Physical and Cognitive Function - Look AHEAD Ancillary Study

NCT01410097 | Completed Results

• 2 other identifiers: IRB00008777R01AG033087
• Study Type: interventional
• Target: 1,089
• Locations: 1 country
• Sites: 4

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.

Conditions

Diabetes; Weight Loss; Physical Function; Cognitive Function

Outcome Measures

Primary Outcomes (1)

• Short Physical Performance Battery (SPPB) Score

  The Short Physical Performance Battery (SPPB) was administered to assess lower extremity physical performance and consisted of standing balance tasks (side-by-side, semi- and full-tandem stands for 10 seconds each), time to complete 5 repeated chair stands, and a 6-m walk to assess usual gait speed. Each of the three performance measures was assigned a score ranging from 0 (inability to perform the task) to 4 (the highest level of performance) and summed to create an SPPB score ranging from 0 to 12 (best). Assessed 8 or 9 years post-randomization in Look AHEAD parent Study.

  Assessed 8 or 9 years post-randomization in Look AHEAD parent Study

Secondary Outcomes (8)

• Gait Speed Over 400 m

  Assessed 8 or 9 years post-randomization in Look AHEAD parent Study

• Grip Strength

  Assessed 8 or 9 years post-randomization in Look AHEAD parent Study

• Knee Extensor Strength

  Assessed 8 or 9 years post-randomization in Look AHEAD parent Study

• Trail Making Test (Part A & B)

  Assessed 8 or 9 years post-randomization in Look AHEAD parent Study

• Digit Symbol Substitution Test (DSST)

  Assessed 8 or 9 years post-randomization in Look AHEAD parent Study

Study Arms (2)

Lifestyle intervention

EXPERIMENTAL

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.

Behavioral: Lifestyle intervention

Diabetes Support and Education (DSE)

PLACEBO COMPARATOR

It offers an educational program to participants including developing support groups. Providing such benefits helps retain these participants in the trial.

Behavioral: Diabetes Support Education

Interventions

Lifestyle intervention BEHAVIORAL

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

Diabetes Support Education BEHAVIORAL

It offers an educational program to participants including developing support groups. Providing such benefits helps retain these participants in the trial.

Diabetes Support and Education (DSE)

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Wake Forest University: lead
• Pennington Biomedical Research Center: collaborator
• University of Colorado, Denver: collaborator
• University of Tennessee: collaborator
• University of Pittsburgh: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (4)

University of Colorado Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70801, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15203, United States

Location

The University of Tennessee-Memphis

Memphis, Tennessee, 38105, United States

Location

Related Publications (2)

• 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.

  PMID: 35562076 DERIVED

• 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.

  PMID: 27676466 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Weight Loss

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Stephen B. Kritchevsky, PhD
• Organization: Wake Forest University

skritche@wakehealth.edu

336-713-8548

Study Officials

• Stephen B Kritchevsky, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2011
• First Posted: August 4, 2011
• Study Start: September 1, 2009
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 10, 2018
• Results First Posted: November 17, 2017

Record last verified: 2018-08

Locations

US (4)