Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
FEMALE
NCT05775497

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

Led by The Miriam Hospital · Updated on 2024-12-27

88

Participants Needed

1

Research Sites

86 weeks

Total Duration

On this page

Sponsors

T

The Miriam Hospital

Lead Sponsor

N

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborating Sponsor

AI-Summary

What this Trial Is 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. 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Assigned female at birth and currently identify as female
  • Self-identify as a sexual minority (e.g., lesbian, bisexual)
  • Body mass index (BMI) between 25 and 50 kg/m2
  • Aged 18 to 70 years old
  • Interested in losing weight
  • Have regular internet and email access
  • No significant weight loss (>5%) in the past 6 months
  • 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
Not Eligible

You will not qualify if you...

  • Previously participated in a prior phase of this study
  • Report a serious mental or physical health condition that increases treatment risks, such as active psychosis, suicidality, mania, alcohol or substance use disorder
  • Have a serious, active, unstable, or degenerative medical condition (e.g., congestive heart failure)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Weight Control and Diabetes Research Center

Providence, Rhode Island, United States, 02903

Actively Recruiting

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Research Team

E

Emily Panza, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

8

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