Lifestyle Intervention for Senior Diabetics
Condition: Diabetes Mellitus; Aging; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Older people with diabetes will be assigned to the 1-year lifestyle program or no lifestyle
      program while continuing usual treatment for diabetes. The lifestyle program will consist of
      teaching how to practice healthy diet and regular exercise at our facility and continued into
      the community and home. It is hoped that the results would provide convincing proof about the
      usefulness of lifestyle change in older patients with diabetes.
    

Detailed description: 
      Background: Hypothesis: Lifestyle intervention will be highly successful in the population of
      older adults with diabetes, with resultant significant improvement in glycemic metabolic
      control mediated by improved insulin action/secretion, accompanied by significant
      improvements in physical function, cognitive function, and quality-of-life (QOL).

      Rationale: Countering the prevailing notion that it is difficult to change lifelong habits,
      the PI has ample preliminary data showing successful lifestyle change in older adults. A
      similar lifestyle intervention augmented by motivational interviewing might also be
      successful in older adults with diabetes with eventual translation to the community- and
      home-settings.

      Aims: In older adults with diabetes and comorbidities, the aims are to: determine the effect
      of lifestyle intervention on glycemic metabolic control, determine the mechanisms underlying
      lifestyle-induced changes in glucose homeostasis, and determine the effect of lifestyle
      intervention on age-relevant health outcomes: physical function, cognitive function, QOL.

      Design: Older adults with diabetes and comorbidities will be randomized to center-based
      lifestyle intervention continued into the community and home vs. healthy-lifestyle control
      for 1 year.

      Relevance to diabetes prevention and treatment: Data from a randomized-controlled trial will
      provide high-level evidence to convince practitioners to implement lifestyle intervention as
      the primary therapy for diabetes in older patients.
    

Intervention name(s): Weight loss and Exercise; Healthy lifestyle
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Group behavior therapy sessions designed to acquire positive weight-control skills and attitudes, and practice weight-maintenance skills. A balanced diet will be prescribed to provide a deficit of 500-750 kcal/day from daily energy requirement.
Exercise sessions of ~90 min duration 15 min warm-up of flexibility exercise, followed by ~30 min of aerobic exercise, and, after a brief rest period, ~30 min of resistance training, and finally ~15 min balance exercise) conducted three times weekly supervised at our exercise facility for first six months, and regular exercises continued at community-fitness centers and at home for the following six months.; Diabetes support and education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment