The problem of obesity addressed by this proposal represents a serious and worsening health hazard for persons with spinal cord injuries (SCI). Military directives and public policy have brought this problem to the forefront of health priorities for both the military and civilian populations. To address these directives and policies, the overarching study objective is to reduce health hazards from being overweight or obese, and from disorders such as Type 2 Diabetes Mellitus in people with SCI, and to improve their life quality. This four-year multi-center randomized clinical trial will be conducted at two SCI rehabilitation research centers and two VA Medical Centers. The lifestyle intervention undergoing study is modeled after the Diabetes Prevention Program (DPP), a federally sponsored multi-center trial that achieved a sustained 7% body weight reduction in pre-diabetic individuals and a 58% decrease in their progression to Type-2 diabetes. The lifestyle intervention approach incorporating diet, exercise, and behavioral adjustments was more effective than drug therapy, benefited both genders and persons of all races, and has lasted 10 years after initiation.

The study plan will enroll 64 persons with SCI who are overweight or obese, and have fasting lipid and glucose levels outside of reference ranges. Interventions will include either six months of structured lifestyle intervention including diet, exercise and behavioral support, or exercise with behavioral support but no diet. A 3-month non-intervention period with multiple measurements will serve as a treatment control.

Exercise will include a circuit resistance training program we have already established as effective for fitness attainment for persons with paraplegia and tetraplegia. Dietary intervention will match calories from food intake and exercise, and will resemble a Mediterranean-style diet already established in the DPP as effective for near-term and sustained weight loss and diabetes prevention. The investigators and personal "Lifestyle Coaches" will shape and carefully follow client-specific lifestyle intervention or exercise programs for 6 months, and then follow with less monitoring for another 12 months while the treatments are performed 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 Lifestyle Manuals, performance incentives, outcome challenges between centers, and use of the VA Telehealth system for performance tracking, compliance assessment, and motivational support.

Study specific aims will compare effects of both interventions and the placebo on: (1) reducing body weight and body fat, (2) improving fitness as assessed by endurance, strength, and power, (3) reducing risks of fasting lipids, blood lipids after eating, and insulin resistance, and (4) enhancing perceived health-related quality of life. Data will be analyzed by comparing measurements at multiple time points among the three test conditions. We will also investigate effects of intervention on the burning of body fat while at rest and following food intake. The primary trial goal, like that of the DPP, targets a sustained loss of 7% of body weight, a proven countermeasure for prevention of diabetes.

Positive results of training will represent the first compelling evidence for sustained weight loss in persons with SCI -- military or civilian. In the near term, the information 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 and the existing VA TeleHealth Network. The trial can also become a roadmap to weight and disease management experienced by persons with physical impairments other than SCI.