Lifestyle Intervention Program in Overweight Medical Students

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03636581
• Other study ID #: BHS-1333
• Status: Completed
• Phase: N/A
• Start date: August 8, 2018
• Est. completion date: April 25, 2021

Study information

• Verified date: January 2022
• Source: New York Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Overweight

Intervention

Behavioral:
• Lifestyle counseling
This group will receive online education modules to educate them on exercise prescription, nutrition and behavioral changes.

Locations

Country	Name	City	State
United States	New York Institute of Technology	Old Westbury	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

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