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

Phase 2

Completed

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).

Recruitment & Eligibility

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:

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

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.