Overweight Clinical Trial
Official title:
A Novel Lifestyle Intervention Program to Improve Body Composition and Chronic Disease Bio Markers in Overweight Medical Students: a Randomized Cross-over Trial
NCT number | NCT03636581 |
Other study ID # | BHS-1333 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 8, 2018 |
Est. completion date | April 25, 2021 |
Verified date | January 2022 |
Source | New York Institute of Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will be a randomized cross-over design over the course of 2 academic years. 40 subjects -20 overweight women and 20 over weight men will be recruited. Each subject will have body composition tested, blood lipid profile, and resting metabolic rate done in the beginning of the first academic year and at the end of the first academic year. The intervention group will receive activity trackers, diet counseling, and fitness counseling for one academic year. The second year, all outcome measures (a body scan, blood lipid profile, and resting metabolic rate) will be performed again at the start of the academic year 2, except the intervention group will now be the control group and the control group will now receive the same intervention. All final outcome measures will be performed at the end of the second year.
Status | Completed |
Enrollment | 40 |
Est. completion date | April 25, 2021 |
Est. primary completion date | April 25, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria: - Male and female NYITCOM students between the ages of 18-35 - BMI = 25.0 - Body fat % >19% for males; >33% for women (will be determined by body composition scan) - Own their own smartphone Exclusion Criteria: - People who have used weight loss smartphone applications in the past 6 month - People who have used an activity tracker in past 6 months - Anyone who answers yes to one or more questions on the PAR-Q screen - Any contraindication to having a duel x-ray body scan performed based on the American College of Radiology's practice guidelines |
Country | Name | City | State |
---|---|---|---|
United States | New York Institute of Technology | Old Westbury | New York |
Lead Sponsor | Collaborator |
---|---|
New York Institute of Technology |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body fat percentage | Body composition | 4 months | |
Secondary | Step Count | Activity based on step count | 4 months | |
Secondary | Resting Metabolic Rate | Resting metabolic rate changes as per oxygen consumption | 4 months | |
Secondary | Total Cholesterol | fasting serum mg/dL | 4 months | |
Secondary | High Density Lipoproteins | fasting serum mg/dL | 4 months | |
Secondary | Low Density Lipoproteins | fasting serum mg/dL | 4 months | |
Secondary | Triglycerides | fasting serum mg/dL | 4 months | |
Secondary | Hemoglobin A1C | fasting plasma % of total hemoglobin | 4 months |
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