CLINICAL TRIAL: LOOK AHEAD: ACTION FOR HEALTH IN DIABETES
临床试验:展望未来:糖尿病健康行动
基本信息
- 批准号:8166755
- 负责人:
- 金额:$ 1.18万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2009
- 资助国家:美国
- 起止时间:2009-12-01 至 2010-11-30
- 项目状态:已结题
- 来源:
- 关键词:AdultAffectBody Weight decreasedBody mass indexBone DensityCardiovascular DiseasesCardiovascular systemCaringClinical TrialsComputer Retrieval of Information on Scientific Projects DatabaseDiabetes MellitusDiseaseEducationEventFrequenciesFundingGrantHealthHealth PersonnelIncidenceIndividualInstitutionInterventionIntervention StudiesLife StyleMedicalNon-Insulin-Dependent Diabetes MellitusOutcomeOutcome MeasureOverweightParticipantPatient Self-ReportPersonsPharmaceutical PreparationsPhysical activityProcessRandomizedRandomized Controlled Clinical TrialsRecording of previous eventsRecruitment ActivityResearchResearch PersonnelResourcesSocial supportSourceUnited StatesUnited States National Institutes of Healtharmcardiovascular risk factorcohortcost effectivenessdesigndiabetes managementfitnessfollow-upimprovedintervention programlifestyle interventionmeetingsmortalitynutritionprogramsweight loss intervention
项目摘要
This subproject is one of many research subprojects utilizing the
resources provided by a Center grant funded by NIH/NCRR. The subproject and
investigator (PI) may have received primary funding from another NIH source,
and thus could be represented in other CRISP entries. The institution listed is
for the Center, which is not necessarily the institution for the investigator.
The Look AHEAD, multicenter, randomized controlled clinical trial will examine the impact on several health outcomes of a lifestyle intervention program designed to produce weight loss. The primary study objective is to determine whether participation in a lifestyle intervention is effective in reducing the incidence of serious cardiovascular disease events in overweight adults with type 2 diabetes. Other important study objectives are to assess the impact of weight loss and fitness changes on a range of disease processes and outcomes and to evaluate the cost-effectiveness of the weight loss intervention.
The study cohort will include 5,000 overweight (body mass index of at least 25 kg/m2) individuals with type 2 diabetes (as established by self-report with verification or treatment). Sixteen centers across the United States will each recruit approximately 313 persons into the trial. Individuals with or without a prior history of cardiovascular disease will be recruited.
Participants will be stratified according to center, and randomly assigned to either Lifestyle Intervention or a control intervention, Diabetes Support and Education. The Lifestyle Intervention is designed to produce and maintain weight loss and increased fitness through a lifestyle program augmented, if indicated, by subsequent use of weight loss medication. This intervention includes individual and group sessions with weekly meetings for six months followed by decreasing frequency of contact over the remainder of the trial. The Diabetes Support and Education group will receive sessions of nutrition and physical activity education and social support. Participants in both arms will receive comparable education in issues related to diabetes management. Participants in Look AHEAD will receive their general medical care from a health care provider who is separate from the Look AHEAD staff.
Participants will be followed annually until 2012, resulting in a maximum of 11.5 years of participant follow-up. Outcome measures include those that might be positively affected by weight loss (e.g. cardiovascular events) and those that might be negatively affected (e.g. bone mineral density). The study will also assess some of the potential mechanisms by which weight loss may influence cardiovascular events and mortality (e.g. through improved control of cardiovascular risk factors).
这个子项目是许多研究子项目中利用
资源由NIH/NCRR资助的中心拨款提供。子项目和
调查员(PI)可能从NIH的另一个来源获得了主要资金,
并因此可以在其他清晰的条目中表示。列出的机构是
该中心不一定是调查人员的机构。
这项前瞻性、多中心、随机对照的临床试验将检查旨在实现减肥的生活方式干预计划对几种健康结果的影响。主要的研究目标是确定参与生活方式干预是否有效地降低了患有2型糖尿病的超重成年人的严重心血管疾病事件的发生率。其他重要的研究目标是评估减肥和健康变化对一系列疾病过程和结果的影响,并评估减肥干预的成本效益。
研究队列将包括5000名超重(体重指数至少为25公斤/平方米)的2型糖尿病患者(通过自我报告和验证或治疗确定)。美国的16个中心将每个中心招募大约313人参加试验。有或没有心血管疾病病史的个人将被招募。
参与者将根据中心进行分层,并随机分配到生活方式干预或对照干预、糖尿病支持和教育。生活方式干预旨在通过生活方式计划来产生和维持减肥和增加健康,如果需要的话,可以通过随后使用减肥药物来加强。这种干预包括个人和小组会议,每周举行一次会议,持续六个月,然后在剩余的试验中减少接触频率。糖尿病支持和教育小组将接受营养和体育活动、教育和社会支持的会议。两个机构的参与者都将接受与糖尿病管理相关问题的类似教育。前瞻计划的参与者将从独立于前瞻工作人员的医疗保健提供者那里获得一般医疗护理。
参与者将每年接受跟踪,直至2012年,因此参与者的跟踪时间最长为11.5年。结果衡量标准包括那些可能受到体重减轻积极影响的指标(例如心血管事件)和那些可能受到负面影响的指标(例如骨密度)。该研究还将评估减肥可能影响心血管事件和死亡率的一些潜在机制(例如,通过改善对心血管危险因素的控制)。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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John P. Foreyt其他文献
Does personality or psychopathology predict disability in chronic pain patients?
性格或精神病理学是否可以预测慢性疼痛患者的残疾?
- DOI:
10.1080/096382800296746 - 发表时间:
2000 - 期刊:
- 影响因子:2.2
- 作者:
J. Linder;Walker S. Carlos Poston II;Keith C. Haddock;John P. Foreyt;M. Ericsson - 通讯作者:
M. Ericsson
Aversive conditioning treatment of overweight
- DOI:
10.1016/s0005-7894(78)80018-5 - 发表时间:
1978-11-01 - 期刊:
- 影响因子:
- 作者:
Richard A. Frohwirth;John P. Foreyt - 通讯作者:
John P. Foreyt
Incremental Benefit of Adherence in a Community-based Weight Loss Program
- DOI:
10.1016/j.jacl.2013.03.027 - 发表时间:
2013-05-01 - 期刊:
- 影响因子:
- 作者:
Craig A. Johnston;Stephanie Rost;Karen Miller-Kovach;Jennette P. Moreno;John P. Foreyt - 通讯作者:
John P. Foreyt
Tu1325: BEHAVIORAL WEIGHT LOSS INTERVENTIONS FOR PATIENTS WITH NAFLD: A SYSTEMATIC SCOPING REVIEW TO INCREASE THEIR UNDERSTANDING AND USE IN RESEARCH AND PRACTICE.
- DOI:
10.1016/s0016-5085(22)63746-6 - 发表时间:
2022-05-01 - 期刊:
- 影响因子:
- 作者:
Kyle S. Liu;Sydney Schmitt;Fasiha Kanwal;John P. Foreyt;Maya Balakrishnan - 通讯作者:
Maya Balakrishnan
John P. Foreyt的其他文献
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{{ truncateString('John P. Foreyt', 18)}}的其他基金
CLINICAL TRIAL: LOOK AHEAD: ACTION FOR HEALTH IN DIABETES
临床试验:展望未来:糖尿病健康行动
- 批准号:
8356762 - 财政年份:2010
- 资助金额:
$ 1.18万 - 项目类别:
CLINICAL TRIAL: LOOK AHEAD: ACTION FOR HEALTH IN DIABETES
临床试验:展望未来:糖尿病健康行动
- 批准号:
7950677 - 财政年份:2008
- 资助金额:
$ 1.18万 - 项目类别:
Effectiveness of Brief Counseling for Weight Management
体重管理简短咨询的有效性
- 批准号:
6332112 - 财政年份:2001
- 资助金额:
$ 1.18万 - 项目类别:
Effectiveness of Brief Counseling for Weight Management
体重管理简短咨询的有效性
- 批准号:
6517817 - 财政年份:2001
- 资助金额:
$ 1.18万 - 项目类别:
Effectiveness of Brief Counseling for Weight Management
体重管理简短咨询的有效性
- 批准号:
6635312 - 财政年份:2001
- 资助金额:
$ 1.18万 - 项目类别:
Clinical Center for Look AHEAD: Health in Diabetes
Look AHEAD 临床中心:糖尿病健康
- 批准号:
6178224 - 财政年份:1999
- 资助金额:
$ 1.18万 - 项目类别:
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