Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI)
|Overweight Obese Spinal Cord Injury||Behavioral: Lifestyle Intervention Behavioral: Exercise Control|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
|Official Title:||Obesity/Overweight in Persons With Early and Chronic SCI: A Randomized Multi-Center Controlled Lifestyle Intervention|
- Body mass [ Time Frame: 12 months ]Study specific aims and their accompanying hypotheses will test effect 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. 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.
|Study Start Date:||September 2010|
|Study Completion Date:||September 2016|
|Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Experimental: Lifestyle Intervention
This arm will test the combination of 6 months of structured lifestyle intervention incorporating education, exercise, diet, and behavioral support.
Behavioral: Lifestyle Intervention
The intervention incorporates 6 months of active structured lifestyle intervention containing participant education, exercise, dietary intervention, and behavioral support
Placebo Comparator: Exercise Control
This arm will test the benefits of exercise alone while controlling for investigator contact.
Behavioral: Exercise Control
The control group intervention will test benefits of exercise alone while controlling for investigator contact.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467817
|United States, Florida|
|University Of Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Mark S Nash, PhD||University of Miami|