Study to Promote Weight Loss in Primary Care Practices
2018年2月6日 更新者：Ruth Weinstock、State University of New York - Upstate Medical University
Weight Loss in Primary Care: a Translation of the Diabetes Prevention Program
The purpose of this study is to determine if primary care based, telephone-delivered weight loss interventions are effective.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
257
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Obese
- 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
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Individual Telephone Intervention
Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.
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Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program).
In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants.
Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.
|
|
有源比较器：Group Telephone Intervention
Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.
|
Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program).
In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants.
Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Weight
大体时间：baseline, 1, 2, 3 years
|
Weight (kg)
|
baseline, 1, 2, 3 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Blood Pressure
大体时间：baseline, 1, 2, 3 years
|
Systolic blood pressure (mm Hg) / Diastolic blood pressure (mm Hg)
|
baseline, 1, 2, 3 years
|
|
Fasting Lipid Panel
大体时间：baseline, 1, 2, 3 years
|
LDL-cholesterol (mg/dL)
|
baseline, 1, 2, 3 years
|
|
Fasting Glucose Level
大体时间：baseline, 1, 2, 3 years
|
Fasting glucose (mg/dL)
|
baseline, 1, 2, 3 years
|
|
Health Behaviors (Diet, Physical Activity)
大体时间：baseline, 6 months, 1 and 2 years
|
National Cancer Institute Fat screener
|
baseline, 6 months, 1 and 2 years
|
|
SF-12 Physical Summary Score
大体时间：baseline, 6 months, 1 and 2 years
|
The impact of physical health on overall quality of life; higher score reflects better quality of life.
Range 0-100 (0 indicates the lowest level and 100 the highest level of health).
|
baseline, 6 months, 1 and 2 years
|
|
International Physical Activity Questionnaire
大体时间：baseline, 6 months, 1 and 2 years
|
Measure of physical activity is calculated as in mets/week
|
baseline, 6 months, 1 and 2 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ruth S. Weinstock, MD PhD、State University of New York - Upstate Medical University
- 首席研究员：Paula Trief, PhD、State University of New York - Upstate Medical University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Weinstock RS, Trief PM, Cibula D, Morin PC, Delahanty LM. Weight loss success in metabolic syndrome by telephone interventions: results from the SHINE Study. J Gen Intern Med. 2013 Dec;28(12):1620-8. doi: 10.1007/s11606-013-2529-7. Epub 2013 Jul 11.
- Trief PM, Cibula D, Delahanty LM, Weinstock RS. Depression, stress, and weight loss in individuals with metabolic syndrome in SHINE, a DPP translation study. Obesity (Silver Spring). 2014 Dec;22(12):2532-8. doi: 10.1002/oby.20916. Epub 2014 Sep 24.
- Trief PM, Weinstock RS, Cibula D, Delahanty LM. Sustained weight loss one year after group telephone intervention: 3-year results from the SHINE study. Diabetes Res Clin Pract. 2014 Dec;106(3):e74-8. doi: 10.1016/j.diabres.2014.09.032. Epub 2014 Oct 5.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年6月1日
初级完成 (实际的)
2012年10月1日
研究完成 (实际的)
2014年12月1日
研究注册日期
首次提交
2008年9月5日
首先提交符合 QC 标准的
2008年9月5日
首次发布 (估计)
2008年9月9日
研究记录更新
最后更新发布 (实际的)
2018年2月12日
上次提交的符合 QC 标准的更新
2018年2月6日
最后验证
2018年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Individual telephone intervention的临床试验
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动，不招人
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University of MinnesotaNational Institute of Mental Health (NIMH); Michigan Department of Community Health完全的