Physical and Cognitive Function - Look AHEAD Ancillary Study
Condition: Diabetes; Weight Loss; Physical Function; Cognitive Function
MeSH terms: Weight Loss
Study type: Interventional

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.
    


Intervention name(s): Lifestyle intervention; Diabetes Support Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; It offers an educational program to participants including developing support groups. Providing such benefits helps retain these participants in the trial.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention