Play as a Method to Reduce Overweight and Obesity in Children. (Kids-Play)
Play as a Method to Reduce Overweight and Obesity in Children. Kids-Play Study.
Introduction Overweight and obesity are characterised by excess fat, which results in weight gain and is identified by the Body Mass Index (BMI). Studies show that overweight and obesity are the result of a complex interaction between genetic and environmental factors, which begins prenatally. Various studies have shown that physical exercise is an important component of weight loss programmes and that it also benefits the metabolic profile. Other authors have reported that greater weight loss is achieved by a programme that includes both diet and exercise, rather than either of these alone.
Aim The aim of this study is to analyse an intervention based on play as a means of improving the body composition of children with overweight or obesity.
Design / Method The design of the Kids-Play study is based on cases and controls. The study was conducted in Granada (Spain) The analysis sample of 98 children was divided into two groups: cases, consisting of 49 children, who participated in an intervention programme based on physical activity, play and nutritional advice (to both the child and the parents); and controls, another 49 children, who received only nutritional advice.
調査の概要
状態
条件
研究の種類
入学 (実際)
段階
- 適用できない
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:
- Obese children that want participate in a voluntary way in the research and sign the informed consent.
Exclusion Criteria:
- Refused to participate
- Hormonal problems
- Age < 8 or >12 years
- Orthopaedic, respiratory
- Other problems
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 |
|---|---|
|
実験的：Study group
Consisting of 49 children who were recommended a programme of physical activity, play and nutritional advice, for both the children and their parents
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The intervention consisted of physical activity based on play, with four 90-minute sessions per week for nine months (the school year).
The total of sessions was 144, the minimum number of sessions to consider valid that a child has completed the intervention was 115 (80%) in order to perform the minimum level of physical activity recommended for their ages.
In parallel, twice-monthly theoretical and practical sessions of nutritional advice were given to the children and their families.
The study group performed the physical activity and received the nutritional advice, while the control group received only the theoretical and practical sessions on nutrition.
|
|
介入なし：Control group
49 children, who received only nutritional advice
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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 |
|---|---|---|
|
Children's body composition
時間枠：12 months
|
The children's body composition was measured before and after the intervention, by bioelectrical impedance and using the InBody 720 body composition analyser.
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12 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 |
|---|---|---|
|
The level of daily physical activity
時間枠：1 month
|
The level of daily physical activity was assessed using ActiGraph wGT3X-BT accelerometers, which were worn on the right hip by all children in the study population for seven days, except during the hours of sleep.
In this way it was possible to objectively analyse whether the study group met the WHO recommended levels of activity for their age group, and to determine the differences between cases and controls.
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1 month
|
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Sleep apnea
時間枠：6 month
|
Sleep apnea has been measured by sleep polygraphy.
|
6 month
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Sanchez-Lopez AM, Menor-Rodriguez MJ, Sanchez-Garcia JC, Aguilar-Cordero MJ. Play as a Method to Reduce Overweight and Obesity in Children: An RCT. Int J Environ Res Public Health. 2020 Jan 3;17(1):346. doi: 10.3390/ijerph17010346.
- Aguilar-Cordero MJ, Rodriguez-Blanque R, Leon-Rios X, Exposito Ruiz M, Garcia Garcia I, Sanchez-Lopez AM. Influence of Physical Activity on Blood Pressure in Children With Overweight/Obesity: A Randomized Clinical Trial. Am J Hypertens. 2020 Feb 22;33(2):131-136. doi: 10.1093/ajh/hpz174.
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。