Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
FEMALE
ID05775497

Optimizing an Online Behavioral Weight Loss Program with Tailored Components for Sexual Minority Women: MOST Optimization Phase

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 affects sexual minority women, and behavioral weight loss programs are the standard treatment for mild to moderate obesity. Researchers developed an online behavioral weight loss program called Rx Weight Loss that is effective, low-cost, and scalable. To improve relevance and effectiveness, they created three new components tailored to address barriers common in sexual minority women: minority stress, low social support, and negative body image. This phase of the study aims to optimize these components using a factorial experiment with 88 women over six months. Participants will receive 12 weeks of the Rx Weight Loss program, which includes weekly online video lessons, self-monitoring of weight, calorie intake, and activity, plus personalized automated feedback. They will be randomized to receive 0 to 3 of the novel tailored components: a minority stress intervention teaching coping strategies, a social support intervention providing an online forum, and a negative body image intervention offering cognitive behavioral therapy skills. Each component consists of weekly 8-10 minute lessons delivered alongside the main program. During the study, participants will regularly submit data and engage with the online lessons and support platform. Researchers will measure changes in weight and the proportion achieving at least 5% weight loss at 6 months. They will also explore how the tailored components affect weight loss through mechanisms like stress coping and social support. The study includes safety monitoring and adherence encouragement through reminders. The overall goal is to finalize an optimized online behavioral obesity treatment tailored for 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

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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