Clinical trial NCT01410097: Physical and Cognitive Function - Look AHEAD Ancillary Study
Official title: Intentional Weight Reduction and Physical and Cognitive Function - A Look AHEAD Ancillary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Weight Loss
Physical Function
Cognitive Function
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Pennington Biomedical Research Center
name: University of Colorado, Denver
name: University of Tennessee
name: University of Pittsburgh
name: National Institute on Aging (NIA)
First posted: 2011-08-04
Enrollment: 1089
Sex: ALL
Minimum age (years): 45
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Obesity is associated with physical disability through both direct pathways (e.g., lower extremity pain, insufficient muscle strength) and indirect pathways (obesity-related comorbidities and inflammation). Furthermore, diabetes, a major obesity-related health condition, is associated with increased risk of disability and accelerated declines in physical and cognitive function. The investigators preliminary data suggest that intentional weight loss improves physical function, and there is strong circumstantial evidence that it would also benefit cognitive function.

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.


Eligibility criteria: Inclusion Criteria:

* The only inclusion criterion is that the participant is considered "active" at his/her Year 8 or Year 9 visit in the main study.

Exclusion Criteria:

* The only exclusion criterion is the person is not willing to participate in this ancillary study.

Primary outcomes:
measure: Short Physical Performance Battery (SPPB) Score
timeFrame: Assessed 8 or 9 years post-randomization in Look AHEAD parent Study
Secondary outcomes:
measure: Gait Speed Over 400 m
timeFrame: Assessed 8 or 9 years post-randomization in Look AHEAD parent Study
measure: Grip Strength
timeFrame: Assessed 8 or 9 years post-randomization in Look AHEAD parent Study
measure: Knee Extensor Strength
timeFrame: Assessed 8 or 9 years post-randomization in Look AHEAD parent Study
measure: Trail Making Test (Part A & B)
timeFrame: Assessed 8 or 9 years post-randomization in Look AHEAD parent Study
measure: Digit Symbol Substitution Test (DSST)
timeFrame: Assessed 8 or 9 years post-randomization in Look AHEAD parent Study
measure: Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: Assessed 8 or 9 years post-randomization in Look AHEAD parent Study
measure: Modified Stroop Color and Word Test
timeFrame: Assessed 8 or 9 years post-randomization in Look AHEAD parent Study
measure: Modified Mini-Mental Status Exam (3MS)
timeFrame: Assessed 8 or 9 years post-randomization in Look AHEAD parent Study
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Memphis
country: United States
facility: The University of Tennessee-Memphis
state: Tennessee
Study officials:
affiliation: Wake Forest University Health Sciences
name: Stephen B Kritchevsky, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.