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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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 provi
• Поведенческое 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
• Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (5)

• Change in Weight [Срок оценки: 3 months]
• Proportion of Patients Achieving a Weight Loss of 5+% of Initial Weight [Срок оценки: 3 months]
• Change in skills for coping with stress [Срок оценки: 3 and 6 months after baseline]
• Change in perceived social support [Срок оценки: 3 and 6 months after baseline]
• Change in negative body image [Срок оценки: 3 and 6 months after baseline]

Критерии участия

• 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)).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Weight Control and Diabetes Research Center — Providence

Идентификаторы

NCT: NCT05775497 · 1550062-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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