Targeting Weight and Shape Concern Among Women With High Body Weight

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05845866
• Other study ID #: K23DK124578
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2023
• Source: The Miriam Hospital
• Contact: KayLoni Olson
• Phone: 401-793-8971
• Email: kayloni.olson[@]lifespan.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Image Disturbance
• Body Weight
• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Weight Control and Diabetes Research Center	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight change	Percent weight change will be calculated from weight at the start of weight loss treatment to program completion.	week 4 to week 28
Other	Adherence to lifestyle intervention	Adherence to exercise, dietary tracking, and self-weighing will be monitored throughout weight loss treatment.	week 4 to week 28
Primary	Weight and shape concern	Assessed using the weight concern and shape concern subscales of the Eating Disorder Examination-Questionnaire. Subscale scores range from 0-6.	week 4
Secondary	Momentary Weight and Shape Concern	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
Secondary	Overeating	Ecological momentary assessment will be used to assess overeating in daily life.	week 16, week 28