Families and Schools for Health (FiSH)
2016年1月14日 更新者:Amanda Harrist
Intervening in Family and Peer Contexts to Decrease Child Overweight
The purpose of the study is to test the effectiveness of a child obesity intervention with multiple components targeting nutrition and/or psycho-social factors in children, their parents, and their classmates.
The specific aims of the study are to (1) Determine the effectiveness of two family-level interventions for improving child outcomes (unhealthy eating, low activity, and overweight); (2) Determine the extent to which adding a family dynamics component enhances the effectiveness of a family lifestyle intervention and improves the child outcomes listed above; and (3) Determine the extent to which a peer-level intervention improves the effectiveness of two family-level interventions among overweight children.
調査の概要
詳細な説明
The Families and Schools for Health (FiSH) Project evaluates a psychosocial intervention that targets the family and peer contexts of overweight children.
23 rural schools were identified for participation (schools within a 90-mile radius of the PI's campus were targeted) and each was assigned to one of five intervention conditions using stratified random sampling, with stratification based on proximity to each other (to avoid spill-over effects) and proportion of Native American Indian students.
A community sample of 1186 1st grade children, their families, and their teachers were successfully recruited.
Anthropometric assessments were conducted with the 1186 children.
Those who were not at Control schools were invited to participate in the intervention.
541 children qualified for the intervention (i.e., had BMI% > 75%), including 459 at Intervention schools and 82 at Control schools.
Intervention conditions were (1) a 12-week Family Food & Lifestyle intervention (FL), aimed at improving family nutritional intake, activity levels, weight perception, and parental monitoring of child eating; (2) a 12-week Family Food & Lifestyle and Family Dynamics intervention (FL+FD) that additionally targets dysfunctional family patterns such as high conflict, poor parent-child communication, and parental over-control or permissiveness; and (3) a Peer Group (PG) intervention conducted throughout one semester of the school year that includes a guidance-type curriculum sensitizing children to the importance of social inclusion of all children.
Thus, 5 treatment groups were evaluated in the intervention year and followed through 4th grade: FL, FL+FD, FL+PG, FL+FD+PG, and Control.
Child psychosocial variables such as emotional eating, self-esteem, loneliness, and social withdrawal will be analyzed as mediators between family/peer contexts and child overweight.
研究の種類
介入
入学 (実際)
541
段階
- 適用できない
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Children with BMI% greater than or equal to 75% who were enrolled in first grade in participating schools.
Exclusion Criteria:
- Children with BMI% < 75%.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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:階乗代入
- 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 |
---|---|
実験的:Family Lifestyle (FL; n = 117)
This arm includes the Family Food & Lifestyle intervention (FL).
Parents and children meet for 12 weekly, 90-minute psychoeducational groups in children's schools.
They meet separately for 45 minutes and then conjointly for 45 minutes.
|
12-week Family Food & Lifestyle intervention, aimed at improving family nutritional intake, activity levels, weight perception, and parental monitoring of child eating.
Material is delivered in psychoeducational groups in the children's schools.
|
実験的:FL + Family Dynamics (FL+FD; n = 88)
This arm includes the Family Food & Lifestyle + Family Dynamics interventions (FL+FD).
Parents and children meet separately for the full 90-minute psychoeducation sessions.
The first 45 minutes are devoted to the Family Food & Lifestyle intervention and the second 45 minutes to the Family Dynamics intervention.
|
12-week Family Food & Lifestyle intervention, aimed at improving family nutritional intake, activity levels, weight perception, and parental monitoring of child eating.
Material is delivered in psychoeducational groups in the children's schools.
The Family Dynamics intervention focuses on positive parenting (i.e., emotion coaching, praise, limit setting) and on child emotion regulation and positive problem solving.
Material is delivered in psychoeducational groups in the children's schools.
|
実験的:FL + Peer Group (FL+PG; n = 124)
This arm includes the Family Food & Lifestyle intervention plus the 12-session, Peer Group intervention.
|
12-week Family Food & Lifestyle intervention, aimed at improving family nutritional intake, activity levels, weight perception, and parental monitoring of child eating.
Material is delivered in psychoeducational groups in the children's schools.
Peer Group intervention conducted throughout one semester of the school year that includes 12 sessions of a guidance-type curriculum during class time sensitizing children to the importance of social inclusion of all children
|
実験的:FL + FD + Peer Group (FL+FD+PG; n = 130)
This arm includes the Family Food & Lifestyle intervention plus the Family Dynamics Intervention plus the Peer Group intervention.
|
12-week Family Food & Lifestyle intervention, aimed at improving family nutritional intake, activity levels, weight perception, and parental monitoring of child eating.
Material is delivered in psychoeducational groups in the children's schools.
The Family Dynamics intervention focuses on positive parenting (i.e., emotion coaching, praise, limit setting) and on child emotion regulation and positive problem solving.
Material is delivered in psychoeducational groups in the children's schools.
Peer Group intervention conducted throughout one semester of the school year that includes 12 sessions of a guidance-type curriculum during class time sensitizing children to the importance of social inclusion of all children
|
介入なし:Control (n = 82)
Non-intervention control group
|
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 |
---|---|---|
Body Mass Change from Baseline to End of 1st grade
時間枠:Wave 2, Spring Year 1
|
Height and weight measured at Wave 2 (Spring 1st grade), vs. Baseline at Fall 1st grade
|
Wave 2, Spring Year 1
|
Body Mass Change from Baseline to End of 2nd grade
時間枠:Wave 3, Spring Year 2
|
Height and weight measured at Wave 3 (Spring 2nd grade), vs. Baseline at Wave 1, Fall 1st grade
|
Wave 3, Spring Year 2
|
Body Mass Change from Baseline to End of 3rd grade
時間枠:Wave 4, Spring Year 3
|
Height and weight measured at Wave 4 (Spring 3rd grade), vs. Baseline at Wave 1, Fall 1st grade
|
Wave 4, Spring Year 3
|
Body Mass Change from Baseline to End of 4th grade
時間枠:Wave 5, Spring Year 4
|
Height and weight measured at Wave 5 (Spring 4th grade) vs. Baseline at Wave 1, Fall 1st grade
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Wave 5, Spring Year 4
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Parent perceived responsibility, weight, child weight, concerns about weight, feeding practices - parent report
時間枠:Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
|
Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
|
Parent expectations about, parent modeling of, and parent perception of child beliefs regarding eating - parent report
時間枠:Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
|
Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
|
Family problem solving, communication, affective responsiveness, affective involvement, & general family functioning - parent report
時間枠:Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
|
Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
|
Parenting style (permissive, authoritative, authoritarian) - parent report
時間枠:Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
|
Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
|
Parent response to child negative emotions - parent report
時間枠:Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
|
Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
|
Child temperament - child and parent report
時間枠:Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
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Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
|
Child emotion management - Parent and child report
時間枠:Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
|
Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
|
Child behavior problems - Parent and teacher report (externalizing, internalizing)
時間枠:Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
|
Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
|
School climate
時間枠:Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
|
Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
|
Peer relations - child, peer, and teacher reports
時間枠:Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
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Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
|
Child emotional and external eating - child self report
時間枠:Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
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Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
|
Body esteem - child self report
時間枠:Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
|
Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
|
Child self esteem - child self report
時間枠:Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
|
Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
|
Child depressive symptoms - child self report
時間枠:Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
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Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者:Amanda W Harrist, PhD、Oklahoma State University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Harrist AW, Swindle TM, Hubbs-Tait L, Topham GL, Shriver LH, Page MC. The Social and Emotional Lives of Overweight, Obese, and Severely Obese Children. Child Dev. 2016 Sep;87(5):1564-80. doi: 10.1111/cdev.12548. Epub 2016 May 25.
- Shriver LH, Hubbs-Tait L, Harrist AW, Topham G, Page M. Child gender and weight status moderate the relation of maternal feeding practices to body esteem in 1st grade children. Appetite. 2015 Jun;89:62-9. doi: 10.1016/j.appet.2015.01.017. Epub 2015 Jan 23.
- Harrist AW, Hubbs-Tait L, Topham GL, Shriver LH, Page MC. Emotion regulation is related to children's emotional and external eating. J Dev Behav Pediatr. 2013 Oct;34(8):557-65. doi: 10.1097/DBP.0b013e3182a5095f.
- Shriver LH, Harrist AW, Page M, Hubbs-Tait L, Moulton M, Topham G. Differences in body esteem by weight status, gender, and physical activity among young elementary school-aged children. Body Image. 2013 Jan;10(1):78-84. doi: 10.1016/j.bodyim.2012.10.005. Epub 2012 Nov 24.
- Harrist, A. W., Topham, G. L., Hubbs-Tait, L., Page, M. C., Kennedy, T. S., & Shriver, L. H. (2012). What developmental science can contribute to a multidisciplinary understanding of childhood obesity. Child Development Perspectives, 6, 445-465. doi:10.1111/cdep.12004
- Shriver LH, Harrist AW, Hubbs-Tait L, Topham G, Page M, Barrett A. Weight status, physical activity, and fitness among third-grade rural children. J Sch Health. 2011 Sep;81(9):536-44. doi: 10.1111/j.1746-1561.2011.00624.x.
- Topham GL, Hubbs-Tait L, Rutledge JM, Page MC, Kennedy TS, Shriver LH, Harrist AW. Parenting styles, parental response to child emotion, and family emotional responsiveness are related to child emotional eating. Appetite. 2011 Apr;56(2):261-4. doi: 10.1016/j.appet.2011.01.007. Epub 2011 Jan 11.
- Topham GL, Page MC, Hubbs-Tait L, Rutledge JM, Kennedy TS, Shriver L, Harrist AW. Maternal depression and socio-economic status moderate the parenting style/child obesity association. Public Health Nutr. 2010 Aug;13(8):1237-44. doi: 10.1017/S1368980009992163. Epub 2009 Dec 8.
- Hubbs-Tait L, Kennedy TS, Page MC, Topham GL, Harrist AW. Parental feeding practices predict authoritative, authoritarian, and permissive parenting styles. J Am Diet Assoc. 2008 Jul;108(7):1154-61; discussion 1161-2. doi: 10.1016/j.jada.2008.04.008.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2005年5月1日
一次修了 (実際)
2010年6月1日
研究の完了 (実際)
2010年6月1日
試験登録日
最初に提出
2016年1月7日
QC基準を満たした最初の提出物
2016年1月14日
最初の投稿 (見積もり)
2016年1月20日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年1月20日
QC基準を満たした最後の更新が送信されました
2016年1月14日
最終確認日
2016年1月1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。
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