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
調査の概要
詳細な説明
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).
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Hordaland
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Bergen、Hordaland、ノルウェー、5018
- University of Bergen
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Vest-Agder
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Kristiansand、Vest-Agder、ノルウェー、4604
- University of Agder
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ:Intervention group
The intervention groups start the intervention 6 months ahead of the control group.
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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
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介入なし:Delayed intervention group
The control groups will start intervention with 6 months delay
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Iso-BMI
時間枠:Change at 6 months, 1 year, 2 years
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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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Physical activity level
時間枠: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 SenseWear bi-axial accelerometer to mesa sure physics activity.
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6 months, 1 and 2 years
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Dietary habits
時間枠: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
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Self-perceived health
時間枠: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
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Autonomous regulation and perceived autonomy support
時間枠: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 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
時間枠: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
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Eivind Meland, MD, PhD、Dept of Glob Publ Health and Primary Care, University of Bergen
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- NCT02290171
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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