Evaluation of a Family Intervention Program for the Management of Overweight or Obese Children (NEREU)
Evaluation of Family Intervention Program for the Treatment of Overweight or Obese Children (Nereu Program): Randomized Clinical Trial
Objectives: To evaluate the effectiveness of the Nereu program compared to standard care (advice on increased physical activity and nutrition) such as a health intervention tool for the childhood obesity management
Methods/Design: The study design is a randomized controlled multicenter clinical trial using two types of treatment. Population and sample: Children 6 to 12 years with overweight or obesity, according to the z score of body mass index (BMI z) >= 1 for age and gender defined by International Obesity Task Force (IOTF). It is considered necessary to recruit 100 children: 50 control group (CG) and 50 Intervention (IG). Study Intervention: Nereu Group: 8 month intervention with 3 weekly training sessions doing physical exercise for children and a weekly session for parents of physical activity and healthy eating habits and behaviour strategies, that involves both parental and child participation. The control group will receive a monthly session of healthy physical and eating habits. Main Outcome Measures: Improvement of BMI z, physical activity and nutrition habits, behaviour components and quality life related to health at the end, 6 and 12 months after intervention.
調査の概要
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究場所
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Lleida、スペイン、25001
- 募集
- USR- Lleida. Atenció primaria. IDIAP Jordi Gol
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コンタクト：
- Conxita Teixidó, Dra
- メール：cteixido.lleida.ics@gencat.cat
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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:
- Children aged between 6 to 12 years old
- Overweight or obese according to the IOTF criteria
Exclusion Criteria:
- Medical co-morbidities: Diabetes mellitus or hypercholesterolemia or cardiovascular disease that could be contraindicate the sport practice.
- Use of medication that might have an effect on weight loss.
- previous enrolment in another similar treatment program based on reducing obesity.
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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プラセボコンパレーター：Counselling Group
Each family will receive a single monthly meeting, a total of 8 with 10 minutes duration each one.
The sessions will take place in the consultation of the paediatrician and it will be delivered by the child's nurse or/and paediatrician.
The sessions' contents are about promotion of healthy eating and physical activity habits.
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実験的：Nereu Group
The Nereu treatment program is an intensive family-based behavioural multi-component lifestyle intervention.
Consist in an intensive treatment of 8 months duration (from October to May, that is, an academic year).
The intervention is a multidisciplinary intervention consisting in 4 structured components: (a) physical activity training for children, (b) family theoretical and practical sessions for parents, (c) behaviour strategies, that involves both parental and child participation (d) weekend extra activities.
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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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Change from Baseline in Body mass index z score (BMIz)
時間枠：4 times: at baseline, at the end of the intervention (8 months later of the baseline), 6 and 12 months post intervention
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Weight is measured to the nearest of 0.1 kg using an electronic scale and height (Ht) to the nearest of 0.1 cm with a stadiometer, in lightly dressed and without shoes.
The BMIz is calculated according z score of BMI adjusted by age and gender (IOTF).
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4 times: at baseline, at the end of the intervention (8 months later of the baseline), 6 and 12 months post intervention
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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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Change from baseline in Physical activity habits
時間枠：4 times: at baseline, at the end of the intervention (8 months later of the baseline), 6 and 12 months post intervention
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To measure physical activity will be used an Actigraph accelerometers (GT3X+ models), it will be wear by participants during all day for seven consecutive days.
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4 times: at baseline, at the end of the intervention (8 months later of the baseline), 6 and 12 months post intervention
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協力者と研究者
捜査官
- 主任研究者：Noemí Serra、INEFC-LLEIDA, University of Lleida
- 主任研究者：Concepció Teixidó、Institut Català de la Salut - Atenció primaria - Lleida
出版物と役立つリンク
一般刊行物
- Serra-Paya N, Ensenyat A, Castro-Vinuales I, Real J, Sinfreu-Bergues X, Zapata A, Mur JM, Galindo-Ortego G, Sole-Mir E, Teixido C. Effectiveness of a Multi-Component Intervention for Overweight and Obese Children (Nereu Program): A Randomized Controlled Trial. PLoS One. 2015 Dec 14;10(12):e0144502. doi: 10.1371/journal.pone.0144502. eCollection 2015.
- Serra-Paya N, Ensenyat A, Real J, Castro-Vinuales I, Zapata A, Galindo G, Sole-Mir E, Bosch-Munoz J, Mur JM, Teixido C. Evaluation of a family intervention programme for the treatment of overweight and obese children (Nereu Programme): a randomized clinical trial study protocol. BMC Public Health. 2013 Oct 23;13:1000. doi: 10.1186/1471-2458-13-1000.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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 (見積もり)
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
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