A Healthy School Start

ISRCTN	ISRCTN32750699
DOI	https://doi.org/10.1186/ISRCTN32750699
Protocol serial number	N/A
Sponsor	Health Care Board and Management (Hälso och sjukvårdens förvaltning) (Sweden)
Funder	Stockholm County Council (Folkhälsoanslaget) (Sweden) - Sweden and Signhild Engkvist Foundation

Submission date: 13/12/2010
Registration date: 07/02/2011
Last edited: 16/02/2015

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

Dr Gisela Nyberg
Scientific

Karolinska Institutet
Division of Intervention and Implementation Research
Department of Public Health Sciences
Box 17070
Stockholm
104 62
Sweden

Email	gisela.nyberg@ki.se

Study information

Primary study design	Interventional
Study design	Cluster randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Parental support to promote healthy dietary and physical activity habits in children: a randomised controlled trial
Study objectives	The overall aim is to develop and evaluate a method to promote healthy dietary and physical activity habits in six-year-old children.
Ethics approval(s)	Regional Ethical Review Board in Stockholm approved on the 23rd June 2010 (ref: 2010/934-31/1)
Health condition(s) or problem(s) studied	Overweight, obesity
Intervention	The duration of the intervention is six months. Fourteen classes are randomised to intervention (n = 7) and control (n = 7) groups. This theory-based intervention (social cognitive theory) is directed at parents with six-year-old children who start school. The intervention consists of two components: 1. When parents in the intervention group have their regular meeting with the health care staff at school they are offered a motivational interview where they discuss issues related to diet, physical activity and sleep. A second motivational interview is offered three months later. 2. Children in class are exposed to ten teacher-led sessions aiming to "take home" messages to enforce parents. The control groups carry on as usual. Parents and teachers will be offered the intervention components after the project has finished.
Intervention type	Other
Primary outcome measure(s)	1. Physical activity in the children (counts per minute, intensity and time spent sedentary) will be measured objectively with accelerometers for seven consecutive days 2. Intake of food indicators (fruit/vegetables and energy dense products) will be measured with a self-reported questionnaire 3. Parents' self-efficacy will be measured by self-reported questionnaire 4. Experiences from the study will be collected by interviewing parents and teachers in focus groups The data will be collected before and after the intervention. Data will also be collected six months after the intervention (follow-up). Data from the study will be analysed with parametric and non-parametric tests.
Key secondary outcome measure(s)	Body mass index and waist circumference in the children will be measured by the research team. The data will be collected before and after the intervention. Data will also be collected six months after the intervention (follow-up). Data from the study will be analysed with parametric and non-parametric tests.
Completion date	30/06/2012

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	200
Key inclusion criteria	Schools with families living in varied types of housing (blocks of flats, terraced houses and detached houses), where about 30% of families live in blocks of flats, are invited to participate in the study. Families in these schools with six-year-old children who are starting school are invited to participate in the project.
Key exclusion criteria	1. Schools with a high proportion of families with high socio-economic position 2. Parents/guardians that have difficulties with the Swedish language
Date of first enrolment	01/01/2010
Date of final enrolment	30/06/2012

Locations

Countries of recruitment

Sweden

Study participating centre

Karolinska Institutet

Stockholm
104 62
Sweden

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	Date added	Peer reviewed?	Patient-facing?
Results article	results	13/02/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes