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Optimizing an Online Behavioral Weight Loss Intervention and Novel Culturally Tailored Components for Sexual Minority Women

Not Applicable
Recruiting
Conditions
Obesity
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Primary Outcome Measures
NameTimeMethod
Proportion of Patients Achieving a Weight Loss of 5+% of Initial Weight6 months

Mean weight loss at 6 months will be used to determine the proportion of participants who achieved clinically significant (5+%) weight loss.

Change in Weight6 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.

Secondary Outcome Measures
NameTimeMethod
Change in negative body image3 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 Weight3 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 Weight3 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 stress3 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 support3 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

Weight Control and Diabetes Research Center
🇺🇸Providence, Rhode Island, United States
Emily Panza, PhD
Contact
401-793-9714
emily_panza@brown.edu

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