|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
5 May 2019 |
|
Main ID: |
ISRCTN39690370 |
|
Date of registration:
|
03/01/2013 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
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 |
|
Date of first enrolment:
|
01/12/2012 |
|
Target sample size:
|
350 |
|
Recruitment status: |
Completed |
|
URL:
|
http://isrctn.com/ISRCTN39690370 |
|
Study type:
|
Interventional |
|
Study design:
|
Cluster randomised controlled trial (Quality of life)
|
|
Phase:
|
Not Applicable
|
|
|
Countries of recruitment
|
|
Sweden
| | | | | | | |
|
Contacts
|
|
Name:
|
Gisela
Nyberg |
|
Address:
|
Karolinska Institutet
Norrbacka plan 3
171 76
Stockholm
Sweden |
|
Telephone:
|
- |
|
Email:
|
gisela.nyberg@ki.se |
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
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
Exclusion criteria: Does not meet inclusion criteria
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Promotion of diet and physical activity and prevention of overweight and obesity in children
Nutritional, Metabolic, Endocrine
Obesity
|
|
Intervention(s)
|
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(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(s)
|
|
Parents' self-efficacy will be assessed by self-reported questionnaire
|
|
Source(s) of Monetary Support
|
|
Stockholm County Council - Public Health Fund (Sweden)
|
|
Ethics review
|
Status:
Approval date:
Contact:
Regional Ethical Review Board in Stockholm, Sweden, 15 June 2012, ref: 2012/877-31/5
|
|
Results
|
|
Results available:
|
Yes |
|
Date Posted:
|
|
|
Date Completed:
|
31/12/2013 |
|
URL:
|
|
|
|