Pediatrician-lead Motivational Counselling to Control BMI in Overweight Children: a RCT in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 372
- 试验地点
- 2
- 主要终点
- BMI variation from baseline
研究概览
简要总结
Obesity is one of the leading causes of morbidity and mortality in the industrialised world. Evidence is growing that early life nutrition can play a role in behavioural and cognitive problems in children and adolescents and is well documented that being overweight and obese during childhood can have short- and long-term physical and psycho-social health implications.
This is an individually randomised trial to evaluate the efficacy of a family pediatrician-lead counselling intervention in reducing the BMI of over-weight children aged 4-7 years old. As secondary objectives the investigators evaluate the effect of the counselling on dietary behaviours and physical activity.
The investigators targeted the intervention to overweight children, while obese children were referred to specialised care. The counselling targeted diet, physical activity, and sedentary behaviours.
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
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •overweight children with BMI percentile between 85° and 94°
- •4-7 years old
- •resident in Reggio Emilia Province
- •assisted by the pediatrician at least for 12 months
排除标准
- •metabolic pathologies and all pathologies related with obesity
- •family in pre-contemplation stage
结局指标
主要结局
BMI variation from baseline
时间窗: 12 months
Difference between 12-month BMI score (weight/heigh2) and time-0 BMI score. Intervention average and control average BMI score are compared by Wilcoxon-Mann Whitney Test.
次要结局
- Physical Activity behaviors variations(12 months)
- Diatary behaviors variations(12 month)