Recruiting

Behavioral Weight Loss

Sponsor:

The Miriam Hospital

Code:

NCT05775497

Conditions

Obesity

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Behavioral weight loss intervention (Online; Rx Weight Loss)

Minority stress intervention

Social support intervention

Negative body image intervention

Study Details

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.

Conditions

Obesity

Study ID

NCT05775497

Start date

May 1, 2024

Status verified date

Dec, 2024

Completion date

Dec 29, 2025

Anticipated

Primary completion date

Sep 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

  • 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)).

Study Design

Enrollment

88 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Weight Loss Program Only

Participants complete an online behavioral weight loss program.

experimental: Weight Loss Program + Coping with Stress Program

Participants complete (1) an online behavioral weight loss program and (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss.

experimental: Weight Loss Program + Coping with Stress Program + Body Image Program

Participants complete (1) an online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss, and (3) an adjunctive intervention for improving negative body image and reducing its impact on weight loss.

experimental: Weight Loss Program + Coping with Stress Program + Body Image Program + Social Support Program

Participants complete (1) an online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss, (3) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts, and (4) an adjunctive intervention for improving negative body image and reducing its impact on weight loss.

experimental: Weight Loss Program + Body Image Program + Social Support Program

Participants complete (1) an online behavioral weight loss program, (2) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts, and (3) an adjunctive intervention for improving negative body image and reducing its impact on weight loss.

experimental: Weight Loss Program + Coping with Stress Program + Social Support Program

Participants complete a (1) online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss, and (3) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts.

experimental: Weight Loss Program + Body Image Program

Participants complete (1) an online behavioral weight loss program and (2) an adjunctive intervention for improving negative body image and reducing its impact on weight loss.

experimental: Weight Loss Program + Social Support Program

Participants complete (1) an online behavioral weight loss program and (2) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts.

Interventions

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.

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.

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).

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 measure

  • Change in Weight [ Time Frame: 6 months ]
  • Proportion of Patients Achieving a Weight Loss of 5+% of Initial Weight [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Emily Panza, PhD

401-793-9714emily_panza@brown.edu

Locations

Weight Control and Diabetes Research Center

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Emily Panza, PhD

401-793-9714emily_panza@brown.edu

More Information

Sponsor

The Miriam Hospital

Last update posted

Dec 27, 2024

Last verified

Dec, 2024

Keywords

  • Sexual minority women
  • LGBTQ health
  • Weight loss

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-20. This information was provided to ClinicalTrials.gov by The Miriam Hospital on 2024-12-27.