Targeting Body Image Among Women of Higher Body Weight

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04810247
• Other study ID #: K23DK124578
• Status: Completed
• Phase: N/A
• Start date: January 4, 2021
• Est. completion date: May 19, 2022

Study information

• Verified date: May 2023
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 (i.e., 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 (e.g., 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 weight/shape-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 (n≤10). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 19, 2022
• Est. primary completion date: May 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• Female

• BMI between 25-40

• EDE-Q weight concern subscale>4

• EDE-Q shape concern subscale>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 delivery within 9 months

• No substance abuse disorder

• No weight loss medication or history of bariatric surgery

• No other weight loss program participation

Related Conditions & MeSH terms

• Body Image
• Body Weight
• Obesity
• Overweight

Intervention

Behavioral:
• Body Project
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.

Locations

Country	Name	City	State
United States	Weight Control and Diabetes Research Center	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EDE-Q Weight and Shape Concern	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.	4 weeks
Primary	Sociocultural Attitudes Towards Appearance Questionnaire-4	Internalized thin ideal is a subscale of the SATAQ-4. Scores can range from 1-5. Higher scores reflect greater internalized thin ideal	Baseline and 4 weeks
Primary	Weight Bias Internalization Scale	Internalized weight bias is calculated by taking the average value of the 10-item Weight Bias Internalization Scale (this excludes item 1 consistent with standards in the field). Possible scores range from 1-7. Higher scores reflect greater internalized weight bias.	Baseline and 4 weeks
Secondary	Momentary Weight and Shape Concern	Participants rated how negative their thoughts were about weight and shape since the previous prompt (on a 0-10 scale) 6 times per day for 7 days at baseline and following treatment. Individual participant responses were presented graphically and coded as representing a general decrease, increase, or no change in negative weight/shape-related thoughts from baseline to 4 weeks.	Baseline and four weeks
Secondary	Qualitative Feedback	Attendance at focus group. Following the four-week modified Body Project intervention, participants were asked to attend a meeting to provide feedback on their experience in the intervention.	within 4 weeks of intervention completion