The Activity School in Finnmark for Overweight Children
2014年12月11日 更新者：University Hospital of North Norway
The Activity School in Finnmark for Overweight and Obese Children and Their Families
The purpose of this study is to evaluate the effectiveness of a life style counseling programme designed for overweight and obese children and their parents in groups compared to traditional individual counseling in the pediatric outpatient clinic and the community.
The two interventions are both hospital and community based.
研究概览
详细说明
Randomized study design with two parallel groups.Active intervention in two years, last follow-up after 3 years.
研究类型
介入性
注册 (实际的)
97
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Hammerfest、挪威、9600
- Childrens departement Finnmark Hospital, Norway
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
6年 至 12年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Overweight or obese.
- BMI > IOTF (International Obesity TaskForce) cut-points 27,5. kg/ m2.
Exclusion Criteria:
- Diseases not compatible with normal physical activity.
- Disorders not compatible with group treatment.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Group intervention
Lifestyle counseling (physical activity and dietary modification) in groups both at the hospital and in their own municipality.
They meet a multidisciplinary team, receive organized physical activity in the municipality and are invited to a 3 days camp after 4-6 months.
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The activity school in Finnmark. Lifestyle counseling (physical activity and dietary modification) in groups both at the hospital and in their own municipality. They meet a multidisciplinary team, receive organized physical activity in the municipality and are invited to a 3 days camp after 4-6 months.
Conventional lifestyle counseling individually by single health professionals, both in hospital and in municipality.
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有源比较器：Individual intervention
Lifestyle counseling for each separate family practiced by single health professionals both in hospital and municipality.
A more conventional model.
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Conventional lifestyle counseling individually by single health professionals, both in hospital and in municipality.
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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 |
|---|---|---|
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Change in Body Mass Index compared to baseline
大体时间：3 years
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BMI will be measured at baseline and at 3 months- , 1 year-, 2 year- and 3-year follow-up.
Primary measures at 2 years of continuous lifestyle modification.
Last measurement at 1 year after last counselling and active treatment has stopped, 3 years from baseline.
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3 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Systolic Blood Pressure compared to baseline
大体时间：3 years
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Measured with an automated blood pressure monitor at baseline, at 3 months- , 1 year-, 2 year- and 3-year follow-up.
Primary measures at the end (2 years) of continuous lifestyle modification.
Last measurement at 1 year after last counseling and active treatment has stopped, 3 years from baseline.
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3 years
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Change in Body fat compared to baseline
大体时间：3 years
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Measured with bioelectrical impedance analysis at baseline and at 3 months- , 1 year-, 2 year- and 3-year follow-up.Primary measures at 2 years of continuous lifestyle modification.
Last measurement at 1 year after last counseling and active treatment has stopped, 3 years from baseline.
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3 years
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Change in activity level / Counts per min compared to baseline
大体时间：3 years
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Measured with accelerometers at baseline, 1 year-, 2 year- and 3-year follow-up.
Primary measures at 2 years of continuous lifestyle modification.
Last measurement at 1 year after last counseling and active treatment has stopped, 3 years from baseline.
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3 years
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Change in Waist circumference compared to baseline
大体时间：3 years
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Measured with measuring tape mid-point between the lowest rib and the top of the iliac crest at baseline, 3 months- , 1 year-, 2 year- and 3-year follow-up.
Primary measures at 2 years of continuous lifestyle modification.
Last measurement at 1 year after last counseling and active treatment stopped, 3 years from baseline.
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3 years
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Change in Homa Score / HOMA IR compared to baseline
大体时间：3 years
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Homa score calculated from the cross product of fasting plasma insulin and plasma glucose divided with a factor of 22.5.
Fasting plasma insulin and glucose will be measured at baseline, at 1 year-, 2 year- and 3-year follow-up.
Primary measures at 2 years of continuous lifestyle modification.Last measurement at 1 year after last counseling and active treatment has stopped, 3 years from baseline.
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3 years
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Change in triceps skinfold compared to baseline
大体时间：3 years
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Measured with Holtain Tanner /Whitehouse Skinfold Caliper at baseline,3 months- , 1 year-, 2 year- and 3-year follow-up.
Primary measures at 2 years of continuous lifestyle modification.Last measurement at 1 year after last counseling and active treatment has stopped, 3 years from baseline.
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3 years
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Change in self-concept compared to baseline
大体时间：3 years
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Measured with SPPC, Self Perception Profile for Children at baseline, at 6 months- , 1 year-, 2 year- and 3-year follow-up.
Primary outcome measured at 2 years of continuous lifestyle modification.
Last measurement at 1 year after last counseling and active treatment has stopped.
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3 years
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Change in psychiatric health compared to baseline
大体时间：3 years
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Measured with Strengths and difficulties Questionnaire ( SDQ-S)at baseline, at 6 months- , 1 year-, 2 year- and 3-year follow-up.
Primary measurement at 2 years of continuous lifestyle modification.
Last measurement at 1 year after last counseling and active treatment has stopped.
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3 years
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Change in fitness from baseline
大体时间：3 years
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Measured with Andersen's test (shuttle test) at baseline, 1 year-, 2 year- and 3-year follow-up.
Primary measures at 2 years of continuous lifestyle modification.
Last measurement at 1 year after last counseling and active treatment has stopped, 3 years from baseline.
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3 years
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Change in quality of life compared to baseline
大体时间：3 years
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Measured with KINDL (Kinder Lebensqualitet Fragebogen) at baseline, 6 months-, 1 year-, 2 year- and 3-year follow-up.
Primary measures at 2 years of continuous lifestyle modification.
Last measurement at 1 year after last counseling and active treatment has stopped, 3 years from baseline.
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3 years
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in lipid levels compared to baseline
大体时间：3 years
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Measurements of total cholesterol, Triglycerides, HDL and LDL at baseline, 1 year-, 2 year- and 3-year follow-up.
Primary measures at 2 years of continuous lifestyle modification.
Last measurement at 1 year after last counseling and active treatment has stopped, 3 years from baseline
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3 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 学习椅：Trond Flægstad, Professor、UNorth Norway
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Kokkvoll A, Grimsgaard S, Odegaard R, Flaegstad T, Njolstad I. Single versus multiple-family intervention in childhood overweight--Finnmark Activity School: a randomised trial. Arch Dis Child. 2014 Mar;99(3):225-31. doi: 10.1136/archdischild-2012-303571. Epub 2013 Dec 11.
- Kokkvoll A, Grimsgaard S, Steinsbekk S, Flaegstad T, Njolstad I. Health in overweight children: 2-year follow-up of Finnmark Activity School--a randomised trial. Arch Dis Child. 2015 May;100(5):441-8. doi: 10.1136/archdischild-2014-307107. Epub 2014 Nov 20.
- Kokkvoll AS, Grimsgaard S, Flaegstad T, Andersen LB, Ball GDC, Wilsgaard T, Njolstad I. No additional long-term effect of group vs individual family intervention in the treatment of childhood obesity-A randomised trial. Acta Paediatr. 2020 Jan;109(1):183-192. doi: 10.1111/apa.14916. Epub 2019 Jul 30.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年4月1日
初级完成 (实际的)
2012年12月1日
研究完成 (实际的)
2013年12月1日
研究注册日期
首次提交
2009年3月30日
首先提交符合 QC 标准的
2009年3月30日
首次发布 (估计)
2009年3月31日
研究记录更新
最后更新发布 (估计)
2014年12月12日
上次提交的符合 QC 标准的更新
2014年12月11日
最后验证
2012年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.