A Novel Lifestyle Intervention Program to Improve Body Composition and Chronic Disease Bio Markers in Overweight Medical Students: a Randomized Cross-over Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Body fat percentage
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Body fat percentage
Time Frame: 4 months
Body composition
Secondary Outcomes
- High Density Lipoproteins(4 months)
- Low Density Lipoproteins(4 months)
- Resting Metabolic Rate(4 months)
- Total Cholesterol(4 months)
- Triglycerides(4 months)
- Hemoglobin A1C(4 months)
- Step Count(4 months)
Investigators
Joanne DiFrancisco-Donoghue
Assistant Professor
New York Institute of Technology