Condition category
Not Applicable
Date applied
26/08/2019
Date assigned
23/09/2019
Last edited
23/09/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
There are large social inequalities, seen already from an early age, in dietary habits, physical activity and prevalence of obesity to the disadvantage of children from families with low socioeconomic status. Therefore, it is of importance to promote physical activity and a healthy lifestyle early in life. Effective strategies are needed in order to reach those at highest risk of diseases. Interventions have shown to be more successful when parents are involved. The aim was to study if a preventive lifestyle programme “A Healthy Generation” leads to a physically active and healthy lifestyle, a decreased risk of cardiovascular disease, improved quality of life for children and their families from disadvantaged areas.

Who can participate?
In this controlled pilot study, all children in grade two (8-9 years), their siblings and their parents living in a socioeconomically disadvantaged municipality outside Stockholm were invited through four schools. Families from two schools that had accepted an invitation to take part in the programme (intervention group) and families from two similar schools in the same area that had not yet implemented the programme (control group) were invited to participate in the study.

What does the study involve?
The programme consisted of four intervention components, 1) activity sessions, 2) healthy meals, 3) health information and 4) parental support groups. Families with children in grade two (6-7 years) were offered different physical activities at no cost during nine months in collaboration with local organisations and schools. The activity sessions were followed by healthy meals and during the meal sessions the health coordinator discussed different health themes. The parents were also invited to parental support group sessions which were led by qualified staff and organised by the municipality.

What are the possible benefits and risks of participating?
Participation may lead to better health for the families. The risks for the participants taking part in the intervention are minimal.

Where is the study run from?
The evaluation will be led by researchers from the Department of Public Health Sciences at Karolinska Institutet, Sweden.

When is the study starting and how long is it expected to run for?
March 2016 to December 2018

Who is funding the study
The Swedish Heart-Lung Foundation and Skandia are funding the project

Who is the main contact?
Dr Gisela Nyberg
gisela.nyberg@ki.se

Trial website

http://www.enfriskgeneration.se/a-healthy-generation/

Contact information

Type

Scientific

Primary contact

Dr Gisela Nyberg

ORCID ID

http://orcid.org/0000-0003-0004-8533

Contact details

Karolinska Insitutet
Solnavägen 1E
Stockholm
113 65
Sweden
+46766009179
Gisela.Nyberg@ki.se

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

A Healthy Generation - a programme to promote physical activity and a healthy lifestyle in children and their families in socioeconomically disadvantaged areas

Acronym

Study hypothesis

The programme will increase physical activity, decrease cardiovascular risk, improve psychosocial health, well-being and quality of life and promote a healthy lifestyle in children and their families in socioeconomically disadvantaged areas

Ethics approval

Approved 30/03/2016, the Regional Ethical Board in Stockholm (Etikprövningsmyndigheten,
Tomtebodavägen 18A, 17165 Solna, Sverige; registrator@etikprovning.se; +46-(0)10-475 08 00) ref: 2016/447-31/2, 2016/1254-32, 2017/2379-32

Study design

Controlled pilot trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Not avaliable in web-format, please use the contact details below to request a patient information sheet

Condition

Lifestyle habits among families in socioeconomically disadvantaged settings.

Intervention

The study was designed as a controlled pilot study. All children in grade two (8-9 years), their siblings and their parents living in a socioeconomically disadvantaged municipality outside Stockholm were recruited through four schools. Families from two schools that had accepted an invitation to take part in the programme (intervention group) and families from two similar schools in the same area that had not yet implemented the programme (control group) were invited to participate in the study.

The duration of the intervention was nine months with four intervention components:
1. Activity sessions
2. Healthy meals
3. Health information
4. Parental support groups.

The families in the intervention group engaged in the activity sessions for one hour, twice a week, on one weekday and one weekend day. The activities were free of charge and coordinated by qualified health educators in cooperation with local organisations. At least one parent had to attend on each occasion. The activity sessions were followed by healthy meals and during the meal sessions, the health coordinator discussed different health themes. The parents were also invited to parental support group sessions which were led by qualified staff and organised by the municipality. The families in the control group were offered to participate in the programme after the intervention, one year later.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Physical activity measured with accelerometers (GT3X+, Actigragh, LCC, Pensacola, USA) for seven consecutive days.

Secondary outcome measures

Measurements in the children, their siblings and their parents have been carried out by trained research assistants.
1. Sedentary time measured with accelerometers (GT3X+, Actigraph, LCC, Pensacola, USA) for seven consecutive days
2. Physical activity habits and sedentary behaviour measured with a questionnaire
3. Height, weight, sagittal abdominal height, waist circumference and blood pressure measurements measured according to standardised procedures
4. Body composition measured with bioelectric impedance
5. Muscular strength measured with a maximal step-up test
6. Cardiorespiratory fitness measured with a step-up test (KPR-test).
7. Cardiovascular/metabolic risk factors; insulin, glucose, cholesterol, CRP and liver enzymes (ALAT/ASAT) measured in blood
8. Health related quality of life measured in children and their siblings (the Pediatric Quality of Life Inventory 4.0) and their parents (the Gothenburg Quality of Life Instrument)
9. Fidelity to the intervention measured by documenting the families’ participation in the programme
10. Psychosocial health and well-being explored by individual interviews with the parents and the children
11. Experiences of the programme explored by focus groups with the parents and the children
12. Facilitating factors for the participating families to continue being physically active after the intervention studied in the families by a questionnaire and by focus groups and individual interviews

Overall trial start date

10/01/2016

Overall trial end date

20/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Families with children in grade two (8-9 years) from two schools that had accepted an intervention to take part in the programme (intervention group) and families from two similar schools in the same area that had not yet implemented the programme (control group)

Participant type

All

Age group

Mixed

Gender

Both

Target number of participants

50-80 families

Participant exclusion criteria

If anyone in the family had already participated in the programme in an earlier school year

Recruitment start date

02/03/2016

Recruitment end date

20/12/2018

Locations

Countries of recruitment

Sweden

Trial participating centre

Karolinska Institutet, Department of Public Health Sciences
Tomtebodavägen 18 A
Stockholm
17177
Sweden

Sponsor information

Organisation

Karolinska Institutet

Sponsor details

Department of Public Health Sciences
Stockholm
17177
Sweden
004685240000
sekretariat@phs.ki.se

Sponsor type

University/education

Website

https://ki.se/en

Funders

Funder type

Not defined

Funder name

SKANDIA

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Swedish Heart-Lung Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The pilot trial results will be published in peer-reviewed scientific journals.
Three papers evaluating the effects of the intervention on physical activity, metabolic risk and quality of life will be published 2019- 2010.
A paper about participants psychosocial health will be published 2019- 2020 and a paper on facilitating factors for participating families to continue to be physically active after the intervention will be published in 2020.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. Data generated and analysed during the study are stored in KI ELN, an electronic notebook. Webpage: https://staff.ki.se/ki-eln-the-electronic-notebook?_ga=2.27139514.649422456.1567001962-595697067.1566049627
Type of stored data: ethical applications and approval, material used in data collection, raw data, data analysis files, important correspondence, research notes and publications.
Data storage and sharing: Data will be stored for 10 years and variables can be shared on relevant request, for example to other researchers doing systematic reviews.
Written informed consent has been obtained from all participants.
Anonymisation: All data is anonymised using a code for each participant. The code is stored separately from the data.
Legal restrictions: Sweden, as part of the European Union, adhere to the General Data Protection Regulation (GDPR).

Intention to publish date

01/11/2019

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/09/2019: Trial’s existence confirmed by Swedish Ethical Review Authority