Targeting Body Image Among Women of Higher Body Weight

Sponsor
The Miriam Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04810247
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
60
1
1
16.9
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Body Project
N/A

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 (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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot Trial to Enhance Intervention Effects on Weight and Shape Concern Among Women With Higher Body Weight
Actual Study Start Date :
Jan 4, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Body Project intervention

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Eating Disorders Examination-Questionnaire [Change at 4-weeks]

    Weight and shape concern will be assessed with the Eating Disorders Examination-Questionnaire. This self-report measure is a 28-item scale that was translated from a clinician-delivered format to assess behavioral features of eating disorders including negative body image as experienced during the past 4-weeks. All items are answered on a 0-6 point scale reflecting either frequency or severity with higher scores reflecting greater symptoms. There are four subscales of this measure but the weight concern and shape concern subscales will be used for the current study. Each subscale is comprised of 8- items and 5-items respectively with potential mean values ranging from 0-6 on each.

  2. Sociocultural Attitudes Towards Appearance Questionnaire-4 [Change at 4-weeks]

    Internalization of the thin ideal will be assessed with the Sociocultural Attitudes Towards Appearance Questionnaire-4 or the SATAQ-4. The SATAQ-4 measures the degree to which an individual internalizes the current societally prescribed standards of attractiveness or beauty. The 22-item measure can be used to calculate an average of all items reflecting the total score as well as five subscales; thin ideal internalization, athletic-muscular internalization, pressure from family, pressure from the media, and pressure from peers. The thin ideal internalization subscale will be used for this study with potential scores ranging from 1-5 (higher scores reflect greater internalization of a thin body ideal.) This scale has demonstrated adequate to strong internal reliability as demonstrated by Cronbachs alpha=0.81 in previous samples of women with overweight or obesity.

  3. Weight bias internalization scale [Change at 4-weeks]

    Internalized weight bias will be assessed with the Weight Bias Internalization Scale. The WBIS is an 11- item questionnaire designed to assess the degree to which an individual believes negative weight-related attributes are accurate and applicable to him or herself. Consistent with current standards in the field, the first item will be excluded due to low inter-correlation. Potential scores can range from 1-7 with higher scores reflecting a greater degree of internalized weight bias.

Secondary Outcome Measures

  1. Momentary weight and shape concern [Change at 4-weeks]

    Negative weight and shape-related thoughts will be assessed on a momentary basis using EMA to evaluate the treatment effects of mBP on momentary features of WSC (negative thoughts) after treatment. Participants will be asked to rate how negative their thoughts were about weight and shape since the previous prompt (on a 0-10 scale) and to report cues for negative weight-related thoughts.

  2. Qualitative feedback [up to 4 weeks post intervention]

    Participants will attend a focus group with the women in their cohort to provide feedback on the intervention. This will be used to determine participants' understanding of key concepts targeted in the program. Change data from primary measures and EMA data will be used to shape the focus group script consistent with a sequential mixed methods design. Participants will be probed for additional contributors to negative body image and overall acceptability and satisfaction with intervention components. Directed content analysis will be used to evaluate the focus group using an a priori codebook based on theoretical models used to inform development of the body project intervention. Two coders will review the transcript. Discrepancies in coding will be reconciled between coders and emergent codes will be discussed until there is full agreement on the final coding.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Weight Control and Diabetes Research Center Providence Rhode Island United States 02903

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kayloni Olson, Assistant Professor (Research), The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT04810247
Other Study ID Numbers:
  • K23DK124578
First Posted:
Mar 22, 2021
Last Update Posted:
Apr 8, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2022