跳至主要内容
临床试验/NCT02290171
NCT02290171已完成不适用

Promoting Health in Healthy Living Centres - a Clinical Study Among Famililies With Overweight Children

Eivind Meland4 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2014年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
152
试验地点
4
主要终点
Iso-BMI

研究概览

简要总结

The overall aim is to evaluate if a familybased intervention, targeting overweight and obese children and their parents, has a long-term positive effect on weight development and health of the children. The alternative hypothesis to the zero hypothesis is that the children with overweight and obesity who participate in a one-year intervention together with their parents, both at completion of the six months intervention and at long term follow up will have reduced their BMI-for-age z-score (Iso-BMI) and have adopted healthy habits. The behavioral models and educational strategies will be tailored (by age, gender etc.) and include both general information and practical learning sessions.

详细描述

The investigators intend to perform a controlled clinical trial on interventions on a systemic level.

The target group is overweight and obese children between 6 and 10 years old, their parents, community administrators and public health nurses. The overall aim is to evaluate if a familybased intervention, targeting overweight and obese children and their parents, has a long-term positive effect on weight development of the children. The alternative hypothesis to the zero hypothesis is that the children with overweight and obesity who participate with their parents, both at completion of the six months intervention and at long term follow up (2 years) will have reduced their BMI-for-age z-score (Iso-BMI). The behavioral models and educational strategies will be tailored (by age, gender etc.) and include both general information and practical learning sessions. The program will offer guided active play, defined as spontaneous gross locomotor movement in which children engage to amuse and to occupy themselves.

Parents will attend to workshops intending to increase knowledge and awareness of family structure, healthy eating habits and practical suggestions for implementing healthy behaviors into everyday life. Parents will be educated on how to use these strategies at home, to further support their children in improving their behaviors. This community based study is the support by the local leadership and collaboration with locally based sports clubs. The primary outcome variable, child BMI-for-age z-score will be measured at referral, inclusion, after 6 months, and at 1 and 2 years post intervention. Secondary outcome variables, measured at inclusion and at the end of intervention, are child activity pattern, screen viewing time, eating habits, sleeping patterns and body composition as well as parent BMI, body composition, exercise habits, perception of health, experience of parenthood and level of parental stress.

Physical activity level as well as sleep duration and -quality will be recorded using biaxial accellerometers. A validated food diary will be used. The participants will also be asked to complete a questionnaire including questions about screen viewing time, self-perceived healt, sleeping patterns (children) and perceived autonomy support and autonomous regulations (parents).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Iso-BMI>25,
  • able to participate in activity groups

排除标准

  • Children being unable to participate in activity groups,
  • parents not able to participate in group based and individual counseling

研究组 & 干预措施

Intervention group

Active Comparator

The intervention groups start the intervention 6 months ahead of the control group.

干预措施: Activity groups (Behavioral)

Intervention group

Active Comparator

The intervention groups start the intervention 6 months ahead of the control group.

干预措施: Group based dietary counselling (Behavioral)

Intervention group

Active Comparator

The intervention groups start the intervention 6 months ahead of the control group.

干预措施: Individual counselling (Behavioral)

Delayed intervention group

No Intervention

The control groups will start intervention with 6 months delay

结局指标

主要结局

Iso-BMI

时间窗: Change at 6 months, 1 year, 2 years

Measure change at 6 month controlled study, and at 1 and 2 years to measure long-term effects

次要结局

  • Physical activity level(6 months, 1 and 2 years)
  • Self-perceived health(6 months, 1 and 2 years)
  • Dietary habits(6 months, 1 and 2 years)

研究者

发起方
Eivind Meland
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Eivind Meland

Professor

University of Bergen

研究点 (4)

Loading locations...

相似试验

Promoting Health in Healthy Living Centres - a... | 临床试验