Plain English 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 childrens 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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Gisela Nyberg
ORCID ID
Contact details
Karolinska Institutet
Norrbacka plan 3
Stockholm
171 76
Sweden
-
gisela.nyberg@ki.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Parental support to promote healthy dietary and physical activity habits in children in pre-school class: a cluster randomised controlled trial
Acronym
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
Ethics approval
Regional Ethical Review Board in Stockholm, Sweden, 15 June 2012, ref: 2012/877-31/5
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Promotion of diet and physical activity and prevention of overweight and obesity in children
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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 measures
Parents' self-efficacy will be assessed by self-reported questionnaire
Overall trial start date
01/12/2012
Overall trial end date
31/12/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
Thirty school classes with 350 families.
Total final enrolment
215
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/12/2012
Recruitment end date
31/12/2013
Locations
Countries of recruitment
Sweden
Trial participating centre
Karolinska Institutet
Stockholm
171 76
Sweden
Sponsor information
Organisation
Stockholm County Council (Sweden)
Sponsor details
The Public Health Fund
Box 22550
Stockholm
104 22
Sweden
-
landstinget@sll.se
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Stockholm County Council - Public Health Fund (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30975106 [added 15/04/2019]