Optimizing an Online Behavioral Weight Loss Intervention and Novel Culturally Tailored Components for Sexual Minority Women: MOST Optimization Phase
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Change in Weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)).
排除标准
- 未提供
研究组 & 干预措施
Weight Loss Program Only
Participants complete an online behavioral weight loss program.
干预措施: Behavioral weight loss intervention (Online; Rx Weight Loss) (Behavioral)
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.
干预措施: Behavioral weight loss intervention (Online; Rx Weight Loss) (Behavioral)
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.
干预措施: Minority stress intervention (Behavioral)
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.
干预措施: Behavioral weight loss intervention (Online; Rx Weight Loss) (Behavioral)
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.
干预措施: Minority stress intervention (Behavioral)
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.
干预措施: Negative body image intervention (Behavioral)
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.
干预措施: Behavioral weight loss intervention (Online; Rx Weight Loss) (Behavioral)
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.
干预措施: Minority stress intervention (Behavioral)
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.
干预措施: Social support intervention (Behavioral)
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.
干预措施: Negative body image intervention (Behavioral)
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.
干预措施: Behavioral weight loss intervention (Online; Rx Weight Loss) (Behavioral)
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.
干预措施: Social support intervention (Behavioral)
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.
干预措施: Negative body image intervention (Behavioral)
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.
干预措施: Behavioral weight loss intervention (Online; Rx Weight Loss) (Behavioral)
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.
干预措施: Minority stress intervention (Behavioral)
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.
干预措施: Social support intervention (Behavioral)
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.
干预措施: Behavioral weight loss intervention (Online; Rx Weight Loss) (Behavioral)
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.
干预措施: Negative body image intervention (Behavioral)
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.
干预措施: Behavioral weight loss intervention (Online; Rx Weight Loss) (Behavioral)
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.
干预措施: Social support intervention (Behavioral)
结局指标
主要结局
Change in Weight
时间窗: 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
时间窗: 6 months
Mean weight loss at 6 months will be used to determine the proportion of participants who achieved clinically significant (5+%) weight loss.
次要结局
- Change in negative body image(3 and 6 months after baseline)
- Change in Weight(3 months)
- Proportion of Patients Achieving a Weight Loss of 5+% of Initial Weight(3 months)
- Change in skills for coping with stress(3 and 6 months after baseline)
- Change in perceived social support(3 and 6 months after baseline)