Cooperative Lifestyle Programs (CLIP-II)
Condition: Cardiovascular Disease; Obesity; Physical Disability
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The aim is to study the effects of weight loss and weight loss combined with different types
      of physical activity on changes in physical functioning of older adults who are at-risk for
      cardiovascular disease.
    

Detailed description: 
      Although aerobic exercise training (AT) has been the cornerstone of rehabilitation for
      patients with CVD or MetS, experts agree that with the escalating problem of obesity,
      prevention programs in this area need to target weight loss (WL) as well. This is reinforced
      by recent research of our own showing that obesity is a major risk factor for physical
      disability among older adults. From a translational perspective, clinical researchers have
      recommended that effective community partnerships are needed to deliver such programs. In
      response to this call, the investigators have recently completed a translational study funded
      by NHLBI, the Cooperative Lifestyle Intervention Program (CLIP). In this investigation, 288
      obese, older adults with CVD or MetS were randomized to a successful aging control treatment
      (SA), AT, or AT+WL for 18-months. The primary outcome was mobility disability, assessed by
      performance on the 400 m Walk Test (400MWT), and our staff co-delivered the interventions
      with agents from 3 counties within the community infrastructure of North Carolina Cooperative
      Extension Centers. Whereas mobility improved significantly in the AT group compared to SA,
      AT+WL was superior to either SA or AT.

      Building on CLIP, the investigators now propose to increase the translational significance of
      our interventions by having them delivered exclusively by community partners with our staff
      as "trainers and advisers" for desired behavior change. In addition, this study will provide
      the first large scale randomized controlled clinical trial to evaluate the effects of
      diet-induced weight loss (WL) on mobility in obese, older adults with CVD or the MetS as
      compared to WL combined with physical activity. The dual primary outcomes will be the 400MWT
      and muscle strength. Because uncertainty exists about the best approach for promoting WL in
      older adults due to concerns with the loss of lean mass, the design also permits a contrast
      between AT+WL and resistance exercise training (RT)+WL on muscle strength. Consistent with
      CLIP, our WL intervention will target a protein intake of 0.8 g∙kg body mass-1∙d-1. Reasons
      to consider RT+WL for older adults include: 1) the central role of muscle loss and decline in
      strength in mobility disability; 2) the underappreciated role of RT in cardiovascular health;
      3) the influence of muscle mass on both resting and total energy expenditure as well as fat
      mass and bone health; and 5) the potential value of RT for improving mobility on tasks that
      depend heavily on the vertical movement of the center of mass (e.g., stair climbing). Eves
      and Plotnikoff22 have emphasized the importance of RT in older diseased populations and
      stated that "the investigators need to discover practical, sustainable, and economically
      viable ways to safely implement RT at the population level." To accomplish our goals, the
      investigators have created a community partnership with the YMCA, using 4 sites in Forsyth
      County, NC. One of the sites serves a large African American population. The investigators
      are moving this project from Cooperative Extension Centers to the YMCA because the former
      have neither the equipment nor the personnel necessary to independently train and monitor RT
      or AT.
    

Intervention name(s): Caloric restriction; Aerobic Training; Resistance Training
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Caloric restriction; Walking; Lifting weights
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment