Skip to main content
Clinical Trials/NCT03636581
NCT03636581
Completed
Not Applicable

A Novel Lifestyle Intervention Program to Improve Body Composition and Chronic Disease Bio Markers in Overweight Medical Students: a Randomized Cross-over Trial

New York Institute of Technology1 site in 1 country40 target enrollmentAugust 8, 2018
ConditionsOverweight

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Overweight
Sponsor
New York Institute of Technology
Enrollment
40
Locations
1
Primary Endpoint
Body fat percentage
Status
Completed
Last Updated
4 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 8, 2018
End Date
April 25, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joanne DiFrancisco-Donoghue

Assistant Professor

New York Institute of Technology

Eligibility Criteria

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)

Study Sites (1)

Loading locations...

Similar Trials