Supplementing Evidence-based Commercial Weight Management Program With Inhibitory Control Training: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- BMI at Three Months
研究概览
简要总结
The purpose of this pilot study is to explore the benefits of supplementing the WW (formerly Weight Watchers) online program with a cognitive training game (PolyRules!) among adults with overweight or obesity.
详细描述
This two-arm pilot study will be used to estimate the effect size in weight loss of supplementing the WW (formerly Weight Watchers) online program with gamified inhibitory control training (PolyRules!) among adults with overweight or obesity. Participants ages 18 and older (n=30) will be randomly assigned to one of two study arms: (1) WW (formerly Weight Watchers) only or (2) WW + Gamified inhibitory control training (PolyRules!). All participants will complete demographic, medical history questionnaires and cognitive assessment battery at baseline/enrollment and after completing the 3-month intervention protocol. All interactions with PolyRules! and WW will be passively recorded to monitor the frequency of interaction with WW and PolyRules!.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Read, write and speak English with acceptable visual acuity
- •BMI between 25-40 kg/m^2
排除标准
- •Currently enrolled in weight loss interventions or undergoing bariatric surgery
- •Pregnant women
- •Individuals with severe cognitive delays or visual/hearing impairment
研究组 & 干预措施
WW + PolyRules!
Participants will receive 3-month access to the WW digital program and the PolyRules! app.
干预措施: WW + PolyRules! (Behavioral)
WW Only
Participants will receive 3-month access to the WW digital program.
干预措施: WW Only (Behavioral)
结局指标
主要结局
BMI at Three Months
时间窗: Baseline, 3 months
BMI will be calculated by aggregating participants' self-reported height in meters and weight in kilograms at baseline and at 3 months. Throughout the study, participants will be asked to self-report their weight through the WW (formerly Weight Watchers) online app. This data will be used to calculate change in BMI.
次要结局
- Correlation Between Dietary Logging Frequency and BMI Change.(From randomization to the end of treatment at 12 weeks)
- Correlation Between Completed Inhibitory Control Training Sessions and BMI Change.(From baseline to end of treatment at 12 weeks.)
- Mean Percentage of Days With Dietary Self-monitoring(From baseline to end of treatment at 12 weeks.)
- Completion Rate of Weight Self-monitoring(From baseline to end of treatment at 12 weeks)
- Completion Rate of Inhibitory Control Training Sessions(From baseline to end of treatment at 12 weeks)
- Participant Attrition Rate at Three Months(From enrollment to end of treatment at 12 weeks)
- Number of Participants Who Completed Timepoint Follow-ups(From Baseline to 12 Weeks)
研究者
Sarah Salvy
Professor, Department of Medicine
Cedars-Sinai Medical Center