A healthy generation: a programme to promote physical activity and a healthy lifestyle in children and their families in socioeconomically disadvantaged areas

ISRCTN	ISRCTN11660938
DOI	https://doi.org/10.1186/ISRCTN11660938
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Karolinska Institutet
Funders	SKANDIA, The Swedish Heart-Lung Foundation

Submission date: 26/08/2019
Registration date: 23/09/2019
Last edited: 06/11/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Gisela Nyberg
Scientific

Karolinska Insitutet
Solnavägen 1E
Stockholm
113 65
Sweden

ORCID ID	0000-0003-0004-8533
Phone	+46766009179
Email	Gisela.Nyberg@ki.se

Study information

Primary study design	Interventional
Study design	Controlled pilot trial
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	A Healthy Generation - a programme to promote physical activity and a healthy lifestyle in children and their families in socioeconomically disadvantaged areas
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Physical activity measured with accelerometers (GT3X+, Actigragh, LCC, Pensacola, USA) for seven consecutive days.
Key secondary outcome measure(s)	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
Completion date	20/12/2018

Eligibility

Participant type(s)	All
Age group	Mixed
Sex	All
Target sample size at registration	50
Total final enrolment	67
Key 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)
Key exclusion criteria	If anyone in the family had already participated in the programme in an earlier school year
Date of first enrolment	02/03/2016
Date of final enrolment	20/12/2018

Locations

Countries of recruitment

Sweden

Study participating centre

Karolinska Institutet, Department of Public Health Sciences

Tomtebodavägen 18 A
Stockholm
17177
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in repository
IPD sharing plan	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).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	29/05/2020	01/06/2020	Yes	No
Results article	results	14/12/2020	16/12/2020	Yes	No
Results article	Primary and secondary outcomes	27/05/2020	06/11/2023	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

06/11/2023: Publication reference added.
16/12/2020: Publication reference added.
01/06/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
02/09/2019: Trial’s existence confirmed by Swedish Ethical Review Authority