Condition category
Not Applicable
Date applied
12/04/2019
Date assigned
16/05/2019
Last edited
17/05/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
For more than 100 years the private organization ‘Julemærkefonden’ has helped vulnerable children in Denmark, offering a ten week stay at one of their homes. In recent years the focus has been on well-being and overweight. ‘Julemærkefonden’ currently helps about 1000 children each year. The stay focuses on social relations, self-efficacy, self-esteem and healthy habits such as healthy food and physical activity.
The children apply for a stay themselves with help from their family, school and general practitioner. A doctor related to ‘Julemærkefonden’ reads the application and refers the child to the home, if the doctor believes the child will benefit from a stay.
Over the years ‘Julemærkefonden’ has been praised for doing a meaningful and important effort for vulnerable children in Denmark, but voices have also criticized that the efforts did not last after the children returned to their home environments. After a 10-week stay at a health camp we know that the children have higher life satisfaction and have a lower BMI. This effect wears off over time. This has never been documented.
To meet this criticism and because ‘Julemærkefonden’ wants to help the children both immediately but also in the long run, a new home- and community-based intervention has been developed at one of the homes ‘Liljeborg’. With this new intervention, it is the intention to support the child back into its home environment after a 10-week stay. This study aims to evaluate this new intervention.

Who can participate?
Children 7-14 years old who have participated in a 10-week camp focusing on lifestyle and well-being at one of the participating residential children's homes (Julemærkehjem).

What does the study involve?
The study is an external evaluation of a natural experiment: the home-based extended follow-up. It involves a total of five questionnaires for children participating in the 10-week health camp and receiving either the extended or the regular follow-up. The extended follow-up has been going on at Liljeborg for 1 - 5 years for the 10 allocated municipalities. The regular follow-up in its present form has been going on since 2015 after a stay at all of the homes. The study compares the extended follow-up to regular follow-up at Liljeborg and regular follow-up at the other four homes.

What are the possible benefits and risks of participating?
Benefits would be maintaining better life satisfaction and BMI. Risks are too much focus on well being and BMI which can be hard if the child is not doing good.

Where is the study run from?
The intervention is run by the private fund ‘Julemærkefonden’ at the Liljeborg home.

When is the study starting and how long is it expected to run for?
May 2019 to May 2020

Who is funding the study?
The Liljeborg Foundation (Liljeborg Fonden), Denmark

Who is the main contact?
Mette Kristoffersen, mekri@si-folkesundhed.dk

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Mette Kristoffersen

ORCID ID

http://orcid.org/0000-0003-2841-024X

Contact details

National Institute of Public Health
University of Southern Denmark
Studiestræde 6
Copenhagen
1455
Denmark
+45 65507777
mekri@si-folkesundhed.dk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

10.142

Study information

Scientific title

Does a 10-week home-based booster intervention maintain change in 7-14-year-old’s life satisfaction after a health camp compared to no-intervention control – a non-randomized trial

Acronym

Study hypothesis

An intervention supporting these children back into their home environment will improve the long-term outcome of the health camps measured by life satisfaction and BMI.

Ethics approval

According to Danish law an ethics approval is not needed in observational studies. We comply with all Danish legislation in this field.

Study design

Interventional controlled trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Home

Trial type

Quality of life

Patient information sheet

No participant information sheet available

Condition

Quality of life

Intervention

The home- and community-based intervention consists of 30 hours of support from a follow-up coordinator allocated to each child in the intervention group. The hours are spent focusing on the individual child’s needs, but the intervention always includes home visits. The intervention focuses on supporting exercise habits, dietary habits, social network, family culture and structure, coping strategies, leisure time and communities, school life and the general well-being of the child.

Two control groups are allocated. Control group 1: individuals from the same camp but without home intervention, Control group 2 from a comparable, but different camp and without home-based intervention following the camp.

In the intervention group, one of the four follow-up coordinators from Liljeborg is allocated to the involved child. The intervention allocates 30 hours per child distributed over 10 weeks. The intervention is needs-based and therefore flexible but encompasses e.g. home visits, school visits, coordination with resource people from the municipality, cross-disciplinary meetings across settings among other things. They use a self-developed ‘well-being-compass’ with eight focus areas: exercise habits, dietary habits, social network, family culture and structure, coping strategies, leisure time and communities, school life and the general well-being of the child to find out which areas the home-based intervention should focus on.

In the regular follow-up (13 of 23 municipalities) the children are allocated to one of four follow-up coordinators. They are contacted after the stay by telephone and the coordinator help the child and family with smaller, specific things if needed or help the family address their concern e.g. to the municipality.

This study includes a process and effect evaluation of the home and community-based extended follow-up intervention. I have developed a questionnaire which will be distributed to the children and their parents at all five homes before the initiation of the 10-week stay at a the home, after their stay at the home, four weeks after they come home, 12 weeks after they come home which is two weeks after the finalization of the follow-up intervention and 13 months after they get home from their stay. For the effect evaluation, the primary outcome is life satisfaction (Cantril ladder) and the secondary outcome is BMI.

Individuals are allocated to Intervention vs control individuals based on home municipality.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Life satisfaction in children 7-15 years old, measured by the Cantril ladder at the following points:
i. Two - five weeks before the 10-weeks health camp
ii. The last day of the health camp
iii. Four weeks after the health camp
iv. Three months after the health camp
v. 12 - 13 months after the health camp

Secondary outcome measures

BMI measured at the health camp by the personnel on their weight and self-reported through questionnaires at the following time points:
i. Beginning of 10-week health camp
ii. End of 10-week health camp
iii. Three months after health camp (self-reported)
iv. Liljeborg: 13 months after. The remaining four homes 12 months after (self-reported)

Overall trial start date

01/05/2017

Overall trial end date

20/09/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age 7-15 years
2. Participating in a 10-week camp focusing on lifestyle and well-being. The children have applied for the camp themselves together with their families and have been found to meet the inclusion criteria for the camp which are low quality of life with e.g. low self-esteem, bullying, few or no friends, social problems or overweight.

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

A total of approximately 240 children at the Liljeborg camp get the intervention over the period May 2019-May 2020. Approximately 120 children at the Liljeborg get the normal follow-up after the camp and approximately 120 get the home- and community-based intervention. A total of approximately 750 get the normal follow-up at the remaining four camps.

Participant exclusion criteria

1. Not eligible for a stay at the camp e.g. children with severe psychiatric diagnoses or behavioural disorders.

Recruitment start date

20/05/2019

Recruitment end date

20/05/2020

Locations

Countries of recruitment

Denmark

Trial participating centre

Julemærkehjemmet Liljeborg
Baldersvej 3
Roskilde
4000
Denmark

Trial participating centre

Julemærkehjemmet Hobro
Amerikavej 40
Hobro
9500
Denmark

Trial participating centre

Julemærkehjemmet Fjordmark
Fjordvejen 20 Kollund
Kruså
6340
Denmark

Trial participating centre

Julemærkehjemmet Kildemose
Kildemosevej 15
Ølsted
3310
Denmark

Trial participating centre

Julemærkehjemmet Skælskør
Møllebakken 5
Skælskør
4230
Denmark

Sponsor information

Organisation

National Institute of Public Health

Sponsor details

Studiestræde 6
Copenhagen K
1455
Denmark
+4565507783
mekri@si-folkesundhed.dk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Liljeborg Foundation (Liljeborg Fonden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

01/11/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

17/05/2019: Internal review. 15/05/2019: Trial’s existence confirmed by Liljeborgfonden