Evaluating the Efficacy of the Feeding Exercise Trial in Adolescents (FETA Project) in Central Greece
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 181
- 主要终点
- Weight
研究概览
简要总结
The Feeding-Exercise Trial in Adolescents (FETA) was a randomised controlled intervention study designed to promote healthy weight in overweigh and obese adolescents through a professional-delivered, community-based program with active parents' involvement, focused on supervised physical activity and structured nutritional education. The aim of FETA was to test the efficacy of two intervention groups- physical activity in isolation and combination of physical activity with provision of dietary information- for improving overweight and obesity in adolescents. Our primary hypothesis was that a combined program would be more efficacious than activity in isolation and that activity alone would also be effective compared to control group in improving adiposity profiles in overweight and obese adolescents as well as family activity and feeding habits.
详细描述
Study design:
All students from the 15 public middle schools in the city of Larissa in central Greece were invited to measure their weight and height, in order to calculate their Body Mass Index (BMI). All the overweight or obese students were invited to take part in the study. The participation was free of charge for the children. Parents were informed about the purposes of the project and were asked to provide written informed consent for participation. The study's protocol was approved by the ethics committee of the Medical Department of the University of Thessaly.
One hundred eighty one adolescents were enrolled and randomized in the three groups of the study, by the same professional teacher of physical education who conducted the program. One hundred fifty remained the end of the program and the 6-months follow up and were included in the analysis. None of the subjects had an organic cause for his/her obesity and none received any medication, which would interfere with growth or weight control (e.g. corticosteroids, thyroid hormone).
Intervention:
The FETA project involved one control and two intervention groups: a Physical Activity Skill Development Program (Activity) and a combination of a Dietary Information and a Physical Activity Skill Development Program (Diet and Activity).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •None of the subjects had an organic cause for his/her obesity and
- •none received any medication, which would interfere with growth or weight control (e.g. corticosteroids, thyroid hormone).
排除标准
- •subjects who had an organic cause for his/her obesity
- •subjects who received any medication, which would interfere with growth or weight control
结局指标
主要结局
Weight
时间窗: change from baseline at 3 months intervention program
Change in weight (kilograms)
Body Mass Index (BMI)
时间窗: change from baseline at 3 months intervention program
Change in BMI (kg/m2)
Heart rate
时间窗: change from baseline at 3 months intervention program
Change in heart rate (beats per minute)
Blood Pressure
时间窗: change from baseline at 3 months intervention program
Change in Blood Pressure (mm Hg)
Waist circumference
时间窗: change from baseline at 3 months intervention program
Change in waist circumference (cm)
50m sprint Run Test
时间窗: change from baseline at 3 months intervention program
Change in 50m sprint Run Test (seconds)
Height
时间窗: change from baseline at 3 months intervention program
Change in height (meters)
Family Eating and Activity Habits
时间窗: change from baseline at 3 months intervention program
Change in \<\<Family Eating and Activity Habits\>\> (sum of the items)
次要结局
- Weight(Change from Baseline at 6 months (follow up))
- Family Eating and Activity Habits(Change from Baseline at 6 months (follow up))
- Waist circumference(Change from Baseline at 6 months (follow up))
- Body Mass Index (BMI)(Change from Baseline at 6 months (follow up))
- Height(Change from Baseline at 6 months (follow up))
- Heart Rate(Change from Baseline at 6 months (follow up))
- Blood Pressure(Change from Baseline at 6 months (follow up))
- 50m sprint Run Test(Change from Baseline at 6 months (follow up))
研究者
Hadjichristodoulou Christos
Professor of Hygiene and Epidemiology
University of Thessaly