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ObesityBallabeinaNCT00674544

Influence of a Lifestyle Intervention in Preschool Children on Physiological and Psychological Parameters

A study testing Lifestyle intervention in people with Obesity, run by University of Lausanne Hospitals at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Childhood obesity and low fitness tracks into adulthood and carries significant co-morbidities. The investigators test the hypothesis that a multidisciplinary multilevel lifestyle intervention in preschool children in the French and German speaking part of Switzerland during one school-year results in a smaller… Read more about this study

Who is it for?
Ages 3 to 7 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
650 participants
Where
1 siteSwitzerland
Study dates
May 2008to Jun 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 7 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy kindergarten children

Who cannot join

  • Children with severe chronic disease (restricting physical activity)

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Service of Endocrinology, Diabetes and Metabolism; University of Lausanne

    Lausanne, 1010

Other trials in Switzerland

About this study

Official title: Influence of a Lifestyle Intervention in Preschool Children on Physiological and Psychological Parameters (Ballabeina)

Childhood obesity and low fitness tracks into adulthood and carries significant co-morbidities. The investigators test the hypothesis that a multidisciplinary multilevel lifestyle intervention in preschool children in the French and German speaking part of Switzerland during one school-year results in a smaller increase in body mass index (BMI) and a larger increase in aerobic fitness.

Read the detailed description

We will assess the effect of this multidisciplinary intervention in a multicenter cluster randomized controlled trial including a total of 40 kindergarten classes in the French (canton Vaud) and in the German (canton St. Gallen) speaking part of Switzerland. Health promoters, trained in physical education, will receive further postgraduate training (in nutrition, education, psychology) and will then in reward teach several kindergarten teachers hands-on. These trained health promoters will intervene on the level of the kindergarten teacher, the parents, the local community and also on the level of the children following a professional pre-specified curriculum in the kindergarten that focuses primarily on physical activity, healthy nutrition, media use and sleep duration. The curriculum also includes information evenings, workshops and fun weekly homework packages. Special attention will be paid to establish a curriculum that reaches also socio-cultural high risk groups living in Switzerland. Measurements will be performed before and after the intervention.

Conditions
Obesity
Being tested
Lifestyle intervention
Keywords
childhood, children, obesity, physical activity, nutrition, fitness, family
Medical subject headings
Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle interventionBehavioural

    Kindergarten and homebased increases in physical activity, healthy nutrition, sleep duration and decrease in media use: Involvement of parents and siblings

Study groups in NCT00674544
Study groupRoleWhat they receive
Control groupNo interventionNo intervention, regular kindergarten program
Intervention groupExperimentalKindergarten and homebased increases in physical activity, healthy nutrition, sleep duration and decrease in media use: Involvement of parents and siblings
Receives: Behavioral: Lifestyle intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BMI and aerobic fitness

    Measured: 1 schoolyear

Secondary outcomes (7)

  1. total and central body fatness

    Measured: 1 schoolyear

  2. motor abilities

    Measured: 1 schoolyear

  3. physical activity

    Measured: 1 schoolyear

  4. Media use

    Measured: 1 schoolyear

  5. Nutritional behavior and food intake

    Measured: 1 schoolyear

  6. Cognition tests

    Measured: 1 schoolyear

  7. Health-related quality of life, presence of hyperactivity

    Measured: 1 schoolyear

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
650 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00674544
Sponsor's protocol ID
3200BO-116837
Acronym
Ballabeina
Status last verified
Apr 2009
First submitted
6 May 2008
Last updated
28 Jan 2011
Results posted
No
Data monitoring committee
No

Publications

  • Puder JJ, Marques-Vidal P, Schindler C, Zahner L, Niederer I, Burgi F, Ebenegger V, Nydegger A, Kriemler S. Effect of multidimensional lifestyle intervention on fitness and adiposity in predominantly migrant preschool children (Ballabeina): cluster randomised controlled trial. BMJ. 2011 Oct 13;343:d6195. doi: 10.1136/bmj.d6195.

    PubMed 21998346

  • Niederer I, Kriemler S, Gut J, Hartmann T, Schindler C, Barral J, Puder JJ. Relationship of aerobic fitness and motor skills with memory and attention in preschoolers (Ballabeina): a cross-sectional and longitudinal study. BMC Pediatr. 2011 May 11;11:34. doi: 10.1186/1471-2431-11-34.

    PubMed 21569343

  • Burgi F, Meyer U, Granacher U, Schindler C, Marques-Vidal P, Kriemler S, Puder JJ. Relationship of physical activity with motor skills, aerobic fitness and body fat in preschool children: a cross-sectional and longitudinal study (Ballabeina). Int J Obes (Lond). 2011 Jul;35(7):937-44. doi: 10.1038/ijo.2011.54. Epub 2011 Mar 29.

    PubMed 21448128

  • Burgi F, Meyer U, Niederer I, Ebenegger V, Marques-Vidal P, Granacher U, Kriemler S, Puder JJ. Socio-cultural determinants of adiposity and physical activity in preschool children: a cross-sectional study. BMC Public Health. 2010 Nov 26;10:733. doi: 10.1186/1471-2458-10-733.

    PubMed 21110865

  • Niederer I, Kriemler S, Zahner L, Burgi F, Ebenegger V, Hartmann T, Meyer U, Schindler C, Nydegger A, Marques-Vidal P, Puder JJ. Influence of a lifestyle intervention in preschool children on physiological and psychological parameters (Ballabeina): study design of a cluster randomized controlled trial. BMC Public Health. 2009 Mar 31;9:94. doi: 10.1186/1471-2458-9-94.

    PubMed 19335890

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle intervention in people with Obesity, run by University of Lausanne Hospitals at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BMI and aerobic fitness (time frame: 1 schoolyear). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00674544, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2011.

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