Clinical trial NCT05775497: Optimizing an Online Behavioral Weight Loss Intervention and Novel Culturally Tailored Components for Sexual Minority Women
Official title: Optimizing an Online Behavioral Weight Loss Intervention and Novel Culturally Tailored Components for Sexual Minority Women: MOST Optimization Phase
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Sexual minority women
LGBTQ health
Weight loss
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-03-20
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Participants (anticipated n=88) will receive the 12-week online weight loss treatment and will be randomized to receive 0-3 novel intervention components (targeting minority stress, negative body image, and social support). The primary outcome (weight loss) will be assessed at baseline, post-treatment (12 weeks), and follow-up (24 weeks).
Primary purpose: TREATMENT

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.


Eligibility criteria: * Assigned female at birth and currently identify as female
* Self-identify a minority sexual orientation (e.g.,lesbian, bisexual)
* BMI=25-50kg/m2
* 18-70 years old
* Interested in losing weight
* Regular internet and e-mail access
* No significant weight loss within past 6 months (\>5%)
* Fluent in English
* Able to participate in moderate physical activity
* Not currently enrolled in a weight loss program
* Not currently taking weight-loss medication
* Not 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)).

Primary outcomes:
measure: Change in Weight
timeFrame: 6 months
measure: Proportion of Patients Achieving a Weight Loss of 5+% of Initial Weight
timeFrame: 6 months
Secondary outcomes:
measure: Change in Weight
timeFrame: 3 months
measure: Proportion of Patients Achieving a Weight Loss of 5+% of Initial Weight
timeFrame: 3 months
measure: Change in skills for coping with stress
timeFrame: 3 and 6 months after baseline
measure: Change in perceived social support
timeFrame: 3 and 6 months after baseline
measure: Change in negative body image
timeFrame: 3 and 6 months after baseline
Other outcomes:
measure: Adherence to behavioral weight loss - Online metrics
timeFrame: 3 months after baseline
measure: Adherence to behavioral weight loss - Energy intake
timeFrame: 3 months after baseline
measure: Adherence to behavioral weight loss - Physical activity
timeFrame: 3 and 6 months after baseline
Locations:
city: Providence
country: United States
facility: Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
References: