An interventional study of Behavioral Weight Loss Intervention and Minority Stress Intervention in Obesity, sponsored by The Miriam Hospital. Completed at 1 site in United States. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-03-02.
Sponsored by The Miriam Hospital · Not applicable, Interventional, and Other
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.
6,578 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's enrollment of 28 is below the median of 77 across 5,084 interventional studies indexed under Obesity.
Browse Obesity studies →The Miriam Hospital is the lead sponsor of 182 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Participants complete an online behavioral weight loss program.
Behavioral: Behavioral Weight Loss 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.
Behavioral: Behavioral Weight Loss Intervention · Behavioral: 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.
Behavioral: Behavioral Weight Loss Intervention · Behavioral: Minority Stress Intervention · Behavioral: 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.
Behavioral: Behavioral Weight Loss Intervention · Behavioral: Minority Stress Intervention · Behavioral: Negative Body Image Intervention · Behavioral: 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.
Behavioral: Behavioral Weight Loss Intervention · Behavioral: Negative Body Image Intervention · Behavioral: 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.
Behavioral: Behavioral Weight Loss Intervention · Behavioral: Minority Stress Intervention · Behavioral: Social Support 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.
Behavioral: Behavioral Weight Loss Intervention · Behavioral: Negative Body Image 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.
Behavioral: Behavioral Weight Loss Intervention · Behavioral: Social Support 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.
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.
Also known as: Coping with Stress Program
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.
Also known as: Body Image Program
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.
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.
Time frame: Week 12 (post-treatment)
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — 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.
Ran from Jun 2021 to primary completion in Jun 2022, 12 months.
Of 2,253 non-industry interventional studies with no phase under Obesity, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's 12 months is below that.
Counting every sponsor, half of 2,351 studies reached it within 26 months; a quarter within 11 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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