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A Healthy School Start II
ISRCTN ISRCTN39690370
DOI 10.1186/ISRCTN39690370
ClinicalTrials.gov identifier
EudraCT number
Public title A Healthy School Start II
Scientific title Parental support to promote healthy dietary and physical activity habits in children in pre-school class: a cluster randomised controlled trial
Acronym N/A
Serial number at source N/A
Study hypothesis 1. The children in the intervention group will significantly decrease the mean BMI z-score compared to the control group
2. The children in the intervention group will significantly increase the mean physical activity and reduce the mean time spent sedentary compared to the control group
3. The children in the intervention group will significantly increase the mean intake of healthy indicator foods and decrease the mean intake of unhealthy indicator foods
4. The expected effects of the intervention will be moderated by the socio-economic status of the families
5. The expected effects will be mediated by parental self-efficacy
Lay summary Background and study aims
Chronic diseases constitute the major part of the disease burden worldwide and also in Sweden and early prevention is strongly recommended. There is a lack of universal parental support programmes focusing on a healthy diet and physical activity in children. These factors are important determinants of health and are also strongly influenced by the socioeconomic status of families. Importantly, a broad implementation of the programme may lead to better public health and reduce social inequalities in health.
The aim of the current project is to study the effectiveness of a novel theory-based parental support programme targeting children’s dietary habits, physical activity and body weight in low-income areas.

Who can participate?
All families in these schools with children who are starting school are invited to participate.

What does the study involve?
The Healthy school start programme will take place in approximately 30 school classes in 3 city districts of Stockholm, Sweden, and will be randomly allocated to intervention (programme group) and control groups
The programme consists of three components:
1. Health information material
2. Motivational interviewing (MI) with the parents
3. Teacher-led classroom activities with the children
The control groups carry on as usual. Parents and teachers will be offered the programme after the project has finished.
The Healthy school start programme has been tested once and preliminary results are positive. Based on these findings we have adjusted the programme and are planning to start a second round of evaluation in three city districts in Stockholm with a high proportion of inhabitants with a low socio-economic background.

What are the possible benefits and risks of participating?
Participation may lead to better health for the children.
There are no risks for the participants taking part in the programme.

Where is the study run from?
The programme will be led by researchers from Karolinska Institutet.

When is the study starting and how long is it expected to run for?
The study started in December 2012 and will run till December 2013.

Who is funding the study?
The Public Health Fund, Stockholm County Council is funding the project.

Who is the main contact?
Dr Gisela Nyberg
gisela.nyberg@ki.se
Ethics approval Regional Ethical Review Board in Stockholm, Sweden, 15 June 2012, ref: 2012/877-31/5
Study design Cluster randomised controlled trial
Countries of recruitment Sweden
Disease/condition/study domain Promotion of diet and physical activity and prevention of overweight and obesity in children
Participants - inclusion criteria 1. Schools in three city districts of Stockholm with low socio-economic status
2. All families in these schools with children who are starting school are invited to participate
Participants - exclusion criteria Does not meet inclusion criteria
Anticipated start date 01/12/2012
Anticipated end date 31/12/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants Thirty school classes with 350 families.
Interventions The duration of the intervention is six months. Approximately 30 school classes will be randomised to intervention and control groups. This theory-based intervention (social cognitive theory) is directed at parents with six-year-old children who start school. The intervention consists of three components:
1. Health information material
2. Motivational interviewing (MI) with the parents
3. Teacher-led classroom activities with the children

The control groups carry on as usual. Parents and teachers will be offered the programme after the project has finished.
Intervention fidelity is paid attention to through coding of MI-sessions and recording of all activities. Process evaluation will be studied by performing interviews and focus group with parents, school staff and decision makers.
Primary outcome measure(s) The data will be collected before and after the intervention. Data will also be collected six months after the intervention (follow-up). The long term effects will be studied by collecting data 4 years after the intervention.

1. Body mass index and waist circumference in the children will be measured by the research team.
2. Physical activity of the children (counts per minute, time in moderate to vigorous physical activity and time spent sedentary) will be measured objectively with accelerometers for seven consecutive days.
3. Intake of indicators foods (fruit/vegetables and energy dense products) will be measured with a self-reported questionnaire (EPAQ).

Data from the study will be analysed with both quantitative and qualitative methods (mixed method evaluation).
Secondary outcome measure(s) Parents’ self-efficacy will be assessed by self-reported questionnaire
Sources of funding Stockholm County Council - Public Health Fund (Sweden)
Trial website
Publications
Contact name Dr  Gisela  Nyberg
  Address Karolinska Institutet
Norrbacka plan 3
  City/town Stockholm
  Zip/Postcode 171 76
  Country Sweden
  Email gisela.nyberg@ki.se
Sponsor Stockholm County Council (Sweden)
  Address The Public Health Fund
Box 22550
  City/town Stockholm
  Zip/Postcode 104 22
  Country Sweden
  Email landstinget@sll.se
  Sponsor website: http://www.sll.se/
Date applied 16/11/2012
Last edited 03/01/2013
Date ISRCTN assigned 03/01/2013
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