'Be active, eat right' - Lifestyle, growth and health of children aged 4 to 7

ISRCTN	ISRCTN04965410
DOI	https://doi.org/10.1186/ISRCTN04965410
Protocol serial number	NTR921
Sponsor	Erasmus Medical Centre (Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Submission date: 11/04/2007
Registration date: 11/04/2007
Last edited: 30/09/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms L Veldhuis
Scientific

Erasmus Medical Centre, Room AE-131
Universitair Medisch Centrum Rotterdam
Afdeling Maatschappelijke Gezondheidszorg
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Phone	+31 (0)10 703 8453
Email	l.veldhuis@erasmusmc.nl

Study information

Primary study design	Interventional
Study design	Randomised active-controlled parallel-group multicentre trial
Secondary study design	Randomised controlled trial
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
Study objectives	Current hypothesis as of 24/07/2008: 1. 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) 2. The prevention protocol applied to parents and their 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 body mass index (BMI) and waist circumference at age 7 compared to overweight children in the control group who receive usual care Previous hypothesis: It is hypothesised that the results of the evaluation of the overweight prevention-protocol and the overweight detection-protocol will be that they are effective and efficient protocols for overall use in the Youth-Health-Care (YHC). On 24/07/2008 the following changes were made to this trial record: 1. The public trial title was changed from "'Be active, eat well', a healthy lifestyle for children at the age of five and six years: evaluation of the Dutch preventive Youth Health Care (YHC) overweight prevention-protocol and overweight detection-protocol among children at the age of five and six years in a cluster randomised trial". 2. The scientific trial title was added. 3. The anticipated trial start date has been updated from 01/09/2007.
Ethics approval(s)	Medical Ethics Research Committee of Erasmus MC, University Medical Centre Rotterdam, 17/09/2007, ref: MEC-2007-163
Health condition(s) or problem(s) studied	Youth Health Care and prevention of obesity in children
Intervention	Current interventions as of 24/07/2008: The YHC teams in both the intervention and control groups will apply the detection protocol and label children as "normal weight", "overweight" or "obese". The detection protocol entails measuring weight and height of the children, calculating their BMI and comparing it to international sex and age specific BMI cut-off points for overweight and obesity. 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-programme. The YHC professionals will assess whether the parents are motivated to participate in counselling to promote overweight preventing behaviours, and will make use of a motivational interview approach. The three additional structured lifestyle counselling visits are offered to parents in intervals of one, three and six months. During the visits, energy intake and expenditure diaries are used, which will be completed by the parents. The YHC professional and the parents together will draw up a family-oriented action plan aiming at promotion of physical activity and outdoor playing time, having breakfast daily, less sweet drinks and limitation of television and/or computer time. The YHC teams in the control group will offer the parents of children with overweight usual care as offered by the YHC teams. Previous interventions: All YHC-teams will carry out the overweight detection-protocol and applying labels for 'normal weight', 'overweight, but no obesity' and 'overweight'. The YHC-teams in the intervention group will then offer the parents and children with 'overweight, but no obesity' the prevention-protocol, which includes a structured three-YHC-visits-program. The YHC-teams in the control group will offer the parents and children with 'overweight, but no obesity' the 'usual care', which includes the care the YHC-teams offer before implementing the prevention-protocol. Contact for scientific queries: Dr H Raat Erasmus Medical Centre Department of Public Health P.O. Box 2040 Rotterdam 3000 CA Netherlands Tel: +31 (0)10 70 44095/ +31 (0)10 70 38453 Fax: +31 (0)10 703 8474 h.raat@erasmusmc.nl
Intervention type	Other
Primary outcome measure(s)	Current primary outcome measures as of 28/07/2008: Evaluation of the prevention protocol: 1. Body Mass Index (BMI), measured at baseline (age 5) and 24 months (age 7) 2. Waist circumference, measured at baseline (age 5) and 24 months (age 7) Evaluation of the detection protocol: 1. Proportion of children labelled as "normal weight", "overweight" and "obesity" according to the detection protocol, measured at baseline (age 5) and 24 months (age 7) Timepoints of measurement: 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) Previous primary outcome measures: Evaluation Prevention-protocol: Change in body fat and relative change in Body Mass Index (BMI) two years after the 'PGO'* among children at the age of five or six years, in children with 'overweight but no obesity' in the Intervention group relative to the Control group. Time-point measurements: PGO: September 2007 -June 2008 Repetition of measurements: September 2009 - June 2010 Evaluation Detection-protocol: Predictive value of the labels 'normal weight', 'overweight but not obesity', and 'obesity' at the 'PGO' among children at the age of five or six years, according to the Detection-protocol for the presence of these labels at the age of about seven years, in the absence of weight-management interventions. Time-point measurements: PGO: September 2007 - June 2008 Repetition of detection: September 2009 - June 2010 *The 'PGO' is a contact moment at the Municipal Health Service (GGD'en) where a specialised physician carries out a preventive health check on all children in the second year of elementary school.
Key secondary outcome measure(s)	Current secondary outcome measures as of 28/07/2008: Evaluation of the prevention protocol: 1. Levels of the four target overweight-reducing and overweight-inducing behaviours, i.e. being physically active, eating breakfast daily, drinking sweet beverages and watching TV or playing on a computer, measured at baseline (age 5), 12 months (age 6) and 24 months (age 7) 2. Health-related quality of life, measured at baseline (age 5), 12 months (age 6) and 24 months (age 7) 3. Attitudes of parents regarding the four target behaviours mentioned above (see 1), measured at baseline (age 5), 12 months (age 6) and 24 months (age 7) 4. Absence or presence of indicators of negative side effects, i.e. worry, stigmatisation, lowered self-esteem and development of relative underweight, measured at baseline (age 5) and 24 months (age 7) Evaluation of the detection protocol: 1. Sensitivity and specificity of the labels "normal weight", "overweight" and "obesity" according to the detection protocol, measured at baseline (age 5) and 24 months (age 7) Timepoints of measurement: 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) Previous secondary outcome measures: 1. Waist circumference Time-point measurements: PGO: September 2007 - June 2008 Repetition of measurements: September 2009 - June 2010 2. Levels of five target overweight reducing and inducing behaviours 3. Health-related quality of life 4. Attitudes of parents regarding the specific health behaviours 5. Absence/presence of indicators of negative side effects (worry, stigmatisation, lowered self-esteem, and development of relative underweight) Time-point measurements: PGO: September 2007 - June 2008 First follow-up measurement: September 2008 - June 2009 Second follow-up measurement: September 2009 - June 2010
Completion date	01/09/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	7200
Key inclusion criteria	Current inclusion criteria as of 24/07/2008: The 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. Previous inclusion criteria: All children in the second year of elementary school who are invited by the municipal health services to visit the YHC-team will be included in the study.
Key exclusion criteria	Current exclusion criteria as of 30/07/2008: For the prevention protocol and the questionnaires used in the study, parents without basic Dutch language skills will be excluded. Previous exclusion criteria: In the study questionnaires and counselling will be used. Therefore it is necessary that parents are able to understand and communicate in Dutch. Furthermore it is possible that in some cases of children and parents who visit the YHC-teams, weight and potential overweight are not high priority factors and other factors are more important to discuss and pay attention to.
Date of first enrolment	18/09/2007
Date of final enrolment	01/09/2010

Locations

Countries of recruitment

Netherlands

Study participating centre

Erasmus Medical Centre, Room AE-131

Rotterdam
3000 CA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	31/05/2013	Yes	No
Results article	results	21/01/2014	Yes	No
Protocol article	protocol	08/06/2009	Yes	No