Targeting Weight and Shape Concern Among Women with High Body Weight

March 25, 2025 updated by: The Miriam Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Weight Control and Diabetes Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female
  • Body Mass Index between 25-40
  • Eating Disorder Examination-Questionnaire weight concern subscale greater than or equal to 4
  • Eating Disorder Examination-Questionnaire shape concern subscale greater than or equal to 4.25
  • Personal use of cell phone
  • Able to engage in moderate intensity activity
  • Desire for weight loss

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modified Body Project
Participants will receive this four week intervention followed by 6 months of behavioral weight management
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: 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.
Active Comparator: Facts about obesity, myths about weight loss
Participants will receive this four week intervention followed by 6 months of behavioral weight management
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight and shape concern
Time Frame: week 4
Assessed using the weight concern and shape concern subscales of the Eating Disorder Examination-Questionnaire. Subscale scores range from 0-6.
week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Momentary Weight and Shape Concern
Time Frame: week 16, week 28
Ecological momentary assessment will be used to assess in-the-moment thoughts about weight and shape on a 0-10 scale.
week 16, week 28
Overeating
Time Frame: week 16, week 28
Ecological momentary assessment will be used to assess overeating in daily life.
week 16, week 28

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight change
Time Frame: week 4 to week 28
Percent weight change will be calculated from weight at the start of weight loss treatment to program completion.
week 4 to week 28
Adherence to lifestyle intervention
Time Frame: week 4 to week 28
Adherence to exercise, dietary tracking, and self-weighing will be monitored throughout weight loss treatment.
week 4 to week 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Miriam Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2023

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

April 26, 2023

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23DK124578 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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