ISRCTN ISRCTN39690370
DOI https://doi.org/10.1186/ISRCTN39690370
Secondary identifying numbers N/A
Submission date
16/11/2012
Registration date
03/01/2013
Last edited
15/04/2019
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

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

Contact information

Dr Gisela Nyberg
Scientific

Karolinska Institutet
Norrbacka plan 3
Stockholm
171 76
Sweden

Email gisela.nyberg@ki.se

Study information

Study designCluster randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleParental support to promote healthy dietary and physical activity habits in children in pre-school class: a cluster randomised controlled trial
Study objectives1. 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(s)Regional Ethical Review Board in Stockholm, Sweden, 15 June 2012, ref: 2012/877-31/5
Health condition(s) or problem(s) studiedPromotion of diet and physical activity and prevention of overweight and obesity in children
InterventionThe 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 typeOther
Primary outcome measureThe 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 measuresParents' self-efficacy will be assessed by self-reported questionnaire
Overall study start date01/12/2012
Completion date31/12/2013

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participantsThirty school classes with 350 families.
Total final enrolment215
Key inclusion criteria1. 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
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/12/2012
Date of final enrolment31/12/2013

Locations

Countries of recruitment

  • Sweden

Study participating centre

Karolinska Institutet
Stockholm
171 76
Sweden

Sponsor information

Stockholm County Council (Sweden)
Government

The Public Health Fund
Box 22550
Stockholm
104 22
Sweden

Email landstinget@sll.se
Website http://www.sll.se/
ROR logo "ROR" https://ror.org/02zrae794

Funders

Funder type

Government

Stockholm County Council - Public Health Fund (Sweden)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 11/04/2019 15/04/2019 Yes No

Editorial Notes

15/04/2019: Publication reference and total final enrolment number added.