Over 25% of the US population >65 years of age have type 2 diabetes and 80% of these individuals are overweight or obese. These individuals face shortened lifespans, increased health care needs, greater medical complications, and lower quality of life relative to those of similar age without these conditions. Lifestyle interventions focused on weight loss are recommended for overweight and obese individuals with type 2 diabetes, but whether these interventions meaningfully improve the lives of older individuals with diabetes over extended follow-up is unknown. Look AHEAD is a randomized trial comparing the effects of intensive lifestyle intervention (ILI) focused on weight loss achieved through healthy eating and increased physical activity versus a control group given Diabetes Support and Education (DSE) in overweight and obese individuals with type 2 diabetes. Although ILI did not produce beneficial effects on the primary and secondary outcomes related to cardiovascular disease, it did produce beneficial effects on a broad spectrum of health parameters during the period of the intervention. The LA Extension (LA-E) will examine whether ILI, provided for 10 years during mid- life, has enduring benefits that persist beyond the period of the intervention for older individuals with diabetes. We propose to follow approximately 3,800 participants (current ages 58-89 years) for 4.5 additional years with biennial clinic visits and 6-month outcomes phone calls. The primary aims of LA-E are to test whether ILI relative to DSE has long term legacy effects on 1) increased lifespan and 2) reduced health care costs. Secondary aims test whether ILI relative to DSE has long-term effects on key dimensions of healthy aging: less frailty, reduced diabetic microvascular complications, and improved quality of life. LA-E will also compare long- term trajectories of weight, physical activity, fat and lean mass, and bone density and examine how these are related to outcomes. LA-E focuses on the clinical outcomes that are most relevant to healthy aging and resilience and will provide the long-term data needed to frame guidelines related to lifestyle intervention in the care of older overweight or obese individuals with type 2 diabetes.

Public Health Relevance

Weight loss is recommended for overweight and obese individuals with type 2 diabetes, but the long-term effects of such approaches on the issues of greatest concern to older individuals --including mortality, health care utilization and costs, diabetic complications, quality of life, and frailty -- remain untested. The Look AHEAD-Extension will follow approximately 3800 of these individuals for an additional 4.5 years to determine whether random assignment to an intensive lifestyle intervention focused on weight loss achieved through healthy eating and increased physical activity relative to a control group leads to improved long-term health in later life. This extended follow-up will provide important information about the long-term beneficial effects of a lifestyle intervention in a growing segment of the population-namely those who are older, overweight or obese, and have type 2 diabetes.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK057178-19
Application #
9223686
Study Section
Special Emphasis Panel (ZDK1-GRB-6 (J1)S)
Program Officer
Evans, Mary
Project Start
1999-09-30
Project End
2021-01-31
Budget Start
2017-02-01
Budget End
2018-01-31
Support Year
19
Fiscal Year
2017
Total Cost
$319,147
Indirect Cost
$57,850
Name
Columbia University (N.Y.)
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
621889815
City
New York
State
NY
Country
United States
Zip Code
10032
Brinkley, Tina E; Anderson, Andrea; Soliman, Elsayed Z et al. (2018) Long-Term Effects of an Intensive Lifestyle Intervention on Electrocardiographic Criteria for Left Ventricular Hypertrophy: The Look AHEAD Trial. Am J Hypertens 31:541-548
Gregg, Edward W; Lin, Ji; Bardenheier, Barbara et al. (2018) Impact of Intensive Lifestyle Intervention on Disability-Free Life Expectancy: The Look AHEAD Study. Diabetes Care 41:1040-1048
Murphy, Cara M; Rohsenow, Damaris J; Johnson, Karen C et al. (2018) Smoking and weight loss among smokers with overweight and obesity in Look AHEAD. Health Psychol 37:399-406
Espeland, Mark A; Carmichael, Owen; Hayden, Kathleen et al. (2018) Long-term Impact of Weight Loss Intervention on Changes in Cognitive Function: Exploratory Analyses from the Action for Health in Diabetes Randomized Controlled Clinical Trial. J Gerontol A Biol Sci Med Sci 73:484-491
Pilla, Scott J; Dotimas, James R; Maruthur, Nisa M et al. (2018) Changes in metformin use and other antihyperglycemic therapies after insulin initiation in patients with type 2 diabetes. Diabetes Res Clin Pract 139:221-229
Espeland, Mark A; Carmichael, Owen; Yasar, Sevil et al. (2018) Sex-related differences in the prevalence of cognitive impairment among overweight and obese adults with type 2 diabetes. Alzheimers Dement 14:1184-1192
Pacanowski, Carly R; Linde, Jennifer A; Faulconbridge, Lucy F et al. (2018) Psychological status and weight variability over eight years: Results from Look AHEAD. Health Psychol 37:238-246
Pilla, Scott J; Yeh, Hsin-Chieh; Juraschek, Stephen P et al. (2018) Predictors of Insulin Initiation in Patients with Type 2 Diabetes: An Analysis of the Look AHEAD Randomized Trial. J Gen Intern Med 33:839-846
Espeland, Mark A; Dutton, Gareth R; Neiberg, Rebecca H et al. (2018) Impact of a Multidomain Intensive Lifestyle Intervention on Complaints About Memory, Problem-Solving, and Decision-Making Abilities: The Action for Health in Diabetes Randomized Controlled Clinical Trial. J Gerontol A Biol Sci Med Sci 73:1560-1567
Hayden, Kathleen M; Baker, Laura D; Bray, George et al. (2018) Long-term impact of intensive lifestyle intervention on cognitive function assessed with the National Institutes of Health Toolbox: The Look AHEAD study. Alzheimers Dement (Amst) 10:41-48

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