Community With Immigrants - a Step on the Road to Employment

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.

Study Overview

• Status: Completed
• Conditions: Health Knowledge; Attitude to Health; Practice
• Intervention / Treatment: Other: Standard integration program with social and health promoting intervention; Other: Standard integration program

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Zealand
    • Roskilde, Zealand, Denmark, 4000
      • Nina Odgaard Nielsen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard integration program with social and health promoting intervention; 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; 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
Active Comparator: Standard integration program; Participants follow the standard integration program offered by Naestved Municipality	Other: Standard integration program; Standard integration program (basic language course, internships, courses in Labour market knowledge and Danish culture)

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

Collaborators and Investigators

• Sponsor: University College Absalon
• Collaborators: Den A.P. Møllerske Støttefond; Naestved Municipality; Danish Refugee Council
• Investigators: Principal Investigator: Nina O Nielsen, Ph.d, University College Absalon (UCAbsalon)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Well-being; Employment; Integration; Refugee families; Social and health promoting intervention
• Other Study ID Numbers: UCAbsalon

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No