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Lifestyle Intervention Program in Overweight Medical Students

Sponsor
New York Institute of Technology (Other)
Overall Status
Completed
CT.gov ID
NCT03636581
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
32.6
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Lifestyle counseling
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 8, 2018
Actual Primary Completion Date :
Apr 25, 2021
Actual Study Completion Date :
Apr 25, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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
This group will receive online education modules to educate them on exercise prescription, nutrition and behavioral changes.
No Intervention: Control

This group will receive a smart watch to track activity only with no intervention.

Outcome Measures

Primary Outcome Measures

  1. Body fat percentage [4 months]

    Body composition

Secondary Outcome Measures

  1. Step Count [4 months]

    Activity based on step count

  2. Resting Metabolic Rate [4 months]

    Resting metabolic rate changes as per oxygen consumption

  3. Total Cholesterol [4 months]

    fasting serum mg/dL

  4. High Density Lipoproteins [4 months]

    fasting serum mg/dL

  5. Low Density Lipoproteins [4 months]

    fasting serum mg/dL

  6. Triglycerides [4 months]

    fasting serum mg/dL

  7. Hemoglobin A1C [4 months]

    fasting plasma % of total hemoglobin

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 New York Institute of Technology Old Westbury New York United States 11568

Sponsors and Collaborators

  • New York Institute of Technology

Investigators

  • Principal Investigator: Joanne Donoghue, New York Institute of Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joanne DiFrancisco-Donoghue, Assistant Professor, New York Institute of Technology
ClinicalTrials.gov Identifier:
NCT03636581
Other Study ID Numbers:
  • BHS-1333
First Posted:
Aug 17, 2018
Last Update Posted:
Jan 18, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Overweight

Study Results

No Results Posted as of Jan 18, 2022