A Healthy School Start
| ISRCTN | ISRCTN32750699 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32750699 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Karolinska Institutet
Division of Intervention and Implementation Research
Department of Public Health Sciences
Box 17070
Stockholm
104 62
Sweden
| gisela.nyberg@ki.se |
Study information
| Study design | Cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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. |
| Secondary outcome measures | 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. |
| Overall study start date | 01/01/2010 |
| Completion date | 30/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 200 families |
| 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
104 62
Sweden
Sponsor information
Health Care Board and Management (Hälso och sjukvårdens förvaltning) (Sweden)
Government
Government
Folkhälsoanslaget
Box 6909
Stockholm
102 39
Sweden
"ROR" |
https://ror.org/04d5f4w73 |
|---|
Funders
Funder type
Government
Stockholm County Council (Folkhälsoanslaget) (Sweden) - Sweden and Signhild Engkvist Foundation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
