The Pitt Retiree Study: A Diabetes Prevention Program for Medicare Eligible Older Adults
Condition: Obesity; Cardiovascular Risk Factor; Eating Behavior; Diet Modification; Physical Activity; Quality of Life; Mobility Limitation
MeSH terms: Mobility Limitation
Study type: Interventional

Summary: 
      The Pitt Retiree Study (PRS) disseminates a novel, yet practical, diabetes prevention program
      among Medicare eligible adults in Western Pennsylvania. This study will provide 4, and 12
      month outcome data (with a no treatment follow-up assessment at 24 months) to help determine
      whether a continued contact group telephone intervention is feasible and effective in
      enhancing health outcomes and physical functional ability in high risk adults (aged 65-80)
      with obesity and cardiometabolic risk factors .
    

Detailed description: 
      There is substantial evidence that overweight and obesity during late life (≥ 65 years of
      age) confers significant risk for type 2 diabetes and co-morbid conditions. Thus, there is
      growing concern about the public health consequences of increased incidence of type 2
      diabetes in an aging United States population. Studies with high risk samples have shown that
      lifestyle interventions significantly reduce diabetes risk and that elders are particularly
      responsive, showing better weight loss and lower rates of diabetes development in comparison
      to younger individuals. However, although there have been program dissemination studies with
      mixed-age adult cohorts, few studies have focused specifically on persons ≥ 65 years of age
      or addressed the challenges of identifying workable platforms for delivering prevention
      programs to older adults. This application is based on the premise that offering an
      evidence-based lifestyle intervention to reduce risk for type 2 diabetes to retirees during
      the annual Medicare enrollment process presents an innovative, practical opportunity to reach
      eligible, high-risk adults. If shown to be feasible and effective, this program has strong
      potential for public health impact and medical cost-containment. Further, although clinical
      studies have emphasized the importance of continued contact over time in helping individuals
      extend the benefits of lifestyle interventions, there are no dissemination studies of which
      we are aware that have systematically documented the impact of continued monthly contacts
      after the initial intervention period. Thus, the overall aims of this application are to: 1.
      examine the feasibility and effectiveness of implementing the Group Lifestyle Balance
      12-session program (GLB-12), an evidence-supported prevention program to mitigate diabetes
      risk, as part of the Medicare benefit offered to high risk retirees at a large public
      university, and; 2. evaluate the utility of continued telephone contact in enhancing
      treatment outcome at 12-months from baseline. Eligible participants will be 320 adults
      without diabetes, aged 65-80, with a BMI ≥ 27 and at least one additional cardiometabolic
      risk factor. All participants will receive the GLB-12 and then will be randomized to one of
      two continued contact protocols for the remaining one year of intervention, 8-sessions of
      continued small group contact by telephone (GLB-12 plus 8TC) or a newsletter control
      condition (GLB-12 plus NC). Program feasibility will be assessed by reporting enrollment,
      adherence and session completion rates, and satisfaction ratings in this delivery context.
      Effectiveness of the GLB-12 will be documented by reporting mean percent weight loss and the
      proportion of participants meeting ≥ 5% weight loss, a commonly accepted benchmark in
      translation studies known to be associated with favorable cardiometabolic outcomes at month
      4. It also is hypothesized that GLB-12 plus 8TC, when compared to GLB-12 plus NC will be
      associated with more favorable anthropometric (weight, waist), cardiometabolic (glucose,
      blood pressure, lipid), physical function (chair stand, balance, gait speed) and health
      related quality of life outcomes at months 12 and 24. Finally, exploratory analyses will
      document program costs and program impact on medical utilization.
    

Intervention name(s): GLB plus phone contacts; GLB plus newsletter contacts
Intervention type(s): Behavioral; Behavioral
Intervention description(s): GLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving.; GLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: An initial (non-randomized) translational Group Lifestyle Balance (GLB) in person, lifestyle intervention designed to mitigate cardiometabolic risk in older adults is delivered to all participants between 0 and 4-months. Subsequently, one-half of the enrolled sample is randomized to either (1) 8-group telephone contacts (8-TC) for the remainder of 12-months; the other one-half is randomized to a newsletter control condition (NC) during this time period.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention