Randomized Controlled Pilot Trial Targeting Weight and Shape Concern Among Women Enrolled in Behavioral Weight Management
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- The Miriam Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Weight and shape concern
Study Overview
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:
- 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Arms & Interventions
Modified Body Project
Participants will receive this four week intervention followed by 6 months of behavioral weight management
Intervention: Modified Body Project (Behavioral)
Modified Body Project
Participants will receive this four week intervention followed by 6 months of behavioral weight management
Intervention: Lifestyle intervention for weight loss (Behavioral)
Facts about obesity, myths about weight loss
Participants will receive this four week intervention followed by 6 months of behavioral weight management
Intervention: Facts about obesity, myths about weight loss (Behavioral)
Facts about obesity, myths about weight loss
Participants will receive this four week intervention followed by 6 months of behavioral weight management
Intervention: Lifestyle intervention for weight loss (Behavioral)
Outcomes
Primary Outcomes
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
- Momentary Weight and Shape Concern(week 16, week 28)
- Overeating(week 16, week 28)