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临床试验/NCT01642199
NCT01642199已完成不适用

A Randomized Trial Testing Lay Health Coaches for Obesity Treatment

University of Connecticut1 个研究点 分布在 1 个国家目标入组 278 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
278
试验地点
1
主要终点
Weight change from the initial assessment to the 12-month assessment measured on a digital scale to the nearest 0.1-kilogram

研究概览

简要总结

The primary aim of this study is to determine whether reduced intensity behavioral weight loss treatment (rBWL) + Peer Health Coaches yields significantly greater weight loss than rBWL + Mentor Health Coaches and rBWL alone.

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
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Body Mass Index between 30 and 40
  • •Age between 40 and 60 years
  • •English speaking

排除标准

  • •Are unwilling to communicate regularly with a weight loss coach
  • •Report not being able to walk 2 blocks (1/4 mile) without stopping
  • •Are currently participating in a weight loss program, taking a weight loss medication, have a history of bariatric surgery, or lost ≥ 5% of body weight during the past 6-months
  • •Are pregnant, lactating, less than 6-months post-partum, or plan to become pregnant during the intervention timeframe
  • •Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire
  • •Report a medical condition that would jeopardize their safety if involved in a weight management program with diet and exercise guidelines
  • •Report conditions that, in the judgment of the PI, would render the participant unlikely to follow the study protocol (e.g., relocation, dementia, terminal illness, substance abuse).

研究组 & 干预措施

Reduced Intensity Behavioral Weight Loss + Peer Health Coach

Active Comparator

干预措施: Reduced Intensity Behavioral Weight Loss + Peer Health Coach (Behavioral)

Reduced Intensity Behavioral Weight Loss + Mentor Health Coach

Active Comparator

干预措施: Reduced Intensity Behavioral Weight Loss + Mentor Health Coach (Behavioral)

Reduced Intensity Behavioral Weight Loss

Active Comparator

干预措施: Reduced Intensity Behavioral Weight Loss (Behavioral)

结局指标

主要结局

Weight change from the initial assessment to the 12-month assessment measured on a digital scale to the nearest 0.1-kilogram

时间窗: baseline to 12 months

次要结局

  • Direction of social comparison between participants and their Peer or Mentor weight loss coach(2-weeks, 3-months, 6-months, 9-months, and 12-months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tricia Leahey

Associate Professor

University of Connecticut

研究点 (1)

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