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.
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)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2006to Jul 2007
- Phase
- Phase 1/2
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.
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.
Bodyweight after 3 and 6 months
Bodycomposition after 3 and 6 months
Bodyfat distribution after 3 and 6 months
Secondary outcomes (3)
Eating behavior after 3 and 6 months
Physical activity after 3 and 6 months
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.
- First posted6 Jul 2006 (estimated)
- Study startJul 2006
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- University College of Antwerp
- Sponsor type
- University, hospital or other
- Investigators
- Steven Truijen, PhD, Study chair, University College of AntwerpLuc Van Gaal, MD, PhD, Principal investigator, Universiteit AntwerpenDirk Vissers, Study director, University College of Antwerp
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 15096099Hulens 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 11319638Must 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 10340798Goran 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 11157310Van 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 9130034Gortmaker 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 10201726Muller 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