Clinical trial NCT04810247: Targeting Body Image Among Women of Higher Body Weight
Official title: Pilot Trial to Enhance Intervention Effects on Weight and Shape Concern Among Women With Higher Body Weight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Body Image
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-03-22
Enrollment: 46
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: EDE-Q Weight and Shape Concern
timeFrame: 4 weeks
measure: Sociocultural Attitudes Towards Appearance Questionnaire-4
timeFrame: Baseline and 4 weeks
measure: Weight Bias Internalization Scale
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Momentary Weight and Shape Concern
timeFrame: Baseline and four weeks
measure: Qualitative Feedback
timeFrame: within 4 weeks of intervention completion
Other outcomes:
Locations:
city: Providence
country: United States
facility: Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
References: