Phase 3
Completed N=562
Opt-IN: Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity
Source: ClinicalTrials.gov NCT01814072 ↗Enrolled (actual)
562
Serious AEs
0.4%
Results posted
Jan 2021
Primary outcomePrimary: Weight Change (kg) From Baseline to Month 6, Main Effect of Time — -4.8 Kg — p=<.001
◆ Published Evidence
Established
68citations · ~11 / year
A Factorial Experiment to Optimize Remotely Delivered Behavioral Treatment for Obesity: Results of the Opt-IN 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.
Linked Publications (2)
-
A Factorial Experiment to Optimize Remotely Delivered Behavioral Treatment for Obesity: Results of the Opt-IN Study.
-
Using the Preparation Phase of the Multiphase Optimization Strategy to Develop a Messaging Component for Weight Loss: Formative and Pilot Research.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Change (kg) From Baseline to Month 6, Main Effect of Time |
-4.8 | <.001 sig |
| PRIMARY Weight Change (kg) From Baseline to Month 6, Time by Factor Interaction |
.1244; -.0226; .0840; .1081; -.4353 | 0.567 |
| SECONDARY Intervention for <$500 |
427 | 0.051 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01814072) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.