The Activity School in Finnmark for Overweight and Obese Children and Their Families
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Change in Body Mass Index compared to baseline
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of a life style counseling programme designed for overweight and obese children and their parents in groups compared to traditional individual counseling in the pediatric outpatient clinic and the community. The two interventions are both hospital and community based.
详细描述
Randomized study design with two parallel groups.Active intervention in two years, last follow-up after 3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overweight or obese.
- •BMI > IOTF (International Obesity TaskForce) cut-points 27,
排除标准
- •Diseases not compatible with normal physical activity.
- •Disorders not compatible with group treatment.
结局指标
主要结局
Change in Body Mass Index compared to baseline
时间窗: 3 years
BMI will be measured at baseline and at 3 months- , 1 year-, 2 year- and 3-year follow-up. Primary measures at 2 years of continuous lifestyle modification. Last measurement at 1 year after last counselling and active treatment has stopped, 3 years from baseline.
次要结局
- Change in Body fat compared to baseline(3 years)
- Change in activity level / Counts per min compared to baseline(3 years)
- Change in triceps skinfold compared to baseline(3 years)
- Change in self-concept compared to baseline(3 years)
- Change in Systolic Blood Pressure compared to baseline(3 years)
- Change in Homa Score / HOMA IR compared to baseline(3 years)
- Change in psychiatric health compared to baseline(3 years)
- Change in fitness from baseline(3 years)
- Change in quality of life compared to baseline(3 years)
- Change in Waist circumference compared to baseline(3 years)