- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01070251
Effects of a Multimodal Preference-based Parental Intervention on Preschoolers' Physical Activity Behaviour - a Cluster-randomized Trial
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Existing state-sponsored PA program
standard children-focused gym lessons approach
|
Preschool children receive twice a week 60 minutes of physical activity lessons over 6 months by an external gym trainer
Andra namn:
|
|
Aktiv komparator: Participatory intervention plus state-sponsored PA program
Participatory parent-focused intervention over nine months in addition to state-sponsored PA program
|
Preschool children receive twice a week 60 minutes of physical activity lessons over 6 months by an external gym trainer
Andra namn:
Parent workshops and internet-based support to establish healthy physical activity routines, added to existing state-sponsored PA program
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in physical activity as measured by accelerometry and heart rate
Tidsram: 0,6 and 12 months
|
before intervention (0 months), 6 and 12 months later
|
0,6 and 12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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.
Tidsram: 0, 6 and 12 months
|
before intervention (0 months), 6 and 12 months later
|
0, 6 and 12 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in quality of life and subjective wellbeing
Tidsram: 0, 6 and 12 months
|
before intervention (0 months), 6 and 12 months later
|
0, 6 and 12 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Joachim E Fischer, Prof MD MSc, Mannheim Insitute of Public Health, Mannheim Medical Faculty, Heidelberg University
Publikationer och användbara länkar
Allmänna publikationer
- Reilly JJ, Kelly L, Montgomery C, Williamson A, Fisher A, McColl JH, Lo Conte R, Paton JY, Grant S. Physical activity to prevent obesity in young children: cluster randomised controlled trial. BMJ. 2006 Nov 18;333(7577):1041. doi: 10.1136/bmj.38979.623773.55. Epub 2006 Oct 6.
- Taylor RW, Mcauley KA, Williams SM, Barbezat W, Nielsen G, Mann JI. Reducing weight gain in children through enhancing physical activity and nutrition: the APPLE project. Int J Pediatr Obes. 2006;1(3):146-52. doi: 10.1080/17477160600881247.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- CRTLasti_PA_kiga
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .