Physical and Cognitive Function - Look AHEAD Ancillary Study

Wake Forest University (WFU)

Status: Completed

Conditions: Weight Loss; Cognitive Function; Physical Function; Diabetes

Treatments: Behavioral: Diabetes Support Education; Behavioral: Lifestyle intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01410097

IRB00008777

R01AG033087 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 1,089 patients

Sex: All

Ages: 45 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,089 participants in 2 patient groups, including a placebo group

Lifestyle intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Lifestyle intervention

Diabetes Support and Education (DSE)

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Diabetes Support Education