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OverweightPhase 1/2NCT00349232

Lifestyle Intervention in Obese Children Attending Special Primary Education.

A Phase 1/2 study testing lifestyle intervention (diet and physical activity) in people with Overweight and Obesity, run by University College of Antwerp at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to assess the prevalence of overweight and obesity in children attending special primary education and to evaluate the effects of a multidisciplinary school-based lifestyle intervention. Read more about this study

Who is it for?
Ages 6 to 14 yearsHealthy volunteers can take part
Conditions the study is for
Overweight, Obesity
What is being tested?
lifestyle intervention (diet and physical activity)
How many people
100 participants
Where
1 siteBelgium
Study dates
Jul 2006to Jul 2007
Phase
Phase 1/2
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 6 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • children attending special and regular primary education

Who cannot join

  • endocrine conditions affecting bodyweight (e.g. thyroid disease, diabetes)
  • mental or physical disabilities that make it impossible to participate in sports activities

Trial locations and contacts

1 site in 1 country.

Dirk Vissers contact

00 32 3 6418265

d.vissers@ha.be

Belgium1 site

  • MPI Zonnebos

    Antwerp, Antwerp, 2970

Other trials in Belgium

About this study

Official title: Prevalence of Overweight and Obesity in Children Attending Special Primary Education and the Effect of a Lifestyle Intervention.

The purpose of this study is to assess the prevalence of overweight and obesity in children attending special primary education and to evaluate the effects of a multidisciplinary school-based lifestyle intervention.

Read the detailed description

Lifestyle changes related to high-fat diets and low levels of physical activity have resulted in a rising prevalence of overweight and obesity in children and adolescents. Ten per cent of the world's school-aged children are estimated to have excess body fat. Overweight and obesity during childhood and adolescence tend to continue into adulthood, increasing the likelihood of a range of impaired health conditions including cardiovascular diseases, diabetes and some cancers. School-based interventions have been proposed to prevent or treat obesity and have been described as a promising approach to reducing obesity among youth. First the extent and the characteristics of the problem have to be assessed for different types of education.

Comparison(s): the prevalence of overweight and obesity in special primary education will be compared to the prevalence in regular primary education. In special primary education, obese and overweight children will be randomised into a experimentel group (6 months of lifestyle intervention including diet and physical activity) and a control group (6 months normal treatment, if any, e.g. exercises for motor skills).

Conditions
Overweight, Obesity
Being tested
lifestyle intervention (diet and physical activity)
Keywords
childhood obesity, lifestyle intervention, school health program, special primary education
Medical subject headings
Overweight, Obesity, Pediatric Obesity

What participants receive

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

  • lifestyle intervention (diet and physical activity)Behavioural

What is being measured

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

  1. Bodyweight after 3 and 6 months

  2. Bodycomposition after 3 and 6 months

  3. Bodyfat distribution after 3 and 6 months

Secondary outcomes (3)

  1. Eating behavior after 3 and 6 months

  2. Physical activity after 3 and 6 months

  3. Quality of life after 3 and 6 months

Timeline

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

  1. First posted6 Jul 2006 (estimated)
  2. Study startJul 2006
  3. Study completionJul 2007

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
100 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00349232
Sponsor's protocol ID
HA-KINE-2006-001
Status last verified
Jul 2006
First submitted
4 Jul 2006
Last updated
10 Jul 2006
Results posted
No

Publications

  • Lobstein T, Baur L, Uauy R; IASO International Obesity TaskForce. Obesity in children and young people: a crisis in public health. Obes Rev. 2004 May;5 Suppl 1:4-104. doi: 10.1111/j.1467-789X.2004.00133.x. No abstract available.

    PubMed 15096099

  • Hulens M, Beunen G, Claessens AL, Lefevre J, Thomis M, Philippaerts R, Borms J, Vrijens J, Lysens R, Vansant G. Trends in BMI among Belgian children, adolescents and adults from 1969 to 1996. Int J Obes Relat Metab Disord. 2001 Mar;25(3):395-9. doi: 10.1038/sj.ijo.0801513.

    PubMed 11319638

  • Must A, Strauss RS. Risks and consequences of childhood and adolescent obesity. Int J Obes Relat Metab Disord. 1999 Mar;23 Suppl 2:S2-11. doi: 10.1038/sj.ijo.0800852.

    PubMed 10340798

  • Goran MI. Metabolic precursors and effects of obesity in children: a decade of progress, 1990-1999. Am J Clin Nutr. 2001 Feb;73(2):158-71. doi: 10.1093/ajcn/73.2.158.

    PubMed 11157310

  • Van Gaal LF, Wauters MA, De Leeuw IH. The beneficial effects of modest weight loss on cardiovascular risk factors. Int J Obes Relat Metab Disord. 1997 Mar;21 Suppl 1:S5-9.

    PubMed 9130034

  • Gortmaker SL, Peterson K, Wiecha J, Sobol AM, Dixit S, Fox MK, Laird N. Reducing obesity via a school-based interdisciplinary intervention among youth: Planet Health. Arch Pediatr Adolesc Med. 1999 Apr;153(4):409-18. doi: 10.1001/archpedi.153.4.409.

    PubMed 10201726

  • Muller MJ, Danielzik S, Pust S. School- and family-based interventions to prevent overweight in children. Proc Nutr Soc. 2005 May;64(2):249-54. doi: 10.1079/pns2005424.

    PubMed 15960869

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing lifestyle intervention (diet and physical activity) in people with Overweight and Obesity, run by University College of Antwerp at 1 site in Belgium.

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 2 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: status not confirmed, as of the sponsor's last update on 10 Jul 2006. 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 Belgium. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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

Contact Dirk Vissers (00 32 3 6418265, d.vissers@ha.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bodyweight after 3 and 6 months. The study lists 3 primary outcomes in all. 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 NCT00349232, which also lists 7 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 10 Jul 2006.

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