Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI)
Condition: Overweight; Obese; Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to determine how exercise and nutritional guidance and
      supplementation affects your physical fitness, risk for heart disease, your body's ability to
      burn fat, and your opinions about your health.
    

Detailed description: 
      The study plan will enroll 80 persons with Spinal Cord Injury (SCI) who are overweight/obese
      and have fasting atherogenic dyslipidemia and dysglycemia. A Data Safety Management Board
      will oversee the trial. Interventions will include 6 months of structured lifestyle
      intervention incorporating education, exercise, diet, and behavioral support A second arm
      will test benefits of exercise alone while controlling for investigator contact. Multiple
      baselines tested before intervention will serve as a treatment control.

      Exercise will include a six-month circuit resistance training program already established as
      effective in fitness attainment for persons with paraplegia and tetraplegia. Dietary
      intervention over the same period will balance caloric expenditure measured by indirect
      calorimetry and food intake, the latter coming from a Mediterranean style diet having
      effectiveness established in the DPP for durable weight loss and diabetes prevention. The
      investigators and personal 'lifestyle coaches' will then shape and follow client-specific
      exercise and diet programs to be conducted for 12 months in the home or community-based
      centers. Behavioral approaches will include a 16-week training curriculum presented in both
      small groups and with the lifestyle coaches. Other behavioral approaches will include
      customized trial information booklets, performance incentives, outcome challenges between
      centers, and use of the VA Telehealth system for performance tracking, compliance assessment,
      and motivational support.

      Study specific aims and their accompanying hypotheses will test effects of intervention on:
      1) reducing body weight and radiographically-derived body fat, 2) improving fitness as
      assessed by endurance, strength, and anaerobic power, 3) reducing risks of fasting
      dyslipidemia, post-prandial lipemia, and insulin resistance, and 4) enhancing perceived
      health-related quality of life. Data will be analyzed by Multivariate analysis with repeated
      measures. Ancillary testing will investigate effects of intervention on the whole body
      oxidation of fat at rest and following food intake, and examine the relationship between
      dietary intake and caloric expenditure at the beginning and the end of the 18 month study.
      The primary trial goal pays fidelity to the DPP by targeting sustained loss of 7% of body
      weight, a proven countermeasure for prevention of diabetes. Positive results of training will
      represent the first evidence-based randomized multi-center trial of sustained weight loss in
      persons with SCI - military or civilian. In the near term the data will provide evidence
      needed to initiate health reform of military and non-military constituencies with disability.
      The information will also underwrite changes in dietary support of newly injured persons. The
      information will further provide a roadmap for clinicians to institute client-centered
      programs of health planning and recovery. As the extension phase will test both home and
      community-based programs, deployment to wider military constituencies of persons with SCI can
      be achieved through VA Community Outpatient Clinics. The trial can also become a roadmap to
      weight and disease management experience by persons with physical impairments other than SCI.
    

Intervention name(s): Lifestyle Intervention; Exercise Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention incorporates 6 months of active structured lifestyle intervention containing participant education, exercise, dietary intervention, and behavioral support; The control group intervention will test benefits of exercise alone while controlling for investigator contact.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: body mass; abdominal fat; whole body lean mass; insulin resistance; caloric intake; expenditure; endurance; Strength; TC:HDL ratio; LDL:HDL ratio; area under the TG response curve; feeding challenge; fasting and post-prandial whole body fat oxidation; HRQoL