Community With Immigrants - a Step on the Road to Employment

Study Overview
=================
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.

Official Title
-----------------
Community With Immigrants - a Step on the Road to Employment

Conditions
-----------------
Health Knowledge, Attitude to Health, Practice

Intervention / Treatment
-----------------
* Other: Standard integration program with social and health promoting intervention
* Other: Standard integration program


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard integration program with social and health promoting intervention<br>Participants follow the standard integration program offered by Naestved Municipality and participate in various social and health promoting activities in addition | Other: Standard integration program with social and health promoting intervention<br>* Basic language course, internships, courses in Labour market knowledge and Danish culture Physical activity workshops Community gardening (garden workshops) Entrepreneurship course MindSpring course Family excursions Danish language workshops<br>|
| Active Comparator: Standard integration program<br>Participants follow the standard integration program offered by Naestved Municipality | Other: Standard integration program<br>* Standard integration program (basic language course, internships, courses in Labour market knowledge and Danish culture)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Warwick-Edinburgh Mental Well-Being Scale - 7 items (WEMWBS) | WEMWBS is a validated measure of mental well-being and contains seven questions (a shortened version of the WEMWBS - 14 items). The scoring range for each item is from 1- 5, and the total score is from 7-35. The seven items have superior scaling properties to the 14 items, and mean raw scores are therefore transformed to metric scores using a standard conversion table. | Change from baseline to 12 months and 24 months | 
| Mean change from baseline in self-reported health | General health is assessed based on a question on self-reported health in the SF-12 questionnaire (a 12-Item short form health survey). SF 12 is a short version of the generic questionnaire SF 36 that measures health-related quality of life in the past four weeks. Scoring range is between 1-5 points. Mean score is calculated at baseline, 12 months and 24 months. | Change from baseline to 12 months and 24 months | 
| Mean change from baseline in cortisol, nmol/L | Cortisol measured in saliva | Change from baseline to 24 months | 
| Mean change from baseline in blood sugar (HBA1C), mmol/mol | Blood sugar measured in venous blood | Change from baseline to 24 months | 
| Mean change from baseline in total cholesterol, mmol/L | Total cholesterol measured in venous blood | Change from baseline to 24 months | 
| Mean change from baseline in self-reported social relations | Social relations are assessed based on five questions from the National Health Profile Survey (used in the Danish National Health Survey) in combination with one self-formulated question regarding contact with family members, friends, colleagues, neighbors and friends from social medias. Scoring range is between 1-5 points. Mean score is calculated at baseline, 12 months and 24 months. | Change from baseline to 12 months and 24 months | 
| Change in employment status | From unemployed to employed; from not being involved in education to being involved in education. Data from municipal registers. | Change from baseline to 12 months and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in Dihydepiandrosteron-sulfate (DHEAS), µmol/L | DHEAS measured in venous blood | Change from baseline to 24 months | 
| Mean change from baseline in interleukin-6 (IL-6), ng/L | IL-6 measured in venous blood | Change from baseline to 24 months | 
| Mean change from baseline in C-reactive protein (CRP), nmol/L | CRP measured in venous blood | Change from baseline to 24 months | 
| Mean change from baseline in fibrinogen (FIBR), g/L | FIBR measured in venous blood | Change from baseline to 24 months | 
| Mean change from baseline in weight | Weight (in kilograms). Weight is measured in kilograms | Change from baseline to 24 months | 
| Mean change from baseline in BMI | Weight and height (measured in meters) will be combined to report BMI in kg/meters2 | Change from baseline to 24 months | 
| Mean change from baseline in blood pressure | Systolic and diastolic blood pressure (mmHg) will be measured using the Omron M3 blood pressure monitor. | Change from baseline to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Refugee families, Social and health promoting intervention, Well-being, Employment, Integration