Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI)

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.

Inclusion Criteria:

- participants will include 64 men and women aged 18-65 years with SCI (AIS A-C) at the
C5-L1 levels for more than 1 year.

- the International Standards for Neurological Classification of SCI (ASIA/ISCoS) will
serve as benchmarks for subject classification. A physician-rater experienced in
these procedures will classify subjects upon study entry.

Exclusion Criteria:

Study candidates will be excluded from study because of:

- structured exercise conditioning for recreation or competition within 6 months of
study entry;

- defined diet involving caloric restriction or nutrient modification;

- weight loss or gain of 5% within the preceding 6 months;

- surgery within 6 months;

- pressure ulcer within 3 months;

- upper limb pain that limits exercise;

- recurrent acute infection or illness requiring hospitalization or IV antibiotics;

- pregnancy;

- previous MI or cardiac surgery;

- 6 month history of glucose-lowering and lipid-lowering drug therapy;

- Type I or II diabetes (by WHO criteria); and

- daily intake of vitamin supplements exceeding 100% RDA.