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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Behavioral Weight Loss Intervention
* Behavioral: Minority Stress Intervention
* Behavioral: Negative Body Image Intervention
* Behavioral: Social Support Intervention


Participation Criteria
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Eligibility Criteria
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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)).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: After a pre-piloting phase (consisting of initial content piloting, interviews, and intervention refinement; anticipated n=12), participants (anticipated n=8) will receive the online weight loss treatment and will be randomized to receive 0-3 novel intervention 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. Enrollment for both the pre-piloting phases (anticipated n=12) and open pilot trial phase (anticipated n=8) are reported here.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight Loss Program Only<br>Participants complete an online behavioral weight loss program. | Behavioral: Behavioral Weight Loss Intervention<br>* 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.<br>|
| Experimental: Weight Loss Program + Coping with Stress Program<br>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<br>* 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.<br>Behavioral: Minority Stress Intervention<br>* 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.<br>* Other names: Coping with Stress Program;|
| Experimental: Weight Loss Program + Coping with Stress Program + Body Image Program<br>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<br>* 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.<br>Behavioral: Minority Stress Intervention<br>* 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.<br>* Other names: Coping with Stress Program;Behavioral: Negative Body Image Intervention<br>* 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.<br>* Other names: Body Image Program;|
| Experimental: Weight Loss Program + Coping with Stress Program + Body Image Program + Social Support Program<br>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<br>* 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.<br>Behavioral: Minority Stress Intervention<br>* 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.<br>* Other names: Coping with Stress Program;Behavioral: Negative Body Image Intervention<br>* 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.<br>* Other names: Body Image Program;Behavioral: Social Support Intervention<br>* 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.<br>|
| Experimental: Weight Loss Program + Body Image Program + Social Support Program<br>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<br>* 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.<br>Behavioral: Negative Body Image Intervention<br>* 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.<br>* Other names: Body Image Program;Behavioral: Social Support Intervention<br>* 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.<br>|
| Experimental: Weight Loss Program + Coping with Stress Program + Social Support Program<br>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<br>* 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.<br>Behavioral: Minority Stress Intervention<br>* 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.<br>* Other names: Coping with Stress Program;Behavioral: Social Support Intervention<br>* 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.<br>|
| Experimental: Weight Loss Program + Body Image Program<br>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<br>* 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.<br>Behavioral: Negative Body Image Intervention<br>* 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.<br>* Other names: Body Image Program;|
| Experimental: Weight Loss Program + Social Support Program<br>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<br>* 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.<br>Behavioral: Social Support Intervention<br>* 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.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sexual minority women, LGBTQ health, Weight loss