Overweight and Obesity in Preschool Children, Prevalence and Prevention - Family Based Health Interventions for Child Health
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Primary Outcome Measure: BMI
研究概览
简要总结
To evaluate the effects of a family-based intervention program intended for parents of pre-school children (4-6 y) with overweight and obesity (according to Cole et al), and to investigate if treatment has an effect on metabolic parameters. In a randomised controlled trial evaluate the three separate family based intervention programs and to investigate if treatment has an effect by correlating the parameters described above with BMI, before and after the intervention program.
详细描述
The aim is to investigate the possibility of preventing the development of obesity in early childhood. To evaluate the effects of a family-based intervention program intended for parents of pre-school children (4-6 y) with overweight and obesity (according to Cole et al), and to investigate if treatment has an effect on metabolic parameters. To compare different methods of treatment by randomizing the families into groups with various treatment during one year; (A) internet based information and communication tool "Sundabarn.se"(B) psychologist directed seminars with different themes, giving parents tools to implement necessary changes in family-patterns and life style, combined with A, (C) occupational therapist directed group-treatment intended to help parents alter their daily life patterns and, combined with A, (D) control group. To analyse the aetiology and prognosis of overweight and obesity in early childhood, by measuring the following variables: heredity, genetics, perinatal, physiological, metabolism, bio-chemical, clinical, psychological, socio-economic. In a randomised controlled trial evaluate the three separate family based intervention programs and to investigate if treatment has an effect by correlating the parameters described above with BMI, before and after the intervention program. To calculate the prevalence of overweight and obesity among pre-school children in the county of Middle Skåne during a 20 year period. To analyse parents actual utilization of the Sundabarn.se and in association with primary and secondary outcome. To analyse the cost-effectiveness of the intervention programs.
The primary outcome variable, BMI of the children, is measured at inclusion, after six months, at exclusion and one year after end of program.
Following variables are investigated and related to BMI of children before and after intervention: Heredity: BMI of parents, history . Socio-economic background: education, salary, language, occupation of parents. Perinatal data: Mothers BMI, parity, smoking, ponderal index of infant, gender, breast-feeding. Psychological variables: grading of parents experienced stress and control and psychological health of the child, before end after intervention. Are there a correlation between change in these factors and change in BMI of the child after the intervention? Physiological variables: Sleep duration and activity patterns in the children and compare them to BMI Analysing sleep duration and activity with an accelerometer. Analysing dietary of children: diet registration Analysing the change of bio-chemical markers in blood of children before and after intervention: metabolism of insulin (glc, insulin, C-peptide, pro-insulin, HBA1C) lipids (TG, HDL, LDL, cholesterole), adipokins and cytokins (leptin, adinopektin, resistin, haptoglobulin, IL-6, TNFalfa),ghrelin before and after a meal, thyroid (TSH, T3). Analysing the bacteria of the gastro-intestinal tract by sample from stools.
Utilization of SundaBarn.se: automatic, electronic measurement by single user identity of number of sessions, pages visited, inputs made and downloads.
Intervention health-care resource use: Protocol driven visits to physician, nurse, occupational therapist, psychologist, dietitian.
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
- 4 Years 至 5 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI due to Cole criteria as overweight or obesity
排除标准
- •Medical disorders
- •Endocrine disorders
结局指标
主要结局
Primary Outcome Measure: BMI
时间窗: 6 months, 1 year, 2 year, 5 year
次要结局
- Secondary Outcome Measures: diet registration Analysing the change of bio-chemical markers in blood of children before and after intervention(6 months, 1 year, 2 year, 5 year)
