Cognitive Strategies for Weight Loss

Summary

The goal of this clinical trial is to compare weight change and other related outcomes associated with three different behavioral weight loss interventions (STANDARD Behavioral, PREVENT, and PROMOTE) in adults with obesity. The main questions it aims to answer are:

* Which of the three Internet-delivered weight loss programs results in the greatest weight loss?
* How do key weight-related behaviors (e.g., adherence, diet, physical activity) differ across the arms?
* What individual characteristics predict success in each arm?
* What are the underlying mechanisms of each approach?
* Are there any potential adverse outcomes associated with any of the conditions (e.g., depression, weight stigmatization, increased body image concerns).

Participants will:

* signed informed consent
* complete a baseline assessment
* be randomized to 12 months of either Standard iBWL, PREVENT or PROMOTE
* complete a training workshop to learn arm-specific cognitive strategies
* complete a 12-month Internet-delivered weight loss program, requiring self-monitoring of intake and exercise and viewing of 12 weekly lessons followed by 9 monthly lessons
* complete an assessment at 3 months (during treatment)
* complete a refresher workshop on arm-specific cognitive strategies at 3 months
* complete an assessment at 6 months (during treatment), 12 months (at the conclusion of treatment), and 18 months (6 months after treatment

Conditions

• Obesity

Interventions

BEHAVIORAL

Standard Behavioral Weight Loss Intervention

12-month online behavioral weight loss intervention

BEHAVIORAL

PREVENT Behavioral Weight Loss Intervention

12-month online behavioral weight loss intervention focused on preventing future negative consequences of obesity

BEHAVIORAL

PROMOTE Behavioral Weight Loss Intervention

12-month online behavioral weight loss intervention focused on promoting future benefits of maintaining a healthy weight

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Brown University

  collaborator OTHER

• University of Minnesota

  collaborator OTHER

• The Miriam Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-03-01

Primary Completion

2026-05-31

Completion

2026-08-31

Countries

• United States

Study Locations