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临床试验/NCT00749606
NCT00749606已完成不适用

Weight Loss in Primary Care: a Translation of the Diabetes Prevention Program

State University of New York - Upstate Medical University0 个研究点目标入组 257 人开始时间: 2009年6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
发起方
入组人数
257
主要终点
Weight

研究概览

简要总结

The purpose of this study is to determine if primary care based, telephone-delivered weight loss interventions are effective.

详细描述

Obesity is related to the rising incidence of type 2 diabetes. Cost-effective interventions leading to sustained weight loss are needed to improve the public health and reverse the alarming rise in diabetes, its cardiovascular complications and other obesity-related illnesses. The Diabetes Prevention Program is identified as a model for a successful weight loss intervention. The proposed study is a randomized controlled trial of 2 active telephone-based interventions based on the Diabetes Prevention Model that will be delivered at primary care sites.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Metabolic syndrome
  • Read and write English
  • Planning to stay in treatment with their PCP for the next 3 years
  • On stable doses of medications for chronic diseases such as hypothyroidism for 3 years

排除标准

  • Unstable health
  • Diabetes mellitus
  • Severe medical comorbidities that might interfere with their ability to participate in intervention such as severe psychiatric disease or significant heart disease.

研究组 & 干预措施

Individual Telephone Intervention

Experimental

Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.

干预措施: Individual telephone intervention (Behavioral)

Group Telephone Intervention

Active Comparator

Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.

干预措施: Group telephone intervention (Behavioral)

结局指标

主要结局

Weight

时间窗: baseline, 1, 2, 3 years

Weight (kg)

次要结局

  • Fasting Lipid Panel(baseline, 1, 2, 3 years)
  • Blood Pressure(baseline, 1, 2, 3 years)
  • SF-12 Physical Summary Score(baseline, 6 months, 1 and 2 years)
  • Fasting Glucose Level(baseline, 1, 2, 3 years)
  • Health Behaviors (Diet, Physical Activity)(baseline, 6 months, 1 and 2 years)
  • International Physical Activity Questionnaire(baseline, 6 months, 1 and 2 years)

研究者

发起方
State University of New York - Upstate Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ruth Weinstock

Principal Investigator

State University of New York - Upstate Medical University

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