跳至主要内容
临床试验/NCT00916318
NCT00916318Unknown不适用

Overweight and Obesity in Preschool Children, Prevalence and Prevention - Family Based Health Interventions for Child Health

Vardalinstitutet The Swedish Institute for Health Sciences1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2008年8月1日最近更新:
适应症

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

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)

研究者

发起方
Vardalinstitutet The Swedish Institute for Health Sciences
申办方类型
Other

研究点 (1)

Loading locations...

相似试验