coaching sessions<br>Behavioral: Report to Primary Care Physician<br>* Participants will have a report detailing their weight loss progress sent to their primary care physician<br>Behavioral: Buddy Training<br>* Participants will have a buddy that will be trained via webinars to be a supportive buddy<br>|
| Experimental: Condition 30<br>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<br>* Participants will receive 24 telephone coaching sessions<br>Behavioral: Report to Primary Care Physician<br>* Participants will have a report detailing their weight loss progress sent to their primary care physician<br>Behavioral: Recommendations to use meal replacements<br>* Participants will receive recommendations from their coach to use meal replacements<br>|
| Experimental: Condition 31<br>1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages | Behavioral: 24 Telephone Coaching Sessions<br>* Participants will receive 24 telephone coaching sessions<br>Behavioral: Report to Primary Care Physician<br>* Participants will have a report detailing their weight loss progress sent to their primary care physician<br>Behavioral: Text Messages<br>* Participants will receive regular text messages<br>|
| Experimental: Condition 32<br>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<br>* Participants will receive 24 telephone coaching sessions<br>Behavioral: Report to Primary Care Physician<br>* Participants will have a report detailing their weight loss progress sent to their primary care physician<br>Behavioral: Text Messages<br>* Participants will receive regular text messages<br>Behavioral: Recommendations to use meal replacements<br>* Participants will receive recommendations from their coach to use meal replacements<br>Behavioral: Buddy Training<br>* Participants will have a buddy that will be trained via webinars to be a supportive buddy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | From Baseline to Month 6 | 
| 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). | From Baseline to Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months |