Promoting Health in Healthy Living Centres - a Clinical Study Among Children
Promoting Health in Healthy Living Centres - a Clinical Study Among Famililies With Overweight Children
研究概览
地位
条件
详细说明
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).
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Hordaland
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Bergen、Hordaland、挪威、5018
- University of Bergen
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Vest-Agder
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Kristiansand、Vest-Agder、挪威、4604
- University of Agder
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Iso-BMI>25,
- able to participate in activity groups
Exclusion Criteria:
- Children being unable to participate in activity groups,
- parents not able to participate in group based and individual counseling
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Intervention group
The intervention groups start the intervention 6 months ahead of the control group.
|
Children attend to activity groups weekly during the intervention periode.
Parents attend to four sessions of group based dietary counselling
Parents attend to individual counselling focusing on parental skills and family structure
|
|
无干预:Delayed intervention group
The control groups will start intervention with 6 months delay
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Iso-BMI
大体时间: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
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Change at 6 months, 1 year, 2 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Physical activity level
大体时间:6 months, 1 and 2 years
|
Measure at the end of the 6 month controlled study, and at 1 and 2 years to measure long-term effects.
We will use SenseWear bi-axial accelerometer to mesa sure physics activity.
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6 months, 1 and 2 years
|
|
Dietary habits
大体时间:6 months, 1 and 2 years
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Measure at the end of the 6 month controlled study, and at 1 and 2 years to measure long-term effects.
We will use a specially designed questionnaire to measure dietary habits.
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6 months, 1 and 2 years
|
|
Self-perceived health
大体时间:6 months, 1 and 2 years
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Measure at the end of the 6 month controlled study, and at 1 and 2 years to measure long-term effects.
We will use KidScreen 10 questionnaire to measure self-perceived health.
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6 months, 1 and 2 years
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Autonomous regulation and perceived autonomy support
大体时间:6 months, 1 and 2 years
|
Measure at the end of the 6 month controlled study, and at 1 and 2 years to measure long-term effects.
We will use Treatment Self-regulation Questionnaire to measure autonomous regulation, and Healt Care Climate Questionnaire to measure autonomy support.
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6 months, 1 and 2 years
|
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Motor skills
大体时间:6 months, 1 and 2 years
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Measure at the end of the 6 month controlled study, and at 1 and 2 years to measure long-term effects.
We will use Kôrper-koordinationstest fur Kinder to measure motor skills.
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6 months, 1 and 2 years
|
合作者和调查者
调查人员
- 首席研究员:Eivind Meland, MD, PhD、Dept of Glob Publ Health and Primary Care, University of Bergen
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- NCT02290171
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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