Using the Multiphase Optimization Strategy to Optimize a Culturally Tailored Online Behavioral Weight Loss Intervention for Sexual Minority Women: Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The Miriam Hospital
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Intervention Acceptability
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Other
- Masking
- None
Masking Description
There is no masking during the pilot phase where the goal is to improve the program's acceptability.
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)).
Arms & Interventions
Weight Loss Program Only
Participants complete an online behavioral weight loss program.
Intervention: Behavioral Weight Loss Intervention (Behavioral)
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.
Intervention: Behavioral Weight Loss Intervention (Behavioral)
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.
Intervention: Minority Stress Intervention (Behavioral)
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.
Intervention: Behavioral Weight Loss Intervention (Behavioral)
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.
Intervention: Minority Stress Intervention (Behavioral)
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.
Intervention: Negative Body Image Intervention (Behavioral)
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.
Intervention: Behavioral Weight Loss Intervention (Behavioral)
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.
Intervention: Minority Stress Intervention (Behavioral)
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.
Intervention: Negative Body Image Intervention (Behavioral)
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.
Intervention: Social Support Intervention (Behavioral)
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.
Intervention: Behavioral Weight Loss Intervention (Behavioral)
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.
Intervention: Negative Body Image Intervention (Behavioral)
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.
Intervention: Social Support Intervention (Behavioral)
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.
Intervention: Behavioral Weight Loss Intervention (Behavioral)
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.
Intervention: Minority Stress Intervention (Behavioral)
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.
Intervention: Social Support Intervention (Behavioral)
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.
Intervention: Behavioral Weight Loss Intervention (Behavioral)
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.
Intervention: Negative Body Image Intervention (Behavioral)
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.
Intervention: Behavioral Weight Loss Intervention (Behavioral)
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.
Intervention: Social Support Intervention (Behavioral)
Outcomes
Primary Outcomes
Intervention Acceptability
Time Frame: Week 12 (post-treatment)
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.
Secondary Outcomes
No secondary outcomes reported