Lifestyle Intervention Program in Overweight Medical Students

NCT03636581 | Completed DMC

• 1 other identifier: BHS-1333
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight

Outcome Measures

Primary Outcomes (1)

• Body fat percentage

  Body composition

  4 months

Secondary Outcomes (7)

• Step Count

  4 months

• Resting Metabolic Rate

  4 months

• Total Cholesterol

  4 months

• High Density Lipoproteins

  4 months

• Low Density Lipoproteins

  4 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Lifestyle counseling BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York Institute of Technology: lead

Study Sites (1)

New York Institute of Technology

Old Westbury, New York, 11568, United States

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

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

Study Officials

• Joanne Donoghue

  New York Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 17, 2018
• Study Start: August 8, 2018
• Primary Completion: April 25, 2021
• Study Completion: April 25, 2021
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)