CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 46 enrolled
Drug / intervention
Body Projectbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04810247
NCT04810247N/ACompleted

Pilot Trial to Enhance Intervention Effects on Weight and Shape Concern Among Women With Higher Body Weight

The Miriam Hospital·interventional·Posted Mar 22, 2021·Updated Jun 1, 2023

In Brief

A clinical study evaluating Body Project for Obesity and 2 related conditions. Completed, enrolled 46 participants across 1 site.

Detailed Summary

The goal of this study is to modify the evidence-based Body Project intervention to more powerfully target weight and shape concern among women with BMI between 25-40 using exploratory sequential mixed methodology (using both quantitative and focus group data). Initial modifications to the intervention will be made to incorporate content targeting weight stigma and to ensure the materials are developmentally appropriate for adult women. Then a small group (n=5-10) of women with high weight and shape concern will receive the 4 week body project intervention; we will collect pre-post questionnaire data on weight and shape concern, thin ideal and weight stigma, and use ecological momentary assessment to examine in-the-moment thoughts about weight and shape. The body project intervention will then be revised using this information in combination with participant feedback elicited during a focus group session. The next iteration of the intervention will then be tested in another small group of n=5-10; it is estimated that it will take 4-6 iterations to achieve a more robust intervention program that is acceptable to the target sample. Subgroups (race/ethnicity, BMI class) will be evaluated to ensure suitability across groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMar 22, 2021
Enrollment StartJan 4, 2021
Primary CompletionMay 19, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.3 years ago

Interventions

Body Projectbehavioral

The Body project is a dissonance based intervention designed to target negative body image among adolescent females. The intervention is delivered in small groups of 5-10 individuals over 4, one-hour group sessions. This program will be iteratively revised for use among adult women with weight/shape concern and higher body weight.