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Targeting Weight and Shape Concern Among Women with High Body Weight

Not Applicable
Active, not recruiting
Conditions
Body Image Disturbance
Overweight and Obesity
Weight Loss
Interventions
Behavioral: Modified Body Project
Behavioral: Facts about obesity, myths about weight loss
Behavioral: Lifestyle intervention for weight loss
Registration Number
NCT05845866
Lead Sponsor
The Miriam Hospital
Brief 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.

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).

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
Female
Target Recruitment
60
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Facts about obesity, myths about weight lossLifestyle intervention for weight lossParticipants will receive this four week intervention followed by 6 months of behavioral weight management
Modified Body ProjectModified Body ProjectParticipants will receive this four week intervention followed by 6 months of behavioral weight management
Modified Body ProjectLifestyle intervention for weight lossParticipants will receive this four week intervention followed by 6 months of behavioral weight management
Facts about obesity, myths about weight lossFacts about obesity, myths about weight lossParticipants will receive this four week intervention followed by 6 months of behavioral weight management
Primary Outcome Measures
NameTimeMethod
Weight and shape concernweek 4

Assessed using the weight concern and shape concern subscales of the Eating Disorder Examination-Questionnaire. Subscale scores range from 0-6.

Secondary Outcome Measures
NameTimeMethod
Momentary Weight and Shape Concernweek 16, week 28

Ecological momentary assessment will be used to assess in-the-moment thoughts about weight and shape on a 0-10 scale.

Overeatingweek 16, week 28

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

Trial Locations

Locations (1)

Weight Control and Diabetes Research Center

🇺🇸

Providence, Rhode Island, United States

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