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)

• 批准号: 10293012
• 负责人: MARK Andrew ESPELAND
• 金额: $ 150万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 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/10293012
• 关键词: Adult; 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; Lead; 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 Clinical Trials; Randomized Controlled Clinical Trials; Resources; Risk; Risk Factors; Source; Specific qualifier value; Subgroup; Syndrome; Telephone Interviews; Time; Translating; United States; Weight; Weight maintenance regimen; adult obesity; age related; base; 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; resilience; response; sex; study population; therapy design

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2670万例 预计到2050年，比2005年增加近4.5倍，其中绝大多数人 超重或肥胖。2型糖尿病和超重/肥胖通常被描述为生物学上的加速器。 由于与寿命缩短、残疾风险增加和健康相关质量降低相关的衰老 生命然而，并不是所有患有这些疾病的人在以后的生活中都面临着同样的预后，有些人继续 保持相对较高的功能和独立性。这表明可以确定战略， 促进更健康的晚年生活体验。很自然地认为，行为干预，以促进和 保持体重减轻可以减轻衰老的后果。 我们建议进行展望扩展-2（LA-E2），以响应RFA-AG-21-028 Limited 继续展望未来研究的竞争，该研究强调“评估重要的健康- 随着时间的推移的相关结果”，在一个队列中，已被广泛表征超过18年， 强调“与健康老龄化和恢复力有关的结果;重大健康事件;医疗保健 利用率;以及预测、调解或以其他方式告知长期影响的相关行为和其他因素。 多领域生活方式干预对健康的影响，旨在产生和维持衰老中的体重减轻 2型糖尿病的治疗方法我们计划招募约2600名Look AHEAD参与者， 被随机分配到10年的强化生活方式干预， 维持体重减轻或糖尿病支持和教育的比较条件。这些人将是 通过电话采访和医疗保险联系，对这一问题进行了4年的跟踪调查，以评估这一问题的遗留问题。 对重要的晚年结局的干预。 RFA针对五个结局领域：1）多项功能，2）身体功能，3）认知功能，4） 卫生保健利用和费用，以及5）健康相关的生活质量和健康状况。这些目标和 成果构成我们的主要目标。我们还有重要的次要目标，正如RFA中所规定的那样，“研究 在这项特征鲜明的多样化研究中， 人口”。我们将描述晚年的结果是如何与临床措施，药物使用， 行为以及干预效果如何根据性别，种族/民族， 年龄肥胖和健康状况我们还将通过以下方式保持前瞻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信息，这是至关重要的，以改善老年人的照顾型 2糖尿病和超重或肥胖。