Effectiveness and Cost Effectiveness of a 1-year Dietary and Physical Activity Intervention of Childhood Obesity - Study Protocol for a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To investigate the efficacy of the intervention for the ISO-BMI
研究概览
简要总结
The aim of this study is to evaluate the effects of lifestyle intervention on the management of childhood overweight and to explore the factors that contribute to the outcome, as well as the costs for the health care system. The hypotheses of the study are that lifestyle intervention is efficient in reducing BMI-SDS and thus effective in preventing overweight to progress to obesity, and it is also cost effective.
The research is necessary for the development of overweight treatment, and try to find out the optimal duration and intensity for the treatment and content useful for clinical work.
详细描述
Methods and analyses: The aim of this study is to recruit 80 children and to randomize them either to an intervention group or a control group with standard care. Intervention group receive intensive, family-based diet and physical activity counseling, deliver by a multidisciplinary team of a pediatrician, a nurse and a clinical nutritionist. Control group do not receive any lifestyle intervention during the study. The inclusion criteria are weight-for-height ≥+40% or ≥+30% and increasing and age of 6-12 years. All participants fill out the study questionnaires and plasma samples are taken at baseline and at 12 months. Outcome variables will be compared between intervention and control groups.
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
- None
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
- •weight for height at least + 40 % or ≥ 30 % and it is rising
排除标准
- •Clinical diagnosis of endocrine or mental diseases.
研究组 & 干预措施
intervention group
The 1-year lifestyle intervention includes intensive, family-based diet and physical activity counselling. The multidisciplinary team consists of one pediatrician, one specialist nurse and a clinical nutritionist. Children with their parents meet the pediatrician two times, the specialist nurse five times and the clinical nutritionist three times during the 1-year intervention. One of the meetings with the clinical nutritionist is only for parents and the child is with the nurse at the same time.
The treatment is based on educational and behavioural counselling and motivating the participants to change their lifestyle and to support the parents in managing their children´s behaviour. The aim of counselling is to increase awareness of healthy dietary and physical activity habits; to achieve a suitable energy balance, to create a positive attitude to physical activity, to promote optimal sleep duration and to improve the children´s body image and body control.
干预措施: 1-year dietary and physical activity intervention of childhood obesity (Procedure)
control group
Participants in the control group continue with the standard care in primary care and do not receive any special lifestyle intervention during the study.
结局指标
主要结局
To investigate the efficacy of the intervention for the ISO-BMI
时间窗: 12 months
How much ISO-BMI change during the intervention (kg/m2)
The costs of the intervention for the health care system
时间窗: 12 months
Investigators calculate the costs (euros) of the intervention (the price of research visits, laboratory tests, the salary of emplyees and the cost of research rooms).
次要结局
未报告次要终点
研究者
Anni Martikainen
clinical nutritionist
Helsinki University Central Hospital