Lifestyle Intervention Program in Overweight Medical Students

Study Overview
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Brief Summary
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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.

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

Conditions
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Overweight

Intervention / Treatment
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* Behavioral: Lifestyle counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>This group will receive a smart watch to track activity and diet. This group will also receive education on nutrition and exercise. | Behavioral: Lifestyle counseling<br>* This group will receive online education modules to educate them on exercise prescription, nutrition and behavioral changes.<br>|
| No Intervention: Control<br>This group will receive a smart watch to track activity only with no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body fat percentage | Body composition | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Step Count | Activity based on step count | 4 months | 
| Resting Metabolic Rate | Resting metabolic rate changes as per oxygen consumption | 4 months | 
| Total Cholesterol | fasting serum mg/dL | 4 months | 
| High Density Lipoproteins | fasting serum mg/dL | 4 months | 
| Low Density Lipoproteins | fasting serum mg/dL | 4 months | 
| Triglycerides | fasting serum mg/dL | 4 months | 
| Hemoglobin A1C | fasting plasma % of total hemoglobin | 4 months |