Clinical trial NCT05845866: Targeting Weight and Shape Concern Among Women with High Body Weight
Official title: Randomized Controlled Pilot Trial Targeting Weight and Shape Concern Among Women Enrolled in Behavioral Weight Management
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Body Image Disturbance
Overweight and Obesity
Weight Loss
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-05-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Weight and shape concern
timeFrame: week 4
Secondary outcomes:
measure: Momentary Weight and Shape Concern
timeFrame: week 16, week 28
measure: Overeating
timeFrame: week 16, week 28
Other outcomes:
measure: Weight change
timeFrame: week 4 to week 28
measure: Adherence to lifestyle intervention
timeFrame: week 4 to week 28
Locations:
city: Providence
country: United States
facility: Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
References: