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NCT04810247 · ClinicalTrials.gov registry record · NA
Targeting Body Image Among Women of Higher Body Weight
A NA study of Obesity and Overweight, sponsored by The Miriam Hospital.
- Completed
- Registry status
- NA
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT04810247: Completed NA study of Obesity and Overweight, sponsored by The Miriam Hospital.
NCT04810247 is a NA study of Obesity and Overweight that has completed, run by The Miriam Hospital. The registered enrollment target is 46 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04810247, a NA study of Obesity and Overweight, has completed, sponsored by The Miriam Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Participants were eligible for the study if they reported a shape concern score greater than or equal to 4.25 and a weight concern score greater than or equal to 4.0. Clinically significant change in weight and shape concern was defined as no longer meeting study eligibility on just one subscale or on both subscale (shape concern score \<4.25; weight concern score \<4.0). This outcome reports the number of participants who met this clinical milestone and no longer met criteria for enrollment.
Conditions Studied
Interventions
- BEHAVIORAL Body Project
Study Locations (1)
Rhode Island
- Weight Control and Diabetes Research Center - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2021-01-04 |
| Est. Completion | 2022-05-19 |
| Phase | NA |
What the finished NCT04810247 record still lists
NCT04810247 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (94% lower).
The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which Body Project is the first listed.
NCT04810247 reports a single indexed study location in Rhode Island.
Frequently Asked Questions
What is clinical trial NCT04810247 about?
NCT04810247 is a clinical study titled "Targeting Body Image Among Women of Higher Body Weight". 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 intervent...
What is the current status of trial NCT04810247?
This trial is currently completed. It is a NA study. The enrollment target is 46 participants. The study started on 2021-01-04. Estimated completion is 2022-05-19.
What conditions does trial NCT04810247 study?
This clinical trial studies the following conditions: Obesity, Overweight, Body Image.
What interventions are being tested in trial NCT04810247?
The interventions under investigation include: Body Project (BEHAVIORAL).
Who is sponsoring clinical trial NCT04810247?
This trial is sponsored by The Miriam Hospital, which has 136 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04810247 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04810247's enrollment target sits among peer trials
46 743rd of 1053 higher than 303 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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