Targeting Body Image Among Women of Higher Body Weight

NCT04810247 | Completed Results

• 1 other identifier: K23DK124578
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Obesity; Overweight; Body Image

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Momentary Weight and Shape Concern

  Baseline and four weeks

• Qualitative Feedback

  within 4 weeks of intervention completion

Study Arms (1)

Body Project intervention

EXPERIMENTAL

Behavioral: Body Project

Interventions

Body Project BEHAVIORAL

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.

Body Project intervention

Eligibility Criteria

• Age: 25 Years - 70 Years
• Gender Eligibility Details: The current study is limited to individuals who identify as female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Miriam Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Cohort 3 was discontinued by the PI due to low engagement. After the first group meeting, only 1 of 5 enrolled individuals was engaged/actively participating. Delivering the intervention one-on-one is not consistent with protocol and the group environment is conceptually an active ingredient of the intervention (and an important component per Focus Group feedback). Therefore, the study team decided to discontinue all study procedures for this group.

Results Point of Contact

• Title: Dr. KayLoni Olson
• Organization: The Miriam Hospital

kayloni.olson@lifespan.org

401-793-8971

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (Research)

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 22, 2021
• Study Start: January 4, 2021
• Primary Completion: May 19, 2022
• Study Completion: May 19, 2022
• Last Updated: June 1, 2023
• Results First Posted: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)