Condition category
Nutritional, Metabolic, Endocrine
Date applied
13/12/2010
Date assigned
07/02/2011
Last edited
16/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gisela Nyberg

ORCID ID

Contact details

Karolinska Institutet
Division of Intervention and Implementation Research
Department of Public Health Sciences
Box 17070
Stockholm
104 62
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: a randomised controlled trial

Acronym

Study hypothesis

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

Regional Ethical Review Board in Stockholm approved on the 23rd June 2010 (ref: 2010/934-31/1)

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

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/01/2010

Overall trial end date

30/06/2012

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

200 families

Participant 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

Recruitment start date

01/01/2010

Recruitment end date

30/06/2012

Locations

Countries of recruitment

Sweden

Trial participating centre

Karolinska Institutet
Stockholm
104 62
Sweden

Sponsor information

Organisation

Health Care Board and Management (Hälso och sjukvårdens förvaltning) (Sweden)

Sponsor details

Folkhälsoanslaget
Box 6909
Stockholm
102 39
Sweden

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Stockholm County Council (Folkhälsoanslaget) (Sweden) - Sweden and Signhild Engkvist Foundation

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25680096

Publication citations

Additional files

Editorial Notes