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临床试验/NCT03396653
NCT03396653已完成不适用

Peer Support for Weight Loss Maintenance

University of Connecticut2 个研究点 分布在 1 个国家目标入组 849 人开始时间: 2018年2月19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
849
试验地点
2
主要终点
Weight Change (kg)

研究概览

简要总结

The primary aim of this study is to test the efficacy of patient-provided treatment for weight-loss maintenance.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age between 18-75
  • •Body Mass Index between 25-50
  • •English Speaking

排除标准

  • •Report being unable to walk 2 blocks without stopping
  • •Are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months
  • •Are pregnant or plan to become pregnant within 1 year
  • •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 could jeopardize their safety in a weight control program with diet and exercise guidelines
  • •Report conditions that, in the judgment of the PI, would render them unlikely to follow the protocol (e.g., relocation, dementia, unable to read and write in English)
  • •Have no Internet access.

研究组 & 干预措施

Peer-Delivered Weight Maintenance

Active Comparator

Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group).

干预措施: Peer-delivered Weight Maintenance (Behavioral)

Professionally-Delivered Weight Maintenance

Active Comparator

Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions.

干预措施: Professionally-Delivered Weight Maintenance (Behavioral)

结局指标

主要结局

Weight Change (kg)

时间窗: Baseline to 18-months

Weight change (measured on a digital scale to the nearest 0.1-kilogram) from Phase II Baseline (post-Phase I) to the end of the Phase II maintenance program (18 months).

次要结局

  • Blood Pressure (mmHg)(Baseline to 18-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 (2)

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