Prevention of Weight Gain in Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change in weight from baseline between the two groups over a two-year intervention period (0, 3, 6, 12, 18 and 24 months).
研究概览
简要总结
The purpose of the present study is to determine whether weight gain may be prevented by a small group seminar-based two-year educational intervention on healthy lifestyle in freshmen at the Faculté de médecine de l'Université de Sherbrooke.
详细描述
This is a 2-year randomized, controlled intervention study to test the effectiveness of a small group seminar-based educational intervention on healthy lifestyle to prevent weight gain in young healthy university students.
Hypothesis : We hypothesize that a small group seminar-based educational intervention on healthy lifestyle may prevent weight gain in young healthy adults.
PROTOCOL:
Recrutment of participants : First and second year students will be recruted at the 'Faculté de médecine et des sciences de la santé' of the University of Sherbrooke.
A pre-randomisation visit will be performed to verify eligibility and exclusion criteria and to perform the following:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being first or second year in one of the Baccalaureate programs of the Faculté de médecine de l'Université de Sherbrooke.
- •Aged between 18 and 30 years old
- •BMI between 18 and 30 kg/m2
- •Having left parental house less than one year ago
排除标准
- •Planned pregnancy or pregnancy occurring during the two-year follow up
- •Chronic medical condition that may affect weight present before or occurring during the two-year follow up.
- •Use of any medication other than birth control pills.
结局指标
主要结局
Change in weight from baseline between the two groups over a two-year intervention period (0, 3, 6, 12, 18 and 24 months).
Change in BMI from baseline between the two groups over a two-year intervention period (0, 3, 6, 12, 18 and 24 months).
次要结局
- Change in fat free mass (by bioimpedance) over follow up between the two groups.
- Change in waist circumference over follow up between the two groups.
- Change in non-fat free mass over follow up between the two groups.
- Change in dietary intake (by 3-day food records) over follow up between the two groups.
- Change in physical activity level (by questionnaire) over follow up between the two groups.
- Change in physical fitness level (by the Canadian Home Fitness Test) over follow up between the two groups.
- Change in plasma lipid profile (plasma total cholesterol, triglycerides, LDL and HDL cholesterol) over follow up between the two groups.
- Change in circulating hormones and inflammatory markers (insulin, leptin, adiponectin, C-reactive protein, Interleukin-6) over follow up between the two groups.
- Relation between change in weight and energy intake and expense in the overall cohort.
- Relation between change in weight and fitness level in the overall cohort.
- Relation between change in weight and metabolic parameters (lipids, hormones and inflammatory markers) in the overall cohort