NCT05845866

Targeting Weight and Shape Concern Among Women with High Body Weight

Randomized Controlled Pilot Trial Targeting Weight and Shape Concern Among Women Enrolled in Behavioral Weight Management

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The Miriam Hospital · Academic / Other
• Sex: Female
• Age: 25 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized controlled trial to evaluate the effect of an adapted version of the Body Project program among adult women of higher body weight who want to lose weight. The study will evaluate treatment effects on weight and shape concern and explore the impact of intervention on weight loss outcomes.

Detailed description

The objective of this study is to conduct a randomized controlled pilot trial to test the effects of a 28-week treatment protocol that combines a modified body image intervention (The Body Project: weeks 1-4) with a 6-month standard behavioral weight management treatment (weeks 5-28). The combined protocol will be evaluated in comparison to a control group that receives an education only program during weeks 1-4 followed by the same 6-month weight management treatment. It will be tested among women with high body weight who report High Weight and Shape Concern and would like to lose weight. The goals of the study are: 1. To evaluate effects of a manualized intervention on Weight and Shape Concern prior to starting weight management. 2. To evaluate the effects of the modified Body Project intervention on momentary weight/shape-related thoughts and overeating episodes during behavioral weight management. 3. To conduct exploratory analyses comparing effects of the two treatment conditions on weight loss and other weight-related behaviors (e.g., exercise, adherence to self-monitoring).

Conditions

• Body Image Disturbance
• Overweight and Obesity
• Weight Loss

Interventions

Type	Name	Description
BEHAVIORAL	Modified Body Project	The Body Project, an evidence-based body image intervention developed for young women at risk for eating pathology, was adapted for use among adult women with high weight and shape concern and high body weight who want to lose weight.
BEHAVIORAL	Facts about obesity, myths about weight loss	This intervention is designed to help individuals prepare for weight loss and is focused on facts about obesity, myths about weight loss, and the importance of a varied diet.
BEHAVIORAL	Lifestyle intervention for weight loss	This 24-week behavioral weight management program is based on the Look AHEAD and Diabetes Prevention Program manuals. It is designed to facilitate 7-10% weight loss of initial body weight through dietary and physical activity changes with use of behavioral strategies to support lifestyle changes over time.

Timeline

• Start date: 2023-08-21
• Primary completion: 2025-03-31
• Completion: 2025-08-31
• First posted: 2023-05-06
• Last updated: 2025-03-30

Locations

1 site across 1 country: United States