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Lifestyle Intervention Program in Overweight Medical Students

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle counseling
Sponsored by
New York Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • New York Institute of Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

This group will receive a smart watch to track activity and diet. This group will also receive education on nutrition and exercise.

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

Outcomes

Primary Outcome Measures

Body fat percentage
Body composition

Secondary Outcome Measures

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

Full Information

First Posted
August 14, 2018
Last Updated
January 14, 2022
Sponsor
New York Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03636581
Brief Title
Lifestyle Intervention Program in Overweight Medical Students
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 8, 2018 (Actual)
Primary Completion Date
April 25, 2021 (Actual)
Study Completion Date
April 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York Institute of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
This group will receive a smart watch to track activity and diet. This group will also receive education on nutrition and exercise.
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group will receive a smart watch to track activity only with no intervention.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counseling
Intervention Description
This group will receive online education modules to educate them on exercise prescription, nutrition and behavioral changes.
Primary Outcome Measure Information:
Title
Body fat percentage
Description
Body composition
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Step Count
Description
Activity based on step count
Time Frame
4 months
Title
Resting Metabolic Rate
Description
Resting metabolic rate changes as per oxygen consumption
Time Frame
4 months
Title
Total Cholesterol
Description
fasting serum mg/dL
Time Frame
4 months
Title
High Density Lipoproteins
Description
fasting serum mg/dL
Time Frame
4 months
Title
Low Density Lipoproteins
Description
fasting serum mg/dL
Time Frame
4 months
Title
Triglycerides
Description
fasting serum mg/dL
Time Frame
4 months
Title
Hemoglobin A1C
Description
fasting plasma % of total hemoglobin
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne Donoghue
Organizational Affiliation
New York Institute of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Institute of Technology
City
Old Westbury
State/Province
New York
ZIP/Postal Code
11568
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Lifestyle Intervention Program in Overweight Medical Students

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