Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04810247
Status:
COMPLETED
Last Update Posted:
2023-06-01
First Post:
2021-03-17
Brief Title:
Targeting Body Image Among Women of Higher Body Weight
Sponsor:
The Miriam Hospital
Organization:
The Miriam Hospital
Study Overview
Official Title:
Pilot Trial to Enhance Intervention Effects on Weight and Shape Concern Among Women With Higher Body Weight
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 n5-10 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 n5-10 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 raceethnicity BMI class will be evaluated to ensure suitability across groups
Detailed Description:
Women with overweight or obesity over the age of 25 who report high weight and shape concern and a desire to lose weight will be recruited from the community Participants will be recruited and enrolled in cohorts of 5-10 individuals with a focus on ensuring that each group has approximately 50 women of color ie identify as non-white
Participants will attend with all individuals in their cohort the four weekly body project intervention sessions led by a trained facilitator Each session is approximately 60 minutes long and relies on guided discussion and group activities to engage participants In between group meetings participants will be given exercises to complete prior to the next session The intervention content will be modified prior to the first cohort in order to identify factors relevant for body image among women who would medically benefit from weight loss eg internalized weight bias The active ingredients will remain the same while modifying content and assignments or exercises to enhance effects among the target population
Participants will complete a baseline assessment of self-report surveys and a 7-day ecological momentary assessment period All assessment procedures must be complete prior to the first group meeting After the fourth and final group meeting participants will complete a second assessment including self-report surveys and a 7-day EMA period The data collected from the pre and post-assessments will be used to shape the focus group script Within four weeks of the last group meeting participants will attend a focus group meeting led by a facilitator who was not involved in intervention delivery to better understand the participant experience with the intervention content Key changes may include expanding content to address contextual factors that cause negative weightshape-related thoughts among women with overweight or obesity and to target weight stigma internalized modifying exercises that were reviewed negatively and incorporating explicit discussion of weight management
Following the focus group the intervention will be revised using the quantitative and qualitative data collected from each cohort The process will be repeated to refine the intervention through iterative testing with small groups of individuals n10 It is anticipated that approximately 4-6 groups will be required Upon completion of all study procedures participants will receive information and resources for healthy weight loss
Participants will attend with all individuals in their cohort the four weekly body project intervention sessions led by a trained facilitator Each session is approximately 60 minutes long and relies on guided discussion and group activities to engage participants In between group meetings participants will be given exercises to complete prior to the next session The intervention content will be modified prior to the first cohort in order to identify factors relevant for body image among women who would medically benefit from weight loss eg internalized weight bias The active ingredients will remain the same while modifying content and assignments or exercises to enhance effects among the target population
Participants will complete a baseline assessment of self-report surveys and a 7-day ecological momentary assessment period All assessment procedures must be complete prior to the first group meeting After the fourth and final group meeting participants will complete a second assessment including self-report surveys and a 7-day EMA period The data collected from the pre and post-assessments will be used to shape the focus group script Within four weeks of the last group meeting participants will attend a focus group meeting led by a facilitator who was not involved in intervention delivery to better understand the participant experience with the intervention content Key changes may include expanding content to address contextual factors that cause negative weightshape-related thoughts among women with overweight or obesity and to target weight stigma internalized modifying exercises that were reviewed negatively and incorporating explicit discussion of weight management
Following the focus group the intervention will be revised using the quantitative and qualitative data collected from each cohort The process will be repeated to refine the intervention through iterative testing with small groups of individuals n10 It is anticipated that approximately 4-6 groups will be required Upon completion of all study procedures participants will receive information and resources for healthy weight loss
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None