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Lifestyle Intervention Program in Overweight Medical Students

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03636581
Recruitment Status : Active, not recruiting
First Posted : August 17, 2018
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Joanne DiFrancisco-Donoghue, New York Institute of Technology

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
Overweight Behavioral: Lifestyle counseling Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : August 8, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Body fat percentage [ Time Frame: 4 months ]
    Body composition


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03636581


Locations
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United States, New York
New York Institute of Technology
Old Westbury, New York, United States, 11568
Sponsors and Collaborators
New York Institute of Technology
Investigators
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Principal Investigator: Joanne Donoghue New York Institute of Technology
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Responsible Party: Joanne DiFrancisco-Donoghue, Assistant Professor, New York Institute of Technology
ClinicalTrials.gov Identifier: NCT03636581    
Other Study ID Numbers: BHS-1333
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight