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Families and Schools for Health (FiSH)

14 gennaio 2016 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

541

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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%.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione fattoriale
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Sperimentale: 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.
Sperimentale: 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
Sperimentale: 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
Nessun intervento: Control (n = 82)
Non-intervention control group

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Body Mass Change from Baseline to End of 1st grade
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Wave 5, Spring Year 4
Height and weight measured at Wave 5 (Spring 4th grade) vs. Baseline at Wave 1, Fall 1st grade
Wave 5, Spring Year 4

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Parent perceived responsibility, weight, child weight, concerns about weight, feeding practices - parent report
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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 emotion management - Parent and child report
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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 emotional and external eating - child self report
Lasso di tempo: 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
Body esteem - child self report
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Investigatore principale: Amanda W Harrist, PhD, Oklahoma State University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2005

Completamento primario (Effettivo)

1 giugno 2010

Completamento dello studio (Effettivo)

1 giugno 2010

Date di iscrizione allo studio

Primo inviato

7 gennaio 2016

Primo inviato che soddisfa i criteri di controllo qualità

14 gennaio 2016

Primo Inserito (Stima)

20 gennaio 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

20 gennaio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 gennaio 2016

Ultimo verificato

1 gennaio 2016

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • NIFA/USDA Agreement No. 05545
  • HR07-044, HR08-043 (Altro numero di sovvenzione/finanziamento: Oklahoma Health Research Program)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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