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临床试验/NCT03400696
NCT03400696
已完成
不适用

Web-based Weight Loss Intervention

23andMe, Inc.1 个研究点 分布在 1 个国家目标入组 63,656 人2017年12月27日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Overweight and Obesity
发起方
23andMe, Inc.
入组人数
63656
试验地点
1
主要终点
Change in weight from week 1 to week 12 of intervention
状态
已完成
最后更新
5年前

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.

注册库
clinicaltrials.gov
开始日期
2017年12月27日
结束日期
2019年4月16日
最后更新
5年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
23andMe, Inc.
责任方
Sponsor

入排标准

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

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)

研究点 (1)

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