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临床试验/NCT03636581
NCT03636581已完成不适用

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

New York Institute of Technology2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年8月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Body fat percentage

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Body fat percentage

时间窗: 4 months

Body composition

次要结局

  • High Density Lipoproteins(4 months)
  • Low Density Lipoproteins(4 months)
  • Resting Metabolic Rate(4 months)
  • Total Cholesterol(4 months)
  • Triglycerides(4 months)
  • Hemoglobin A1C(4 months)
  • Step Count(4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joanne DiFrancisco-Donoghue

Assistant Professor

New York Institute of Technology

研究点 (2)

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