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Physical and Cognitive Function - Look AHEAD Ancillary Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Pennington Biomedical Research Center
University of Colorado, Denver
University of Tennessee
University of Pittsburgh
Information provided by (Responsible Party):
Stephen Kritchevsky, Ph.D., Wake Forest University
ClinicalTrials.gov Identifier:
NCT01410097
First received: July 8, 2011
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Diabetes
Weight Loss
Physical Function
Cognitive Function
 Behavioral: Lifestyle intervention
Behavioral: Diabetes Support Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Intentional Weight Reduction and Physical and Cognitive Function - A Look AHEAD Ancillary Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wake Forest University:

Primary Outcome Measures:
  • SPPB [ Time Frame: These participants will have one visit at their year 8 or 9 of main study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 400 m walk [ Time Frame: These participants will have one visit at their year 8 or 9 of main study ] [ Designated as safety issue: No ]
  • Grip Stength [ Time Frame: These participants will have one visit at their year 8 or 9 of main study ] [ Designated as safety issue: No ]
  • Knee extensor strength [ Time Frame: These participants will have one visit at their year 8 or 9 of main study ] [ Designated as safety issue: No ]
  • Trail Making Test (A & B) [ Time Frame: These participants will have one visit at their year 8 or 9 of main study ] [ Designated as safety issue: No ]
  • Digit Symbol Substitution Test (DSST) [ Time Frame: These participants will have one visit at their year 8 or 9 of main study ] [ Designated as safety issue: No ]
  • Rey Auditory Verbal Learning Test (AVLT) [ Time Frame: These participants will have one visit at their year 8 or 9 of main study ] [ Designated as safety issue: No ]
  • Modified Stroop Test [ Time Frame: These participants will have one visit at their year 8 or 9 of main study ] [ Designated as safety issue: No ]
  • Modified Mini-Mental Status Exam (3MS) [ Time Frame: These participants will have one visit at their year 8 or 9 of main study ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: September 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Behavioral: 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.
Placebo Comparator: 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.
 Behavioral: 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

Ages Eligible for Study:   45 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410097

Locations
United States, Colorado
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70801
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15203
United States, Tennessee
The University of Tennessee-Memphis
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
Wake Forest University
Pennington Biomedical Research Center
University of Colorado, Denver
University of Tennessee
University of Pittsburgh
Investigators
Principal Investigator: Stephen B Kritchevsky, PhD Wake Forest University
  More Information

Additional Information:
Main Look AHEAD Trial's website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Stephen Kritchevsky, Ph.D., Professor, Wake Forest University
ClinicalTrials.gov Identifier: NCT01410097     History of Changes
Other Study ID Numbers: R01 AG033087
Study First Received: July 8, 2011
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013