NCT05775497 · The Miriam Hospital
Optimizing an Online Behavioral Weight Loss Intervention and Novel Culturally Tailored Components for Sexual Minority Women
What this study 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.
View original scientific description
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.
Interventions
BEHAVIORAL
Behavioral weight loss intervention (Online; Rx Weight Loss)
Rx Weight Loss is a fully automated online behavioral obesity treatment that includes 3 core components: weekly online video lessons, submission of self-monitored weight, calorie intake, and activity data, and personalized automated feedback. Participants set goals for weight loss (e.g., 10%), daily calorie intake, and activity (e.g., 200 mins/week of moderate-to-vigorous intensity physical activity). Online lessons discuss healthy eating, physical activity, and behavioral skills (e.g., stimulus control, goal-setting, problem solving). To maintain participant engagement, lessons are interactive, use audio and video, and include experiential learning opportunities. Based on their progress, participants receive automated feedback that provides encouragement, praise for meeting goals, and constructive feedback. To enhance adherence, participants who do not view the weekly lesson or enter monitoring data receive e-mail reminders to re-engage.
BEHAVIORAL
Minority stress intervention
The Minority Stress Intervention will teach cognitive and behavioral strategies for coping with minority stress with a focus on how minority stress impacts weight loss behaviors. The treatment will primarily address stressors due to sexuality and weight but will also cover how minority stress intersects with other facets of identity. The intervention, while innovative, is adapted from evidence-based treatments using cognitive behavioral therapy (CBT) to address minority stress.Lessons will provide psychoeducation on minority stress related to sexuality, gender, and weight, how it intersects with other aspects of identity, and how it can interfere with weight loss (e.g., unhealthy eating, avoiding exercise and healthcare, reduced motivation, disengaging from the program).The treatment will be delivered in 12 8-10-min lessons/week (a duration comparable to previous treatments) viewed directly after Rx Weight Loss lessons in Wks 1-12.
BEHAVIORAL
Social support intervention
The Social Support Intervention will provide sexual minority women with online opportunities to give and receive real-time social support for weight loss efforts. The treatment is based on Social Learning Theory and evidence-based online social support programs used in behavioral weight loss. The intervention will include one video lesson outlining the value of social support for weight loss and well-being, strategies for eliciting support, and an orientation to using the online platform (hosted within Rx Weight Loss). The platform will feature a private forum where participants can post to provide support and discuss their weight loss goals, challenges, and successes. To foster engagement, discussion topics will be automated to post 4 times/week and those who do not participate will be reminded via e-mail to engage (1x/month).
BEHAVIORAL
Negative body image intervention
The Negative Body Image Intervention will teach CBT skills for improving negative body image and reducing its impact on weight loss behaviors. The treatment is derived from evidence-based CBT interventions targeting body image for women with obesity during behavioral weight loss and will be adapted to reflect the unique body image ideals and concerns of sexual minority women. Lessons will teach CBT strategies for coping with negative body image and reducing interference with weight loss efforts. The intervention will be delivered in 12 weekly 8-10-minute lessons, a treatment duration comparable to previous treatments and will be viewed immediately following Rx Weight Loss lessons during Weeks 1-12.
Primary outcome measures
Change in Weight
Time frame: 6 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 Weight
Time frame: 6 months
Mean weight loss at 6 months will be used to determine the proportion of participants who achieved clinically significant (5+%) weight loss.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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)).
Where
- Providence, Rhode Island
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 27, 2024 · Source of record for eligibility and locations