Clinical trial NCT05036187: Refining Novel Culturally Tailored Behavioral Weight Loss Treatment Components for Sexual Minority Women With Obesity
Official title: Using the Multiphase Optimization Strategy to Optimize a Culturally Tailored Online Behavioral Weight Loss Intervention for Sexual Minority Women: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
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: 2021-09-05
Enrollment: 28
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: After a pre-piloting phase (consisting of initial content piloting, interviews, and intervention refinement; anticipated n=12), participants (anticipated n=8) will receive the online weight loss treatment and will be randomized to receive 0-3 novel intervention 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.

Enrollment for both the pre-piloting phases (anticipated n=12) and open pilot trial phase (anticipated n=8) are reported here.
Primary purpose: OTHER

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. 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.


Eligibility criteria: 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)).

Primary outcomes:
measure: Intervention Acceptability
timeFrame: Week 12 (post-treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Weight Control and Diabetes Research Center, The Miriam Hospital
state: Rhode Island
Study officials:
References: