Overweight Clinical Trial
Official title:
Obesity/Overweight in Persons With Early and Chronic SCI: A Randomized Multi-Center Controlled Lifestyle Intervention
Verified date | February 2016 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United States | University Of Miami | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body mass | 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. | 12 months | Yes |
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