Action for Health in Diabetes (Look AHEAD) Extended Follow-up (LA-E2)

糖尿病健康行动（前瞻性）延长随访 (LA-E2)

基本信息

批准号：
10698054
负责人：
MARK Andrew ESPELAND
金额：
$ 140.87万
依托单位：
WAKE FOREST UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-08-01 至 2026-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10698054
关键词：
Adult Age Aging Ancillary Study Behavior Behavior Therapy Behavioral Behavioral trial Biological Aging Blood Pressure Body Weight decreased Caloric Restriction Cardiovascular Diseases Caring Chronic Disease Chronic Kidney Failure Clinical Control Groups Counseling Data Development Diabetes Mellitus Diet Education Elderly Enrollment Ethnic Origin Event Face Gender Glycosylated hemoglobin A Goals Health Health Status Healthcare Heterogeneity Individual Insulin Interest Group Intervention Investigation Life Life Experience Long-Term Effects Longevity Measures Mediating Medicare Mental Depression Metabolic Metformin Monitor Non-Insulin-Dependent Diabetes Mellitus Obesity Outcome Overweight Participant Pharmaceutical Preparations Phenotype Physical Function Physical activity Positioning Attribute Predictive Factor Prognosis Protocols documentation Race Randomized Randomized Controlled Clinical Trials Resources Risk Factors Risk Reduction Source Specific qualifier value Subgroup Syndrome Telephone Interviews Time Translating United States Weight Weight maintenance regimen adult obesity age related cognitive function cohort comparison intervention cost depressive symptoms design disability disability risk follow-up frailty health care service utilization health related quality of life healthy aging high risk improved indexing intervention effect lifestyle intervention middle age multiple chronic conditions randomized, clinical trials resilience response sex study population therapy design

项目摘要

Type 2 diabetes mellitus is common among older individuals in the United States, with 26.7 million cases projected by 2050, an almost 4.5-fold increase from 2005, and the vast majority of these individuals have overweight or obesity. Type 2 diabetes and overweight/obesity are often described as accelerators of biological aging due to associations with decreased lifespan, increased disability risk, and reduced health-related quality of life. Yet, not all individuals with these conditions face the same prognosis in later life, and some continue to maintain relatively high levels of function and independence. This suggests that strategies could be identified to promote healthier later-life experiences. It is natural to consider that behavioral intervention to promote and maintain weight loss may mitigate against the consequences of aging. We propose to conduct the Look AHEAD Extension-2 (LA-E2) in response to RFA-AG-21-028 Limited Competition for the Continuation of the Look AHEAD Study, which emphasizes “assessing important health- related outcomes over time” in a cohort that has been extensively characterized over 18 years, with an emphasis on “outcomes that are relevant to healthy aging and resilience; major health events; healthcare utilization; and relevant behavioral and other factors that predict, mediate, or otherwise inform the long-term health effects of a multi-domain lifestyle intervention designed to produce and maintain weight loss in aging adults with type 2 diabetes mellitus.” We plan to enroll approximately 2600 Look AHEAD participants who had been randomly assigned to 10 years of either Intensive Lifestyle Intervention that successfully induced and maintained weight loss or a comparator condition of Diabetes Support and Education. These individuals will be followed for 4 additional years, using telephone interviews and Medicare linkage, to assess the legacy of this intervention on important later-life outcomes. The RFA targets five domains of outcomes: 1) Multimorbidity, 2) Physical function, 3) Cognitive function, 4) Health care utilization and costs, and 5) Health related quality of life and health status. These goals and outcomes frame our primary aims. We also have important secondary aims, as specified in the RFA, “to study the heterogeneity of diabetes and chronic disease development in this well-characterized, diverse study population.” We will describe how later-life outcomes are associated with clinical measures, medication use, and behaviors and how intervention effects vary among individuals depending on their gender, race/ethnicity, age, obesity, and health status. We will also maintain the Look AHEAD cohort as a source of discovery by promoting ancillary studies, dissemination, and the distribution of well-documented public use data, and through scientific interest groups. Our overarching goal is to provide information that is vital for improving the care of older individuals with type 2 diabetes mellitus and overweight or obesity.

2 型糖尿病在美国老年人中很常见，有 2670 万病例预计到 2050 年，将比 2005 年增加近 4.5 倍，而且其中绝大多数人超重或肥胖通常被描述为生物学的加速器。由于寿命缩短、残疾风险增加和健康相关质量下降而导致的老龄化然而，并非所有患有这些疾病的人在以后的生活中都会面临相同的预后，有些人仍然会面临同样的预后。保持相对较高水平的职能和独立性这表明可以确定战略。促进更健康的晚年生活体验是很自然的考虑行为干预来促进和保持体重减轻可以减轻衰老的后果。我们建议进行 Look AHEAD Extension-2 (LA-E2) 以响应 RFA-AG-21-028 Limited 继续“展望未来”研究的竞赛，该研究强调“评估重要的健康- 随着时间的推移相关的结果”在一个经过 18 年专门描述的队列中，强调“与健康老龄化和复原力相关的成果；利用率；以及预测、调节或以其他方式告知长期的相关行为和其他因素。旨在产生和维持衰老过程中体重减轻的多领域生活方式干预的健康影响患有 2 型糖尿病的成年人。”我们计划招募大约 2600 名患有 2 型糖尿病的 Look AHEAD 参与者。被随机分配到 10 年的强化生活方式干预中，成功诱导和这些人将保持体重减轻或糖尿病支持和教育的对照条件。又进行了 4 年的跟踪调查，通过电话访谈和 Medicare 联系来评估这一遗留问题对重要的晚年生活结果进行干预。 RFA 针对五个领域的结果：1) 多种疾病，2) 身体功能，3) 认知功能，4) 医疗保健利用和成本，以及 5) 与健康相关的生活质量和健康状况。结果构成了我们的主要目标，正如 RFA 中所规定的，我们还有重要的次要目标，“研究”。这项特征鲜明、多样化的研究中糖尿病和慢性病发展的异质性我们将描述晚年生活结果如何与临床措施、药物使用、和行为以及干预效果如何根据个人的性别、种族/民族而变化，我们还将维护 Look AHEAD 队列作为发现的来源。促进辅助研究、传播和分发有据可查的公共使用数据，以及通过科学兴趣小组。我们的首要目标是提供对于改善老年痴呆症患者的护理至关重要的信息 2 糖尿病和超重或肥胖。