Action for Health in Diabetes Continuation (Look AHEAD)

糖尿病继续健康行动（展望未来）

• 批准号: 8599565
• 负责人: Rena R Wing
• 金额: $ 85.17万
• 依托单位: MIRIAM HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8599565
• 关键词: Address; Adherence; Adverse effects; Aging; Amputation; Ancillary Study; Beck depression inventory; Body Weight decreased; Cardiovascular Diseases; Clinic Visits; Clinical; Clinical Trials; Cohort Studies; DSM-IV; Data; Dementia; Dependency; Desire for food; Diabetes Mellitus; Diabetic Angiopathies; Diagnosis; Disease Marker; Education; Electrocardiogram; End stage renal failure; Epidemic; Event; Fracture; Funding; Genotype; Health; Hormones; Human; Hypoglycemia; Impaired cognition; Impairment; Individual; Intervention; Kidney Diseases; Laser Surgery; Maintenance; Major Depressive Disorder; Malignant Neoplasms; Measures; Medical Care Costs; Mental Depression; Meta-Analysis; Neuropathy; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Observational Study; Outcome; Outcome Assessment; Overweight; Participant; Patient Self-Report; Patients; Peripheral Nervous System Diseases; Pharmaceutical Preparations; Physical Function; Physical activity; Physiological; Population; Prevalence; Probability; Protocols documentation; Publications; Quality of life; Questionnaires; Randomized; Randomized Clinical Trials; Recording of previous events; Renal function; Research Infrastructure; Resources; Retinal; Risk; Safety; Subgroup; Telephone; Testing; Time; Translating; Vertebral column; Weight Gain; aged; arm; autonomic neuropathy; base; cardiovascular disorder risk; cardiovascular risk factor; clinical research site; cognitive function; cohort; cost; cost effective; depressive symptoms; design; diabetes control; diabetes prevention program; disability; follow-up; functional disability; genetic analysis; geriatric depression; glycemic control; healthy aging; lifestyle intervention; middle age; mild cognitive impairment; minor depressive disorder; mortality; population health; post gamma-globulins; psychologic; public health priorities; public health relevance; success; therapy design

DESCRIPTION (provided by applicant): The aging of the population and the epidemic of obesity have led to a rapid increase in the number of older, obese individuals with diabetes. Little is known about the long-term health effects of lifestyle intervention designed to lower weight and increase physical activity in this population. This application, which responds to RFA-DK-12-502, is submitted by one of the 16 clinical centers in the Action for Health in Diabetes (Look AHEAD) Consortium. All 16 clinical sites and the Coordinating Center have submitted parallel applications. This application proposes to continue the Look AHEAD clinical trial as an observational cohort study and to follow participants with new assessments of the health problems of greatest concern in older, obese individuals with type 2 diabetes. We will test whether random assignment to 9-11 years of intensive lifestyle intervention, compared to a control condition of diabetes support and education, results in improvements in 1) physical function, impairment and disability, 2) cognitive function and impairment, 3) diabetes control and microvascular complications, 4) late life depression, and 5) fractures and cancers. Secondary aims are to examine whether subgroup differences observed during the trial (which raised concern about possible unfavorable effects of intensive lifestyle intervention in those with a prio history of cardiovascular disease) endure and whether the excellent weight losses achieved in the intensive lifestyle intervention arm are maintained despite the absence of continued intervention activities. The Continuation will also support ongoing ancillary studies, maintain infrastructure for new ancillary studies, and sustain thorough analyses and publication of the data collected by Look AHEAD. We will continue to follow the Look AHEAD cohort (approximately 4,000 participants) across the 16 clinical sites. Participants entered the trial 9-1 years ago when they were obese or overweight and aged 45-76, and were randomly assigned with equal probability to either an intensive lifestyle intervention that has induced sustained weight loss and increased physical activity or control condition (diabetes support and education). Both arms have had excellent retention. Interventions were discontinued in Sept, 2012, but follow-up of the cohort continues. This application will fund one additional clinic visit and ongoing telephone-based outcome assessment. This application builds on the remarkable success of the Look AHEAD in inducing and sustaining weight loss and retaining participants. The planned continuation addresses important public health priorities for a rapidly growing and under-studied segment of the US population in a cost-effective manner, leveraging the extensive resources available from Look AHEAD.

描述（由申请人提供）：人口老龄化和肥胖的流行导致年龄较大的肥胖患者数量迅速增加。对于旨在降低体重和增加该人群体育锻炼的生活方式干预的长期健康影响知之甚少。该应用程序对RFA-DK-12-502做出了响应，是由16个临床中心之一提交的糖尿病疗法（前面）财团的临床中心之一。所有16个临床站点和协调中心都提交了并行应用。 该申请建议继续作为一项观察队列研究的临床试验，并跟踪参与者对年龄较大的2型糖尿病患者的健康问题的新评估。我们将测试与糖尿病支持和教育的控制状况相比，将其随机分配到9 - 11年的强化生活方式干预措施中是否会改善1）身体功能，障碍和残疾，2）2）认知功能和障碍，3）糖尿病控制和微血管控制，4）晚期生命抑郁症以及5）晚期菌株和5）分裂和Cancers and Cancers and Cancers和Cancers。次要目的是检查试验期间观察到的亚组差异（这引起了人们对患有心血管疾病史的人的强化生活方式干预可能不利影响的关注），尽管没有继续干预活动，但仍保持着强化生活方式干预臂中的良好体重损失。延续还将支持正在进行的辅助研究，维护新辅助研究的基础设施，并维持对未来的数据收集的数据的彻底分析和发布。 我们将继续遵循16个临床部位的未来外观（约4,000名参与者）。参与者在9-1年前参加了试验，当时他们肥胖或超重并以45-76岁年龄段，并随机分配了同等可能性，以便强烈的生活方式干预措施导致持续的体重减轻，体育锻炼或对照状况增加（糖尿病支持和教育）。两臂都有出色的保留率。干预措施于2012年9月停止，但对队列的随访仍在继续。该申请将为额外的诊所提供资金 以及正在进行的基于电话的结果评估。 该应用程序基于诱发和维持体重减轻和留住参与者的显着成功的杰出成功。计划的延续旨在以具有成本效益的方式迅速增长和研究不足的美国人口的重要公共卫生优先事项，从而利用了未来的大量资源。