Phase 3 N=384 Randomized Double-blind Treatment

Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy

Overweight and Obesity

Bottom Line

View on ClinicalTrials.gov: NCT04520256 ↗

Enrolled (actual)

384

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: Weight Change (Percent of Initial Body Weight) From Baseline to Month 12, Main Effect of Time — -5.8 percent of initial body weight — p=<.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Online Behavioral Weight Loss Program (Behavioral); Virtual Reality for Behavioral Weight Loss Skills Training (Behavioral); Tailored Interactive Video Feedback (Behavioral); Tailored Intervention for Structured Physical Activity (Behavioral); Skills Training for Dysregulated Eating (Behavioral); Platform for Social Support & Friendly Competition (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Miriam Hospital
Primary completion: May 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Weight Change (Percent of Initial Body Weight) From Baseline to Month 12, Main Effect of Time	-5.8	<.001 sig
PRIMARY Weight Change (Percent of Initial Body Weight) From Baseline to Month 12, Time by Intervention Component Interaction	-0.27; 0.09; -0.03; 0.44; 0.92	0.693
PRIMARY Proportion of Participants With Weight Loss ≥ 5% at Month 12, Main Effect of Time	0.08	0.999
PRIMARY Proportion of Participants With Weight Loss ≥ 5% at Month 12, Time by Intervention Component Interaction	.12; .15; .11; .11; .10	.999

Summary

When delivered online, behavioral obesity treatments have the potential to reach large numbers of individuals with overweight/obesity and produce significant improvements in health and wellbeing. In order to maximize the public health benefit of disseminating these treatments online, this study will use the Multiphase Optimization Strategy (MOST) framework to most quickly and efficiently determine which, if any, of 5 innovative intervention components, alone or in combination, increases the proportion of patients achieving a ≥5% weight loss, and mean weight loss, after a 12-month online behavioral obesity treatment.

Eligibility Criteria

English language fluent and literate at the 6th grade level
Body mass index (BMI) between 25 and 50 kg/m-squared
Able to walk 2 city blocks without stopping
Not currently participating in another weight loss program
Not currently taking weight loss medication
Has not lost ≥5% of body weight in the 6 months prior to enrolling
Has not been pregnant within the 6 months prior to enrolling
Does not plan to become pregnant within 12 months of enrolling
Denies having a heart condition, chest pain during periods of activity or rest, or loss of consciousness in the 12 months prior to enrolling
Denies any medical condition that would affect the safety of participating in unsupervised physical activity
Denies any condition that would result in inability to follow the study protocol, including terminal illness, substance abuse, eating disorder (not including Binge Eating Disorder) and untreated major psychiatric illness

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04520256). 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.