Chronic Conditions in Childhood Obesity Subject: An Mixed Methods Research Approach
調査の概要
詳細な説明
Background: Childhood obesity is a global "public health crisis" with increasing prevalence rate in all racial, ethnic and gender groups, as well as across socioeconomic strata. Research findings indicate that over the past 30 years, the prevalence of chronic conditions in children and youths has increased. Childhood obesity impacts physical, psychological and social well-being, and also impacts the economy as well.
Purpose: The purpose of this study is to explore the healthy status, healthy lifestyles among school-age obese children of chronic conditions, then to examine the contextual factors affecting their healthy lifestyles, in order to develop a theory-informed and evidence-based intervention of school-based and family-involved intervention for obese children, and evaluate the effectiveness of interventions by using mixed methods (MM) research approach.
Methods: This study will be a three-year mixed methods study, including the identification of obesity issues among children with chronic conditions in the first phase study (2013/10/01-2014/07/31), development of an intervention protocol in the second phase study (2014/08/01-2015/07/31), and conduction/evaluation of an intervention of lifestyle intervention in the third phase study (2015/08/01-2016/07/31). Firstly, anthropometry, healthy lifestyles questionnaire survey on children aged 7-12 and school environment audit will be conducted. By using the literature review, meta-analysis and focus-research approaches to develop a healthy lifestyle intervention protocol in the second year program. The protocol will be tested on a sample of school-age children with asthma, to develop a school-based and family-involved healthy lifestyle intervention. Finally, the protocol will be undertaken on children with asthma aged 10-15, by using an experimental (pretest-posttest) design with repeated follow-ups. The research subjects will be randomly assign to condition of receiving intervention or control; the measurement of the outcome across 4 observations, to assess both group differences (experimental comparison), and changes within groups. The interventions consist of healthy diet (X1), regular exercise (X2), and booster energy balance-related behaviors (BEBRB) (X3). The observations start from baseline (O1), then have three observations (O2, O3, O4) at 3-month interval respectively. Outcome indicators include height, body weight, waist circumference as well as healthy life style modification present by diet record, exercise diary, healthy life environments. The research subjects will consist of randomly sampled school-age children and their fathers (or mothers), school teachers and school nurses. The approximate sample size is estimated by power analysis and dropout rate, the eligible sample size will be 200 and 160 pairs of children with their parents, school teachers and nurses in the first and third year respectively.
Expected outcomes: To recognize the risk factors and determinants, have an evidence-based development of school-based and family-involved lifestyle modification to better health outcomes for children with chronic conditions.
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
-
-
-
Taipei、台湾
- 募集
- National Taiwan University
-
コンタクト:
- Bih-Shya Gau, Ph.D
- 電話番号:88440 886+23123456
- メール:bsgau@ntu.edu.tw
-
-
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:
- 7~15years old child
- 7~15years old child's caregiver
- 7~15years old child's teacher
- 7~15years old child's nurse
Exclusion Criteria:
- not 7~15years old child
- not 7~15years old child's caregiver
- not 7~15years old child's teacher
- not 7~15years old child's nurse
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:なし
- 介入モデル:単一グループの割り当て
- 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 |
|---|---|
|
実験的:lifestyle intervention
the intervention strength (amount, frequency, duration) including a reduction in energy intake and an increase in physical activity level will be reported.
The guidance/description of the treatment protocol, preparation and training of intervener, techniques to retain the research subjects will be covered to prevent the lack of intervention integrity.
Besides, the schooler admitted in a university hospital will be invited to explore their health lifestyles and receive the intervention.
|
the intervention strength (amount, frequency, duration) including a reduction in energy intake and an increase in physical activity level will be reported.
The guidance/description of the treatment protocol, preparation and training of intervener, techniques to retain the research subjects will be covered to prevent the lack of intervention integrity.
Besides, the schooler admitted in a university hospital will be invited to explore their health lifestyles and receive the intervention.
他の名前:
|
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 |
時間枠 |
|---|---|
|
the body weight and height to calculate the body mass index (BMI)
時間枠:evaluate after intervention in 3 months
|
evaluate after intervention in 3 months
|
協力者と研究者
捜査官
- 主任研究者:Bih-Shya Gau, PhD、National Taiwan University Hospital
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
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。