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

Lifespan

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Social Support Intervention; Behavioral: Negative Body Image Intervention; Behavioral: Minority Stress Intervention; Behavioral: Behavioral Weight Loss Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05036187

K23MD015092 (U.S. NIH Grant/Contract)

1550062

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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28 participants in 8 patient groups

Weight Loss Program Only

Experimental group

Description:

Participants complete an online behavioral weight loss program.

Treatment:

Behavioral: Behavioral Weight Loss Intervention

Weight Loss Program + Coping with Stress Program

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral Weight Loss Intervention

Behavioral: Minority Stress Intervention

Weight Loss Program + Coping with Stress Program + Body Image Program

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral Weight Loss Intervention

Behavioral: Negative Body Image Intervention

Behavioral: Minority Stress Intervention

Weight Loss Program + Coping with Stress Program + Body Image Program + Social Support Program

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral Weight Loss Intervention

Behavioral: Social Support Intervention

Behavioral: Negative Body Image Intervention

Behavioral: Minority Stress Intervention

Weight Loss Program + Body Image Program + Social Support Program

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral Weight Loss Intervention

Behavioral: Social Support Intervention

Behavioral: Negative Body Image Intervention

Weight Loss Program + Coping with Stress Program + Social Support Program

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral Weight Loss Intervention

Behavioral: Social Support Intervention

Behavioral: Minority Stress Intervention

Weight Loss Program + Body Image Program

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral Weight Loss Intervention

Behavioral: Negative Body Image Intervention

Weight Loss Program + Social Support Program

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral Weight Loss Intervention

Behavioral: Social Support Intervention