跳至主要内容
临床试验/NCT04645108
NCT04645108已完成不适用

Randomized, Parallel Trial of Overweight Men and Women Using a Coached or Non-Coached Weight Loss Intervention

Noom Inc.1 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2020年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Noom Inc.
入组人数
246
试验地点
1
主要终点
Self reported in app engagement measures

研究概览

简要总结

To evaluate the effect of one-on-one coaching in the Noom Healthy Weight Program, a digital behavior change, weight loss intervention, compared to the same program with no coaching, as well as influential factors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able to understand and provide informed consent
  • 18-65 years old
  • Self-report of good health (physical and mental)
  • Not diagnosed with diabetes
  • Overweight or obesity (BMI ≥ 27)
  • Able to meet our criteria of adherence to the program (at least 1 engagement per week on one of the following: logged exercise, logged meals, steps, weigh-ins, coach messages, read articles, and days with at least one weigh-in.) For females
  • Not 6 months postpartum
  • Not planning to become pregnant in the next 5 months.

排除标准

  • Inability or unwillingness of a participant to give written informed consent
  • Currently pregnant or ≤ 6 months postpartum
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the quality of the data E.g., evidence of an eating disorder, major chronic condition

结局指标

主要结局

Self reported in app engagement measures

时间窗: 4 months

self reported and automatically logged

Weight

时间窗: 4 months

Self reported

次要结局

  • Eating Behavior via the Dutch Eating Behavior Questionnaire(4 months)
  • Resilience via Devereux Adult Resilience Survey(4 months)
  • Quality of Life Via SF-12(4 months)
  • Self Efficacy via General Self-Efficacy Scale(4 months)
  • Linguistic Features via Linguistic Inquiry Word Count (LIWC)(16 weeks)

研究者

发起方
Noom Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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