Web-based Weight Loss Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63,656
- 试验地点
- 2
- 主要终点
- Change in weight from week 1 to week 12 of intervention
研究概览
简要总结
Excess weight is a major risk factor underlying leading causes of death globally, including cardiovascular disease, type 2 diabetes, and some cancers. Among participants assigned to the same lifestyle intervention arms in prior weight loss randomized controlled trials, large inter-individual differences in weight loss success have been observed, ranging from >50lbs of weight loss to >10lbs of weight gain. Both genetic and non-genetic factors underlying differential adherence and weight loss success are poorly understood.
详细描述
23andMe aims to recruit 91,227 adults to participate in a web-based weight loss intervention. Primary aims include: a.) to confirm whether AG/GG individuals at MTIF3 rs1885988 lose more weight on lifestyle interventions; and b.) to test the performance of a randomized controlled trial vs. self-selection study design in terms of weight loss, drop-outs, and adherence. Secondary (exploratory) analyses will focus on discovery of genetic and non-genetic predictors of weight loss success overall, and examination of potential interactions by intervention type. Web-administered intervention content, videos, and forums will be surfaced to participants every two weeks, and self-reported surveys will be surfaced weekly for the active intervention duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •US-based men and women in self-reported 'good' or better health
- •Consented to participate in research
- •BMI 25-40 kg/m2
- •Not actively on a weight loss plan
- •Willing and able to modify eating and physical activity patterns
- •Not under a doctor's care for a serious medical condition
排除标准
- •Are pregnant, lactating, within 6 months postpartum, or planning to become pregnant in the next 6 months
- •Have diabetes (type 1 or 2) or are on hypoglycemic medications
- •Had a heart attack or stroke within the past year
- •Are unable or unwilling to follow a physical activity or diet intervention due to a medical condition or doctor's orders
- •Have an eating disorder
- •Have severe depression, anxiety, or other psychiatric conditions
研究组 & 干预措施
Randomized- Lower carbohydrate diet
干预措施: Lower carbohydrate diet (Behavioral)
Randomized- Higher fiber diet
干预措施: Higher fiber diet (Behavioral)
Randomized- Exercise focused
干预措施: Physical activity focused (Behavioral)
Participant chooses- Exercise focused
干预措施: Physical activity focused (Behavioral)
Participant chooses- Lower carbohydrate diet
干预措施: Lower carbohydrate diet (Behavioral)
Participant chooses- Higher fiber diet
干预措施: Higher fiber diet (Behavioral)
结局指标
主要结局
Change in weight from week 1 to week 12 of intervention
时间窗: 12 weeks
次要结局
- Change in waist circumference from week 1 to week 12 of intervention(12 weeks)
- Change in waist-to-hip ratio from week 1 to week 12 of intervention(12 weeks)