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‘Be active, eat right’, Lifestyle, growth and health of children aged 4 to 7


- candidate number2499
- NTR NumberNTR921
- ISRCTNISRCTN04965410
- Date ISRCTN created11-apr-2007
- date ISRCTN requested24-mrt-2007
- Date Registered NTR26-feb-2007
- Secondary IDs505011098355 ZonMw project number
- Public Title‘Be active, eat right’, Lifestyle, growth and health of children aged 4 to 7
- Scientific Title‘Be active, eat right’, Lifestyle, growth and health of children aged 4 to 7, Evaluation of an overweight detection protocol (‘Signaleringsprotocol Overgewicht’) and an overweight prevention protocol (‘Overbruggingsplan Overgewicht’) in Dutch Youth Health Care among children aged 4 to 7 and their parents in a cluster randomised trial.
- ACRONYMN/A
- hypothesis- The detection protocol applied at age 5 (second year of elementary school) predicts the presence of overweight at age 7 (fourth year of elementary school).
- The prevention protocol applied to parents of overweight children aged 5 (second year of elementary school) results in a better lifestyle at age 6 (third year of elementary school) and age 7 (fourth year of elementary school) and results in a relatively lower BMI and waist circumference at age 7 compared to children in the control group who receive usual care
- Healt Condition(s) or Problem(s) studiedOverweight, Obesity, Prevention, Efficacy, Youth-Health-Care, Children
- Inclusion criteriaThe study population consists of all children and their parents who will be invited for a preventive health check by the 44 participating YHC-teams of the 9 participating Municipal Health Services in the Netherlands, during the second year of elementary school during school year 2007/2008.
- Exclusion criteriaFor the prevention protocol and the questionnaires used in the study the parents should have basic Dutch language skills.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 18-sep-2007
- planned closingdate1-sep-2010
- Target number of participants7200
- InterventionsThe YHC-teams in both the intervention group and control group will apply the detection protocol and label children as normal weight, overweight or obese. The YHC-teams in the intervention group will then offer the parents of children with overweight the prevention protocol, which includes a structured three-YHC-visits-program. The YHC-teams in the control group will offer the parents of children with overweight usual care as offered by the YHC-teams.
- Primary outcomeRegarding the evaluation of the prevention protocol:
1. Body Mass Index (BMI)
2. Waist circumference
Regarding the evaluation of the detection protocol:
1. Labels normal weight, overweight and obesity according to the detection protocol
- Secondary outcomeRegarding the evaluation of the prevention protocol:
1. Levels of the four target overweight reducing and inducing behaviours, i.e. being physically active, eating breakfast daily, drinking sweet beverages and watching TV or playing on a computer
2. Health-related quality of life
3. Attitudes of parents regarding the four target behaviours mentioned by 1.
4. Absence or presence of indicators of negative side effects, i.e. worry, stigmatisation, lowered self-esteem and development of relative underweight.
Regarding the evaluation of the detection protocol:
1. Sensitivity and specificity of the labels normal weight, overweight and obesity according to the detection protocol.
- TimepointsTime points measurements:
- Age 5 (second year of elementary school): preventive health check (September 2007 – June 2008)
- Age 6 (third year of elementary school): first follow-up measurement (September 2008 – June 2009)
- Age 7 (fourth year of elementary school): second follow-up measurement (September 2009 – June 2010)
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. L. Veldhuis
- CONTACT for SCIENTIFIC QUERIESDr. Hein Raat
- Sponsor/Initiator Erasmus Medical Center, Department of Public Health
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryBackground.
The prevalence of overweight and obesity in children has at least doubled in the past 25 years. In Dutch Youth Health Care there was an urgent need for standardized protocols for the detection and prevention of overweight and obesity in children. In 2004 and 2005 a detection protocol (‘Signaleringsprotocol Overgewicht’) and a prevention protocol (‘Overbruggingsplan’) were developed. This study aims to evaluate the predictive value of the detection protocol and to evaluate the effects of the prevention protocol.

Objective.
In this study we will evaluate the effects of the prevention protocol in children with overweight in terms of measures of body fatness (BMI and waist circumference) and in terms of the four target behaviours, which reduce and induce overweight (i.e. being physically active, eating breakfast daily, drinking sweetened beverages and watching TV or playing on a computer). Secondarily, within the control group we will evaluate the predictive value of the detection protocol by comparing the labels normal weight, overweight and obesity according to the detection protocol at the age of 5, with these labels at the age of 7. In addition we will conduct a process evaluation and a cost-effectiveness analysis will be performed.

Methods/design.
The design of the study is a cluster-randomised trial with the YHC-teams as the unit of randomisation and a follow-up period of 2 years. Prior to the preventive health check all parents will receive the informed consent form for participating in the study and a two-paged questionnaire to assess some basic socio-demographic variables and health behaviours. During the preventive health check the YHC-teams in both the intervention group and control group will apply the detection protocol (which includes measuring the primary outcome measurements BMI and waist circumference) and will label children as normal weight, overweight or obese. The YHC-teams in the intervention group will than offer the parents of children with overweight the prevention protocol, which includes a structured three-YHC-visits-program. The YHC-teams in the control group will offer the parents of children with overweight usual care as offered by the YHC-teams before implementing the prevention protocol. Questionnaires to assess the secondary outcome measurements (the levels of the four target behaviours, health-related quality of life, the attitudes of parents regarding the four target behaviours and the absence or presence of indicators of negative side effects) will take place at baseline and after 12 and 24 months of follow-up. After 24 months of follow-up measures of BMI, waist circumference and labelling of the participating children with normal weight, overweight or obesity will be repeated.
- Main changes (audit trail)
- RECORD26-feb-2007 - 22-jul-2008


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