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Effects of a Multimodal Preference-based Parental Intervention on Preschoolers' Physical Activity Behaviour - a Cluster-randomized Trial

31. juli 2012 opdateret af: Joachim E. Fischer, Heidelberg University
This study investigates whether a preschool-based physical activity intervention involving parents as active agents of behavioral change affects objectively measured physical activity in preschool children.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

In the last 25 years, obesity in children has increased dramatically in Germany (Lampert et al. 2007, Stolzenberg et al., 2007) and other western societies. Lack of physical activity (PA) is one important factor contributing to obesity development. However, healthy behaviors are established early in life (adiposity rebound: Reilly 2008), which underlines the importance of early interventions. Preschools therefore might be an ideal setting for interventions to promote physical activity. While previous preschool interventions were directly aimed at the children's physical activity behaviors (e.g. promoting activity by sports lessons), parents as influential caregivers were mainly involved in educational ways and by information (e.g. newsletters, physical activity homework).

The current intervention takes a participatory approach to involve parents as active agents of behavioral change. The study aim is to evaluate the effects of the participatory preference-based parental intervention on preschoolers' objectively measured physical activity behaviour and Body Mass Index (BMI). The intervention can easily be added as a parent module to existing children-focused physical activity programmes.

In several workshops, parents are presented a set of possible project ideas for improving everyday physical activity in the preschools. After forming teams, they either select project ideas from the preexisting menu or develop ideas de novo and then implement them into the local preschool environment.

The intervention is implemented in the frame of an existing state-sponsored physical activity (PA) program offering twice weekly sports lessons by external gym trainers to preschoolers over a period of 6 months. Preschools in the control arm get the state-sponsored PA program only. Preschools in the intervention arm get the participatory parent-focused PA intervention in addition to the existing state-sponsored PA program.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

826

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
    • Baden-Württemberg
      • Mannheim, Baden-Württemberg, Tyskland, 68167
        • Mannheim Institute of Public Health, University of Heidelberg
      • Mannheim, Baden-Württemberg, Tyskland, 68167
        • Mannheim Institute of Public Health

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

3 år til 6 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Healthy children
  • Participation in the standard physical activity lesson twice weekly

Exclusion Criteria:

  • Age under 3 years or above 6 years
  • Serious atopic dermatitis
  • Genetic conditions
  • Metabolic diseases
  • Acute infectious diseases

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Existing state-sponsored PA program
standard children-focused gym lessons approach
Adfærdsmæssigt: State-sponsored PA program
Preschool children receive twice a week 60 minutes of physical activity lessons over 6 months by an external gym trainer
Andre navne:
  • Standard physical activity lessons
Aktiv komparator: Participatory intervention plus state-sponsored PA program
Participatory parent-focused intervention over nine months in addition to state-sponsored PA program
Adfærdsmæssigt: State-sponsored PA program
Preschool children receive twice a week 60 minutes of physical activity lessons over 6 months by an external gym trainer
Andre navne:
  • Standard physical activity lessons
Adfærdsmæssigt: Participatory parent-focused intervention
Parent workshops and internet-based support to establish healthy physical activity routines, added to existing state-sponsored PA program
Andre navne:
  • "Ene mene fit - Eltern machen mit!"

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in physical activity as measured by accelerometry and heart rate
Tidsramme: 0,6 and 12 months
before intervention (0 months), 6 and 12 months later
0,6 and 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Body Mass Index, percent fat mass (based on skin folds), waist-to-height ratio and waist circumference Change in blood pressure, sympathetic/parasympathetic tone. Sleep quantity by accelerometry.
Tidsramme: 0, 6 and 12 months
before intervention (0 months), 6 and 12 months later
0, 6 and 12 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in quality of life and subjective wellbeing
Tidsramme: 0, 6 and 12 months
before intervention (0 months), 6 and 12 months later
0, 6 and 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Heidelberg University

Efterforskere

  • Studieleder: Joachim E Fischer, Prof MD MSc, Mannheim Insitute of Public Health, Mannheim Medical Faculty, Heidelberg University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2008

Primær færdiggørelse (Faktiske)

1. september 2010

Studieafslutning (Faktiske)

1. april 2011

Datoer for studieregistrering

Først indsendt

16. februar 2010

Først indsendt, der opfyldte QC-kriterier

16. februar 2010

Først opslået (Skøn)

17. februar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. august 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. juli 2012

Sidst verificeret

1. juli 2012

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • CRTLasti_PA_kiga

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med State-sponsored PA program

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Betingelser

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