Optimizing an Online Behavioral Weight Loss Intervention and Novel Culturally Tailored Components for Sexual Minority Women
- Conditions
- Obesity
- Interventions
- Behavioral: Behavioral weight loss intervention (Online; Rx Weight Loss)Behavioral: Minority stress interventionBehavioral: Social support interventionBehavioral: Negative body image intervention
- Registration Number
- NCT05775497
- Lead Sponsor
- The Miriam Hospital
- 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. In the Preparation Phase of this K23, the investigators developed 3 novel treatment components targeting sexual minority women's weight loss barriers (i.e., minority stress, low social support, and negative body image), the investigators piloted the program among sexual minority women of higher weight, and the investigators conducted individual qualitative interviews to elicit feedback on the intervention's acceptability, cultural relevance, usability, and feasibility, and this feedback was used to refine the program.
In the Optimization Phase of this K23 (the current phase), 88 women will receive 12 weeks of Rx Weight Loss and will be randomized to receive 0-3 tailored components in a full factorial design with 23 (8) distinct combinations of components. Novel components that increase mean weight loss (by ≥2%) or the proportion of women achieving clinically meaningful weight loss (by ≥10%) at 6 months will be retained in a finalized obesity treatment package that the investigators will evaluate in a future randomized controlled trial (RCT) (Evaluation Phase). The aims of this study are to:
Aim 2A (Optimization): Use a factorial experiment to determine how 3 novel components impact mean weight loss and the proportion of women achieving a 5+% weight loss at 6 months.
Aim 2B (Mediation): Clarify how tailored components impact weight loss by testing hypothesized mechanisms of action (i.e., coping with stress, perceived social support, weight and shape concerns).
This project will tailor and optimize an evidence-based online behavioral obesity treatment to enhance weight loss outcomes in sexual minority women.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 88
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Weight Loss Program Only Behavioral weight loss intervention (Online; Rx Weight Loss) Participants complete an online behavioral weight loss program. Weight Loss Program + Coping with Stress Program Minority stress intervention 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. Weight Loss Program + Coping with Stress Program + Body Image Program + Social Support Program Minority stress intervention 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. Weight Loss Program + Coping with Stress Program Behavioral weight loss intervention (Online; Rx Weight Loss) 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. Weight Loss Program + Coping with Stress Program + Body Image Program Behavioral weight loss intervention (Online; Rx Weight Loss) 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. Weight Loss Program + Coping with Stress Program + Body Image Program Minority stress intervention 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. Weight Loss Program + Body Image Program + Social Support Program Behavioral weight loss intervention (Online; Rx Weight Loss) 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. Weight Loss Program + Body Image Program + Social Support Program Negative body image intervention 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. Weight Loss Program + Social Support Program Social support intervention 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. Weight Loss Program + Coping with Stress Program + Body Image Program Negative body image intervention 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. Weight Loss Program + Body Image Program Negative body image intervention 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. Weight Loss Program + Coping with Stress Program + Body Image Program + Social Support Program Behavioral weight loss intervention (Online; Rx Weight Loss) 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. Weight Loss Program + Coping with Stress Program + Social Support Program Minority stress intervention 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. Weight Loss Program + Coping with Stress Program + Body Image Program + Social Support Program Social support intervention 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. Weight Loss Program + Coping with Stress Program + Body Image Program + Social Support Program Negative body image intervention 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. Weight Loss Program + Body Image Program + Social Support Program Social support intervention 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. Weight Loss Program + Coping with Stress Program + Social Support Program Behavioral weight loss intervention (Online; Rx Weight Loss) 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. Weight Loss Program + Body Image Program Behavioral weight loss intervention (Online; Rx Weight Loss) 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. Weight Loss Program + Social Support Program Behavioral weight loss intervention (Online; Rx Weight Loss) 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. Weight Loss Program + Coping with Stress Program + Social Support Program Social support intervention 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.
- Primary Outcome Measures
Name Time Method Change in Weight 6 months Body weight will be formally assessed by an RA at baseline, 3 months, and 6 months. Mean weight loss from baseline will be calculated.
Proportion of Patients Achieving a Weight Loss of 5+% of Initial Weight 6 months Mean weight loss at 6 months will be used to determine the proportion of participants who achieved clinically significant (5+%) weight loss.
- Secondary Outcome Measures
Name Time Method Change in negative body image 3 and 6 months after baseline Negative body image will be measured with the widely used weight and shape concern subscales of the Eating Disorder Examination Questionnaire. 8 items assess shape concerns and 5 items assess weight concerns on a 0 (not at all) to 6 (markedly) scale.
Change in Weight 3 months Body weight will be formally assessed by an RA at baseline, 3 months, and 6 months. Mean weight loss from baseline will be calculated.
Proportion of Patients Achieving a Weight Loss of 5+% of Initial Weight 3 months Mean weight loss at 3 months will be used to determine the proportion of participants who achieved clinically significant (5+%) weight loss.
Change in skills for coping with stress 3 and 6 months after baseline Skills for coping with stress will be measured with the 28-item Brief COPE Scale. This widely used scale assesses adaptive and maladaptive strategies for coping with stress using 14 subscales on a 1 (I havent been doing this at all) to 4 (Ive been doing this a lot) scale. Higher scores represent more frequent coping skill use.
Change in perceived social support 3 and 6 months after baseline Perceived social support will be measured with the 16-item Social Support Behaviors Scale (SSB), which assesses emotional, instrumental, and sexuality-specific social support on a 1-5 scale. Higher scores indicate more support. The SSB shows excellent internal consistency and validity in studies of SGM adults
Trial Locations
- Locations (1)
Weight Control and Diabetes Research Center
🇺🇸Providence, Rhode Island, United States