Clinical trial NCT04725487: Community With Immigrants - a Step on the Road to Employment
Official title: Community With Immigrants - a Step on the Road to Employment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Knowledge
Attitude to Health
Practice
Keywords: Refugee families
Social and health promoting intervention
Well-being
Employment
Integration
Lead sponsor: University College Absalon
Sponsor class: OTHER
Collaborators: name: Naestved Municipality
name: Danish Refugee Council
name: Den A.P. Møllerske Støttefond
First posted: 2021-01-26
Enrollment: 88
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will investigate if a standard integration programme in combination with a social and health promoting intervention can increase health and well-being among refugee families and influence success with education and employment.

Detailed description: Increased health and well-being can lead to stronger motivation and ability to get involved in education or employment and thereby improve integration of refugee families.

The aim of the study is to investigate the effect of various social and health promoting activities such as physical activity workshops, community gardening, entrepreneurship training, MindSpring course, family excursions and language education on health, well-being, social relations and success with job and education. Increased success with self-sufficiency can support action competence and play a key role in the integration process. Outcome measures are based on self-reporting, biological measures and municipal registry data.

Eligibility criteria: Inclusion Criteria:

* Adult refugees aged 18 years and above
* Young refugees aged 13 -17 years
* Must have obtained Danish asylum and live in Naestved Municipality

Exclusion Criteria:

* Physical and/or mental illness which prevents the individual from participating in the integration program offered by Naestved Municipality
* Illness which does not allow collection of a venous blood sample and saliva sample.

Primary outcomes:
measure: The Warwick-Edinburgh Mental Well-Being Scale - 7 items (WEMWBS)
timeFrame: Change from baseline to 12 months and 24 months
measure: Mean change from baseline in self-reported health
timeFrame: Change from baseline to 12 months and 24 months
measure: Mean change from baseline in cortisol, nmol/L
timeFrame: Change from baseline to 24 months
measure: Mean change from baseline in blood sugar (HBA1C), mmol/mol
timeFrame: Change from baseline to 24 months
measure: Mean change from baseline in total cholesterol, mmol/L
timeFrame: Change from baseline to 24 months
measure: Mean change from baseline in self-reported social relations
timeFrame: Change from baseline to 12 months and 24 months
measure: Change in employment status
timeFrame: Change from baseline to 12 months and 24 months
Secondary outcomes:
measure: Mean change from baseline in Dihydepiandrosteron-sulfate (DHEAS), µmol/L
timeFrame: Change from baseline to 24 months
measure: Mean change from baseline in interleukin-6 (IL-6), ng/L
timeFrame: Change from baseline to 24 months
measure: Mean change from baseline in C-reactive protein (CRP), nmol/L
timeFrame: Change from baseline to 24 months
measure: Mean change from baseline in fibrinogen (FIBR), g/L
timeFrame: Change from baseline to 24 months
measure: Mean change from baseline in weight
timeFrame: Change from baseline to 24 months
measure: Mean change from baseline in BMI
timeFrame: Change from baseline to 24 months
measure: Mean change from baseline in blood pressure
timeFrame: Change from baseline to 24 months
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Nina Odgaard Nielsen
state: Zealand
Study officials:
affiliation: University College Absalon (UCAbsalon)
name: Nina O Nielsen, Ph.d
role: PRINCIPAL_INVESTIGATOR
References: