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CompletedNCT01070251Updated Aug 1, 2012

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

An interventional study of Participatory parent-focused intervention and State-sponsored PA program in Obesity, sponsored by Heidelberg University. Completed at 2 sites in Germany. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2012-08-01.

Sponsored by Heidelberg University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
826
Allocation
Randomized
Ages
3 Years to 6 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Obesity

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03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 826 is above the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Heidelberg University is the lead sponsor of 287 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Age under 3 years or above 6 years
  • Serious atopic dermatitis
  • Genetic conditions
  • Metabolic diseases
  • Acute infectious diseases
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
826 participants (actual)

Study arms

  • Active comparator
    Existing state-sponsored PA program

    standard children-focused gym lessons approach

    Behavioral: State-sponsored PA program

  • Active comparator
    Participatory intervention plus state-sponsored PA program

    Participatory parent-focused intervention over nine months in addition to state-sponsored PA program

    Behavioral: Participatory parent-focused intervention · Behavioral: State-sponsored PA program

Interventions

  • BehavioralParticipatory parent-focused intervention

    Parent workshops and internet-based support to establish healthy physical activity routines, added to existing state-sponsored PA program

    Also known as: "Ene mene fit - Eltern machen mit!"

  • BehavioralState-sponsored PA program

    Preschool children receive twice a week 60 minutes of physical activity lessons over 6 months by an external gym trainer

    Also known as: Standard physical activity lessons

06

What researchers measure

Primary outcomes

  1. Change in physical activity as measured by accelerometry and heart rate

    before intervention (0 months), 6 and 12 months later

    Time frame: 0,6 and 12 months

Secondary outcomes

  1. 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.

    before intervention (0 months), 6 and 12 months later

    Time frame: 0, 6 and 12 months

Other outcomes

  1. Change in quality of life and subjective wellbeing

    before intervention (0 months), 6 and 12 months later

    Time frame: 0, 6 and 12 months

07

Study locations

2 sites
  • Mannheim Institute of Public Health, University of Heidelberg
    Mannheim, Baden-Wurttemberg 68167, Germany
  • Mannheim Institute of Public Health
    Mannheim, Baden-Wurttemberg 68167, Germany
08

References and documents

Publications

  • 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. PubMed 17028105 ↗
  • 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. PubMed 17899632 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2008, a primary completion of Sep 2010 and a completion of Apr 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 16, 2010
First posted
Feb 17, 2010
Start
Sep 2008
Primary completionActual
Sep 2010
CompletionActual
Apr 2011
Last update
Aug 1, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 1, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01070251
Responsible party
Joachim E. Fischer (Professor >Dr. med. MSc, Heidelberg University) — Principal investigator
First posted
Feb 17, 2010
Start date
Sep 2008
Primary completion
Sep 2010
Completion
Apr 2011
Last update
Aug 1, 2012

Study contacts

Joachim E Fischer, Prof MD MSc
study director · Mannheim Insitute of Public Health, Mannheim Medical Faculty, Heidelberg University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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