Physical and Cognitive Function - Look AHEAD Ancillary Study
NCT ID: NCT01410097
Last Updated: 2018-09-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1089 participants
INTERVENTIONAL
2009-09-30
2015-09-30
Brief Summary
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To evaluate the role of intentional weight loss on physical and cognitive function, the investigators propose an ancillary study to the on-going Look AHEAD (Action for Health in Diabetes) trial. Look AHEAD is a multi-center, randomized clinical trial to examine the effects of a 4-year lifestyle intervention designed to achieve and maintain weight loss through decreased caloric intake and exercise in overweight or obese men and women aged 45-74 years with type 2 diabetes. The investigators propose to add validated and well-established measures of physical and cognitive performance to the year 8 follow-up visit - during the trial's weight maintenance phase - in \~1000 participants at 4 of the 16 Look AHEAD field sites (Colorado, Memphis, Pennington and Pittsburgh).
The specific aims of this ancillary study are: 1) To determine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss on physical function; and 2) To determine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss on cognitive function. In addition, the investigators hypothesize that in the intervention group, larger initial weight loss, better weight loss maintenance, and higher physical activity will be associated with better physical and cognitive function. The investigators also hypothesize that in the control group weight loss will be associated with worse physical and cognitive function than in those who are weight stable or who have gained weight.
The number of obese older adults is rising rapidly and there are few data to guide an evidence-based clinical response to their management. The results of this study will provide the first direct evidence of the role of long-term intentional weight loss on the maintenance of physical and cognitive function in older obese adults with diabetes. Since this study is being done as an ancillary study to an on-going trial it can be done in a timely and cost-efficient manner.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Lifestyle intervention
Intensive Lifestyle Intervention that includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
Lifestyle intervention
Intensive Lifestyle Intervention that includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
Diabetes Support and Education (DSE)
It offers an educational program to participants including developing support groups. Providing such benefits helps retain these participants in the trial.
Diabetes Support Education
It offers an educational program to participants including developing support groups. Providing such benefits helps retain these participants in the trial.
Interventions
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Lifestyle intervention
Intensive Lifestyle Intervention that includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
Diabetes Support Education
It offers an educational program to participants including developing support groups. Providing such benefits helps retain these participants in the trial.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
45 Years
74 Years
ALL
No
Sponsors
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Pennington Biomedical Research Center
OTHER
University of Colorado, Denver
OTHER
University of Tennessee
OTHER
University of Pittsburgh
OTHER
National Institute on Aging (NIA)
NIH
Wake Forest University
OTHER
Responsible Party
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Principal Investigators
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Stephen B Kritchevsky, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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University of Colorado Health Sciences Center
Aurora, Colorado, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
The University of Tennessee-Memphis
Memphis, Tennessee, United States
Countries
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References
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Ip EH, Chen SH, Rejeski WJ, Bandeen-Roche K, Hayden KM, Hugenschmidt CE, Pierce J, Miller ME, Speiser JL, Kritchevsky SB, Houston DK, Newton RL, Rapp SR, Kitzman DW. Gradient and Acceleration of Decline in Physical and Cognitive Functions in Older Adults: A Disparity Analysis. J Gerontol A Biol Sci Med Sci. 2022 Aug 12;77(8):1603-1611. doi: 10.1093/gerona/glac109.
Beavers KM, Leng I, Rapp SR, Miller ME, Houston DK, Marsh AP, Hire DG, Baker LD, Bray GA, Blackburn GL, Hergenroeder AL, Jakicic JM, Johnson KC, Korytkowski MT, Dorsten BV, Kritchevsky SB; Action for Health in Diabetes Movement and Memory Ancillary Study Research Group. Effects of Longitudinal Glucose Exposure on Cognitive and Physical Function: Results from the Action for Health in Diabetes Movement and Memory Study. J Am Geriatr Soc. 2017 Jan;65(1):137-145. doi: 10.1111/jgs.14478. Epub 2016 Sep 27.
Other Identifiers
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IRB00008777
Identifier Type: -
Identifier Source: org_study_id
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