Exercise and Behavioral Therapy in Obese Children
Exercise Training and Family-based Behavioural Treatment in Pre-pubertal Obese Children and Their Mother
調査の概要
詳細な説明
Introduction: The prevalence of childhood obesity is increasing rapidly in developing countries. The aim of this study is to determine the effects of exercise training and family-based behavioral treatment (FBBT), either in individual or in group setting,in pre-pubertal children and their mother.
Methods: This is a 6-month randomized controlled trial (RCT) including 75 pre-pubertal obese children (age 8-11 years) randomly assigned to an Intervention (I, n=50) or a Control group (C, n=25). The intervention consists of a family-based behavioural therapy in group (1 session/week with a dietician and a psychologist) or in individual setting (paediatrician or dietician 1x/month). The intervention includes exercise training sessions twice a week (60 minutes each).
Measures include: body mass index (BMI), waist and hip circumferences; whole body and abdominal fat mass by DXA; resting and ambulatory blood pressure; arterial intima-media thickness and vascular reactivity (flow-mediated dilation)using high resolution ultrasound; arterial stiffness by tonometry of applanation; cardiorespiratory fitness by a treadmill test; physical activity; fasting lipids, glucose, insulin, and C-reactive protein levels; health-related quality of life and psychological health using standardized questionnaires and a semi-structured interview. Measures are completed in children and their mother at baseline and 6 months post-randomization.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Geneva、スイス、1205
- University Hospital of Geneva
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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:
- Childhood obesity (>97 percentile WHO references)
Exclusion Criteria:
- being involved in any weight control, physical activity, behavior therapy, or gastric surgery program;
- familial history of dyslipidemia or essential hypertension;
- medications or hormones, which may influence cardiovascular function, body composition, lipid or glucose metabolism in the preceding 6 months;
- orthopaedic affection limiting physical activity;
- genetic disorder or another chronic disease;
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：処理
- 割り当て：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 |
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介入なし：コントロール
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実験的：Family-based behavioral therapy
Family-based behavioural therapy either in group or in individual setting.
Parents can choose between the 2 types of therapy.
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The intervention consist of a 6-month family-based behavioural therapy either in group (1 session/week, with a dietician and a psychologist) or in individual setting (with a paediatrician or a dietician in alternance 1x/month).
Both therapies include exercise training twice per week (60 minutes each).
Parents, or at at least the mother, must participate to the behavioral treatment.
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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 at 6 months
時間枠：6 months
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Body Mass Index (weight/height 2) expressed in Standard Deviation Score
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6 months
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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 total body and abdominal fat at 6 months
時間枠：6 months
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Body fat mass and percentage assessed using DXA
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6 months
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Change from baseline in waist circumference at 6 months
時間枠：6 months
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6 months
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Change from baseline in blood pressure at 6 months
時間枠：6 months
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Resting and ambulatory (24 hours) systolic and diastolic blood pressure
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6 months
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Change from baseline in arterial intima-media thickness at 6 months
時間枠：6 months
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Measure of the arterial intima-media thickness using high-resolution ultrasound
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6 months
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Change from baseline in arterial flow-mediated dilation at 6 months
時間枠：6 months
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Measure of the flow-mediated dilation of the brachial artery using high-resolution ultrasound
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6 months
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Change from baseline in arterial stiffness at 6 months
時間枠：6 months
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Measure of mechanical indices using tonometry of applanation
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6 months
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Change from baseline in cardiorespiratory fitness at 6 months
時間枠：6 months
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6 months
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Change from baseline in physical activity at 6 months
時間枠：6 months
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Physical activity pattern using accelerometer
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6 months
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Change from baseline in biological markers at 6 months
時間枠：6 months
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Fasting glucose, insulin, total-, LDL-, HDL-cholesterol, high-sensitive C-reactive protein.
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6 months
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Change from baseline in quality of life at 6 months
時間枠：6 months
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Quality of life assessed using the Kidsscreen 52 questionnaire
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6 months
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Change from baseline in child's behavior at 6 months
時間枠：6 months
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Child Behavior Checklist filled by parents
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6 months
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Change from baseline in parental psychological health at 6 months
時間枠：6 months
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Global Health Questionnaire filled by parents
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6 months
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協力者と研究者
捜査官
- 主任研究者：Nathalie Farpour-Lambert, MD、University of Geneva
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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