Targeting Weight and Shape Concern Among Women with High Body Weight

Last updated: March 25, 2025
Sponsor: The Miriam Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Obesity

Weight Loss

Diabetes Prevention

Treatment

Lifestyle intervention for weight loss

Facts about obesity, myths about weight loss

Modified Body Project

Clinical Study ID

NCT05845866
K23DK124578
  • Ages 25-70
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female

  • Body Mass Index between 25-40

  • Eating Disorder Examination-Questionnaire weight concern subscale greater than orequal to 4

  • Eating Disorder Examination-Questionnaire shape concern subscale greater than orequal to 4.25

  • Personal use of cell phone

  • Able to engage in moderate intensity activity

  • Desire for weight loss

Exclusion

Exclusion Criteria:

  • No eating disorder history

  • Not pregnant

  • Not breastfeeding

  • No childbirth/delivery within 9 months

  • No substance use disorder

  • No weight loss medication or history of bariatric surgery

  • No other weight loss program participation

Study Design

Total Participants: 60
Treatment Group(s): 3
Primary Treatment: Lifestyle intervention for weight loss
Phase:
Study Start date:
August 21, 2023
Estimated Completion Date:
August 31, 2025

Study 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).

Connect with a study center

  • Weight Control and Diabetes Research Center

    Providence, Rhode Island 02903
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.