U01AG073697

Action for Health in Diabetes (Look AHEAD) Extended Follow-Up (LA-E2) - 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. 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. This study emphasizes "assessing important health-related outcomes over time" in a cohort that has been extensively characterized over 18 years. The emphasis is 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) healthcare 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.

Wake Forest University Health Sciences

TO ENCOURAGE BIOMEDICAL, SOCIAL, AND BEHAVIORAL RESEARCH AND RESEARCH TRAINING DIRECTED TOWARD GREATER UNDERSTANDING OF THE AGING PROCESS AND THE DISEASES, SPECIAL PROBLEMS, AND NEEDS OF PEOPLE AS THEY AGE. THE NATIONAL INSTITUTE ON AGING HAS ESTABLISHED PROGRAMS TO PURSUE THESE GOALS. THE DIVISION OF AGING BIOLOGY EMPHASIZES UNDERSTANDING THE BASIC BIOLOGICAL PROCESSES OF AGING. THE DIVISION OF GERIATRICS AND CLINICAL GERONTOLOGY SUPPORTS RESEARCH TO IMPROVE THE ABILITIES OF HEALTH CARE PRACTITIONERS TO RESPOND TO THE DISEASES AND OTHER CLINICAL PROBLEMS OF OLDER PEOPLE. THE DIVISION OF BEHAVIORAL AND SOCIAL RESEARCH SUPPORTS RESEARCH THAT WILL LEAD TO GREATER UNDERSTANDING OF THE SOCIAL, CULTURAL, ECONOMIC AND PSYCHOLOGICAL FACTORS THAT AFFECT BOTH THE PROCESS OF GROWING OLD AND THE PLACE OF OLDER PEOPLE IN SOCIETY. THE DIVISION OF NEUROSCIENCE FOSTERS RESEARCH CONCERNED WITH THE AGE-RELATED CHANGES IN THE NERVOUS SYSTEM AS WELL AS THE RELATED SENSORY, PERCEPTUAL, AND COGNITIVE PROCESSES ASSOCIATED WITH AGING AND HAS A SPECIAL EMPHASIS ON ALZHEIMER'S DISEASE. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.866 - Aging Research

National Institute on Aging (NIA) [HHS - NIH]

Winston Salem, North Carolina 27157 United States

Single Zip Code

Limited Competition for the Continuation of the Look AHEAD (Action for Health in Diabetes) Study (U01 Clinical Trial Not Allowed) (RFA-AG-21-028)

Amendment Since initial award the total obligations have increased 371% from $1,500,000 to $7,064,037.