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OpenTrials
Completed

NCT Number: NCT03636581

Lifestyle Intervention Program in Overweight Medical Students

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Institute of Technology

Old Westbury, New York, 11568, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Counseling

Behavioral

This group will receive online education modules to educate them on exercise prescription, nutrition and behavioral changes.

Primary outcomes

  1. Body fat percentage

    Time frame: 4 months

    Body composition

Secondary outcomes

  1. Step Count

    Time frame: 4 months

    Activity based on step count

  2. Resting Metabolic Rate

    Time frame: 4 months

    Resting metabolic rate changes as per oxygen consumption

  3. Total Cholesterol

    Time frame: 4 months

    fasting serum mg/dL

  4. High Density Lipoproteins

    Time frame: 4 months

    fasting serum mg/dL

  5. Low Density Lipoproteins

    Time frame: 4 months

    fasting serum mg/dL

  6. Triglycerides

    Time frame: 4 months

    fasting serum mg/dL

  7. Hemoglobin A1C

    Time frame: 4 months

    fasting plasma % of total hemoglobin

Sponsors and collaborators

Lead sponsor

New York Institute of Technology

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 17, 2018
Registry last updated
Jan 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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