Targeting Weight and Shape Concern Among Women with High Body Weight

NCT ID: NCT05845866

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-21

Study Completion Date

2025-08-31

Brief Summary

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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

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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

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Body Image Disturbance Overweight and Obesity Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Modified Body Project

Participants will receive this four week intervention followed by 6 months of behavioral weight management

Group Type EXPERIMENTAL

Modified Body Project

Intervention Type BEHAVIORAL

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.

Lifestyle intervention for weight loss

Intervention Type BEHAVIORAL

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.

Facts about obesity, myths about weight loss

Participants will receive this four week intervention followed by 6 months of behavioral weight management

Group Type ACTIVE_COMPARATOR

Facts about obesity, myths about weight loss

Intervention Type BEHAVIORAL

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.

Lifestyle intervention for weight loss

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

The Miriam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Weight Control and Diabetes Research Center

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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K23DK124578

Identifier Type: NIH

Identifier Source: org_study_id

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