Targeting Weight and Shape Concern Among Women with High Body Weight

Lifespan

Status: Active, not recruiting

Conditions: Weight Loss; Overweight and Obesity; Body Image Disturbance

Treatments: Behavioral: Facts about obesity, myths about weight loss; Behavioral: Modified Body Project; Behavioral: Lifestyle intervention for weight loss

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05845866

K23DK124578

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: Female

Ages: 25 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Modified Body Project

Experimental group

Description:

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

Treatment:

Behavioral: Lifestyle intervention for weight loss

Behavioral: Modified Body Project

Facts about obesity, myths about weight loss

Active Comparator group

Description:

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

Treatment:

Behavioral: Lifestyle intervention for weight loss

Behavioral: Facts about obesity, myths about weight loss