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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05775497
• Other study ID #: 1550062-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 13, 2023
• Est. completion date: March 29, 2024

Study information

• Verified date: February 2023
• Source: The Miriam Hospital
• Contact: Emily Panza, PhD
• Phone: 401-793-9714
• Email: Emily.Panza[@]Lifespan.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: March 29, 2024
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

• 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)).

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	National Institute on Minority Health and Health Disparities (NIMHD)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence to behavioral weight loss - Online metrics	There are a number of markers of adherence that tend to be highly correlated and predictive of weight loss success including engagement with the online intervention and number of self-monitoring entries. The investigators will use data collected by the Rx Weight Loss platform to determine the number of lessons viewed, number of self-monitoring data entries, and number of log-ins.	3 months after baseline
Other	Adherence to behavioral weight loss - Energy intake	There are a number of markers of adherence that tend to be highly correlated and predictive of weight loss success including daily tracking. Women will self-monitor their daily calorie intake using an app-based program (e.g., MyFitness Pal) and will report their weekly intake weekly in Rx Weight Loss for comparison to their weekly calorie goal.	3 months after baseline
Other	Adherence to behavioral weight loss - Physical activity	Weekly physical activity minutes will be assessed to determine adherence to the goal of 150 minutes of MVPA/week	3 and 6 months after baseline
Primary	Change in Weight	Body weight will be formally assessed by an RA at baseline, 3 months, and 6 months. Mean weight loss from baseline will be calculated.	6 months
Primary	Proportion of Patients Achieving a Weight Loss of 5+% of Initial Weight	Mean weight loss at 6 months will be used to determine the proportion of participants who achieved clinically significant (5+%) weight loss.	6 months
Secondary	Change in Weight	Body weight will be formally assessed by an RA at baseline, 3 months, and 6 months. Mean weight loss from baseline will be calculated.	3 months
Secondary	Proportion of Patients Achieving a Weight Loss of 5+% of Initial Weight	Mean weight loss at 3 months will be used to determine the proportion of participants who achieved clinically significant (5+%) weight loss.	3 months
Secondary	Change in skills for coping with stress	Skills for coping with stress will be measured with the 28-item Brief COPE Scale. This widely used scale assesses adaptive and maladaptive strategies for coping with stress using 14 subscales on a 1 (I havent been doing this at all) to 4 (Ive been doing this a lot) scale. Higher scores represent more frequent coping skill use.	3 and 6 months after baseline
Secondary	Change in perceived social support	Perceived social support will be measured with the 16-item Social Support Behaviors Scale (SSB), which assesses emotional, instrumental, and sexuality-specific social support on a 1-5 scale. Higher scores indicate more support. The SSB shows excellent internal consistency and validity in studies of SGM adults	3 and 6 months after baseline
Secondary	Change in negative body image	Negative body image will be measured with the widely used weight and shape concern subscales of the Eating Disorder Examination Questionnaire. 8 items assess shape concerns and 5 items assess weight concerns on a 0 (not at all) to 6 (markedly) scale.	3 and 6 months after baseline