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

Phase 2

Completed

• Conditions: Weight Loss
• Interventions: Behavioral: 12 Telephone Coaching Sessions; Behavioral: 24 Telephone Coaching Sessions; Behavioral: Text Messages; Behavioral: Report to Primary Care Physician; Behavioral: Buddy Training; Behavioral: Recommendations to use meal replacements

• Registration Number: NCT01814072
• Lead Sponsor: Northwestern University

Brief 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.

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).

Study Timeline

• Study First Submitted: 2013-03-15
• Study First Submitted QC: 2013-03-15
• Study First Posted: 2013-03-19
• Study Start: 2013-09
• Primary Completion: 2017-09-20
• Study Completion: 2017-09-20
• Results First Submitted: 2020-12-09
• Results First Submitted QC: 2020-12-09
• Results First Posted: 2021-01-05
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 562

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Condition 19	Text Messages	1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars
Condition 1	12 Telephone Coaching Sessions	1) Lifestyle Core; 2) 12 Telephone Coaching Sessions; 3) Report to Primary Care Physician
Condition 20	12 Telephone Coaching Sessions	1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements
Condition 20	Text Messages	1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements
Condition 2	Buddy Training	1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements; 5) Buddy training via webinars
Condition 3	12 Telephone Coaching Sessions	1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars
Condition 4	12 Telephone Coaching Sessions	1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages
Condition 1	Report to Primary Care Physician	1) Lifestyle Core; 2) 12 Telephone Coaching Sessions; 3) Report to Primary Care Physician
Condition 2	12 Telephone Coaching Sessions	1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements; 5) Buddy training via webinars
Condition 4	Recommendations to use meal replacements	1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages
Condition 5	12 Telephone Coaching Sessions	1) Lifestyle Core; 2) 12 telephone sessions; 3) Buddy training via webinars
Condition 5	Buddy Training	1) Lifestyle Core; 2) 12 telephone sessions; 3) Buddy training via webinars
Condition 6	12 Telephone Coaching Sessions	1) Lifestyle Core; 2) 12 telephone coaching sessions; 3) Recommendations to use meal replacements
Condition 7	Text Messages	1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages
Condition 8	Text Messages	1) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars
Condition 9	24 Telephone Coaching Sessions	1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician
Condition 11	Buddy Training	1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars
Condition 12	Report to Primary Care Physician	1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages
Condition 14	Recommendations to use meal replacements	1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Recommendation to use meal replacements
Condition 4	Text Messages	1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages
Condition 3	Text Messages	1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars
Condition 8	12 Telephone Coaching Sessions	1) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars
Condition 12	24 Telephone Coaching Sessions	1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages
Condition 15	Text Messages	1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages
Condition 17	12 Telephone Coaching Sessions	1) Lifestyle Core; 2) 12 Telephone Coaching Sessions
Condition 2	Report to Primary Care Physician	1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements; 5) Buddy training via webinars
Condition 2	Recommendations to use meal replacements	1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements; 5) Buddy training via webinars
Condition 3	Report to Primary Care Physician	1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars
Condition 3	Buddy Training	1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars
Condition 8	Buddy Training	1) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars
Condition 10	Report to Primary Care Physician	1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Buddy training via webinars
Condition 11	Report to Primary Care Physician	1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars
Condition 12	Text Messages	1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages
Condition 12	Recommendations to use meal replacements	1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages
Condition 4	Report to Primary Care Physician	1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages
Condition 6	Recommendations to use meal replacements	1) Lifestyle Core; 2) 12 telephone coaching sessions; 3) Recommendations to use meal replacements
Condition 7	12 Telephone Coaching Sessions	1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages
Condition 8	Recommendations to use meal replacements	1) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars
Condition 9	Report to Primary Care Physician	1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician
Condition 10	Buddy Training	1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Buddy training via webinars
Condition 11	24 Telephone Coaching Sessions	1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars
Condition 11	Text Messages	1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars
Condition 14	24 Telephone Coaching Sessions	1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Recommendation to use meal replacements
Condition 15	24 Telephone Coaching Sessions	1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages
Condition 10	24 Telephone Coaching Sessions	1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Buddy training via webinars
Condition 10	Recommendations to use meal replacements	1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Buddy training via webinars
Condition 13	24 Telephone Coaching Sessions	1) Lifestyle Core; 2) 24 telephone sessions; 3) Buddy training via webinars
Condition 13	Buddy Training	1) Lifestyle Core; 2) 24 telephone sessions; 3) Buddy training via webinars
Condition 16	Text Messages	1) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars
Condition 24	Report to Primary Care Physician	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
Condition 24	Text Messages	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
Condition 24	Buddy Training	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
Condition 27	Buddy Training	1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars
Condition 28	Text Messages	1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements
Condition 31	Text Messages	1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages
Condition 16	24 Telephone Coaching Sessions	1) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars
Condition 18	12 Telephone Coaching Sessions	1) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendations to use meal replacements; 4) Buddy training via webinars
Condition 18	Recommendations to use meal replacements	1) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendations to use meal replacements; 4) Buddy training via webinars
Condition 18	Buddy Training	1) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendations to use meal replacements; 4) Buddy training via webinars
Condition 19	12 Telephone Coaching Sessions	1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars
Condition 20	Recommendations to use meal replacements	1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements
Condition 23	Report to Primary Care Physician	1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages
Condition 26	Buddy Training	1) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Buddy training via webinars
Condition 29	Report to Primary Care Physician	1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars
Condition 32	Text Messages	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
Condition 32	Recommendations to use meal replacements	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
Condition 16	Recommendations to use meal replacements	1) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars
Condition 19	Buddy Training	1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars
Condition 21	Report to Primary Care Physician	1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars
Condition 21	Buddy Training	1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars
Condition 23	12 Telephone Coaching Sessions	1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages
Condition 26	24 Telephone Coaching Sessions	1) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Buddy training via webinars
Condition 27	Text Messages	1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars
Condition 29	24 Telephone Coaching Sessions	1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars
Condition 16	Buddy Training	1) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars
Condition 23	Text Messages	1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages
Condition 24	12 Telephone Coaching Sessions	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
Condition 26	Recommendations to use meal replacements	1) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Buddy training via webinars
Condition 28	24 Telephone Coaching Sessions	1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements
Condition 29	Buddy Training	1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars
Condition 22	Report to Primary Care Physician	1) Lifestyle Core; 2) 12 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements
Condition 24	Recommendations to use meal replacements	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
Condition 25	24 Telephone Coaching Sessions	1) Lifestyle Core; 2) 24 telephone coaching sessions
Condition 27	24 Telephone Coaching Sessions	1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars
Condition 30	24 Telephone Coaching Sessions	1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements
Condition 30	Report to Primary Care Physician	1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements
Condition 31	Report to Primary Care Physician	1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages
Condition 32	24 Telephone Coaching Sessions	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
Condition 32	Report to Primary Care Physician	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
Condition 28	Recommendations to use meal replacements	1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements
Condition 30	Recommendations to use meal replacements	1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements
Condition 31	24 Telephone Coaching Sessions	1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages
Condition 32	Buddy Training	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

Primary Outcome Measures

Name	Time	Method
Weight Change (kg) From Baseline to Month 6, Main Effect of Time	From Baseline to Month 6	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).
Weight Change (kg) From Baseline to Month 6, Time by Factor Interaction	From Baseline to Month 6	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).

Secondary Outcome Measures

Name	Time	Method
Intervention for <$500	6 months	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.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States