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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Behavioral Weight Loss Intervention; Behavioral: Minority Stress Intervention; Behavioral: Negative Body Image Intervention; Behavioral: Social Support Intervention

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Weight Control and Diabetes Research Center, The Miriam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Weight Loss Program Only; Participants complete an online behavioral weight loss program.	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.
Experimental: Weight Loss Program + Coping with Stress Program; Participants complete (1) an online behavioral weight loss program and (2) an adjunctive intervention that teaches strategies for coping with stress & stigma due to weight, sexual orientation, and gender & its impact on weight loss.	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.; Behavioral: 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.; Other Names: Coping with Stress Program
Experimental: Weight Loss Program + Coping with Stress Program + Body Image Program; Participants complete (1) an online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress & stigma due to weight, sexual orientation, and gender & its impact on weight loss, and (3) an adjunctive intervention for improving negative body image and reducing its impact on weight loss.	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.; Behavioral: 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.; Other Names: Coping with Stress Program; Behavioral: 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.; Other Names: Body Image Program
Experimental: Weight Loss Program + Coping with Stress Program + Body Image Program + Social Support Program; Participants complete (1) an online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress & stigma due to weight, sexual orientation, and gender & its impact on weight loss, (3) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts, and (4) an adjunctive intervention for improving negative body image and reducing its impact on weight loss.	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.; Behavioral: 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.; Other Names: Coping with Stress Program; Behavioral: 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.; Other Names: Body Image Program; Behavioral: 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.
Experimental: Weight Loss Program + Body Image Program + Social Support Program; Participants complete (1) an online behavioral weight loss program, (2) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts, and (3) an adjunctive intervention for improving negative body image and reducing its impact on weight loss.	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.; Behavioral: 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.; Other Names: Body Image Program; Behavioral: 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.
Experimental: Weight Loss Program + Coping with Stress Program + Social Support Program; Participants complete a (1) online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress & stigma due to weight, sexual orientation, and gender & its impact on weight loss, and (3) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts.	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.; Behavioral: 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.; Other Names: Coping with Stress Program; Behavioral: 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.
Experimental: Weight Loss Program + Body Image Program; Participants complete (1) an online behavioral weight loss program and (2) an adjunctive intervention for improving negative body image and reducing its impact on weight loss.	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.; Behavioral: 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.; Other Names: Body Image Program
Experimental: Weight Loss Program + Social Support Program; Participants complete (1) an online behavioral weight loss program and (2) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts.	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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): June 28, 2022
• Study Completion (Actual): June 28, 2022

Study Registration Dates

• First Submitted: August 30, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Weight loss; Sexual minority women; LGBTQ health
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss
• Other Study ID Numbers: 1550062; K23MD015092 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Data will be shared as follows:

• Results will be submitted to ClinicalTrials.gov within appropriate timelines.
• Quantitative data will be published in peer-reviewed manuscripts that will be submitted to PubMed Central upon acceptance.
• Study results will be presented to the scientific community at national conferences relevant to obesity and sexual minority health.
• Aggregate quantitative data may be requested from other researchers 5 years after the completion of the primary endpoint by contacting Dr. Panza. If there are no restrictions imposed by institutional policies, local IRBs, or laws/regulations, the investigators will make de-identified data available to a requester within the context of a clear data-sharing agreement Qualitative data will not be shared other than de-identified qualitative data that is published as part of peer-reviewed manuscripts.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No