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Active, Not Recruiting

NCT Number: NCT05845866

Targeting Weight and Shape Concern Among Women with High Body Weight

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Body Image Disturbance Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

25 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

About this study

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:

  • To evaluate effects of a manualized intervention on Weight and Shape Concern prior to starting weight management.
  • To evaluate the effects of the modified Body Project intervention on momentary weight/shape-related thoughts and overeating episodes during behavioral weight management.
  • 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified Body Project

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.

Facts about obesity, myths about weight loss

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Overeating

    Time frame: week 16, week 28

    Ecological momentary assessment will be used to assess overeating in daily life.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 6, 2023
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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