Refining Novel Culturally Tailored Behavioral Weight Loss Treatment Components for Sexual Minority Women With Obesity

Obesity Clinical Trial

Official title:

Using the Multiphase Optimization Strategy to Optimize a Culturally Tailored Online Behavioral Weight Loss Intervention for Sexual Minority Women: Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05036187
• Other study ID #: 1550062
• Secondary ID: K23MD015092
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: June 28, 2022

Study information

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

Clinical Trial Summary

Obesity disproportionately impacts sexual minority women. Behavioral weight loss programs are the gold standard treatment for mild to moderate obesity. The investigators have developed an online behavioral weight loss program that is effective, low-cost, and highly scalable. However, existing research suggests that tailoring treatment to address 3 well-established weight loss barriers in sexual minority women will be critical for maximizing the relevance and efficacy of behavioral weight loss for this group. The goal of the first phase of this K23 is to develop 3 novel treatment components targeting sexual minority women's weight loss barriers (i.e., minority stress, low social support, and negative body image), to pilot the program in sexual minority women with overweight/obesity, and to conduct individual qualitative interviews to elicit feedback on the intervention's acceptability, cultural relevance, usability, and feasibility that will be used to refine the program. After a pre-piloting phase (consisting of initial content piloting, interviews, and intervention refinement; anticipated n=12), 8 participants will pilot the full 3-month weight loss program and will be randomized to pilot 0-3 novel tailored components (targeting minority stress, negative body image, and social support) over the 3-month period. Participants will complete quantitative and qualitative assessments of intervention acceptability and appropriateness post-treatment and the intervention will be refined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 28, 2022
• Est. primary completion date: June 28, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Assigned female at birth and currently identify as female
• Self-identify a minority sexual orientation (e.g.,lesbian, bisexual)
• BMI>25kg/m2
• 18-70 years old
• Interested in losing weight
• Regular internet and e-mail access
• Fluent in English

Exclusion Criteria:

• Significant weight loss within past 6 months (>5%)
• Unable to participate in moderate physical activity
• Currently enrolled in a weight loss program
• Currently taking weight-loss medication
• Currently pregnant or trying to get pregnant
• Participated in a previous Phase of this study
• Reports a serious mental/physical health condition that would increase potential risks of treatment to the participant (e.g., active symptoms of psychosis, suicidality, mania, alcohol/substance use, or a medical condition that is serious, active, unstable, and degenerative (e.g., CHF)).

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Behavioral Weight Loss Intervention
Rx Weight Loss: PRIDE is a fully automated online behavioral obesity treatment that is tailored for sexual minority women and involves viewing 12 online video lessons delivered each week, self-monitoring body weight, calorie intake, and physical activity levels, and receiving personalized automated weekly feedback on progress toward goals.
• Minority Stress Intervention
The Minority Stress Intervention is designed to help sexual minority women cope with stress and stigma (e.g., due to weight, sexual orientation, gender). In this program, participants watch online video lessons that teach cognitive and behavioral strategies for coping with minority stress so that it may have less of an influence on participants' weight and well-being.
• Negative Body Image Intervention
The Negative Body Image Intervention is designed to help participants improve their body image. In this program, participants will watch online video lessons that provide education on queer women's body image and teach cognitive and behavioral strategies for improving your body image (regardless of your weight) to reduce its influence on your health.
• Social Support Intervention
The Social Support Intervention provides online opportunities for participants to receive more social support as they work toward their weight loss goals. Participants receive education on the importance of social support for weight management, they can earn badges for completing program milestones, and they gain access to a private online forum to get support and advice from other participants.

Locations

Country	Name	City	State
United States	Weight Control and Diabetes Research Center, The Miriam Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention Acceptability	A measure of intervention acceptability adapted from the Acceptability of Intervention (AIM) measure will assess acceptability outcomes post-treatment. Qualitative data on intervention acceptability and cultural appropriateness will also be considered.	Week 12 (post-treatment)