Community With Immigrants - a Step on the Road to Employment

• ClinicalTrials.gov Identifier: NCT04725487
• Recruitment Status: Active, not recruiting
• First Posted: January 26, 2021
• Last Update Posted: January 26, 2021
• Sponsor: University College Absalon
• Collaborators: Team Integration, Næstved Municipality; Lærdansk, Danish Refugee Council; Den A.P. Møllerske Støttefond
• Information provided by (Responsible Party): University College Absalon

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Health Knowledge; Attitude to Health; Practice	Other: Standard integration program with social and health promoting intervention; Other: Standard integration program	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Community With Immigrants - a Step on the Road to Employment
• Actual Study Start Date: September 1, 2018
• Estimated Primary Completion Date: July 2021
• Estimated Study Completion Date: December 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. The Warwick-Edinburgh Mental Well-Being Scale - 7 items (WEMWBS) [ Time Frame: Change from baseline to 12 months and 24 months ]
   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.
2. Mean change from baseline in self-reported health [ Time Frame: Change from baseline to 12 months and 24 months ]

   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.

3. Mean change from baseline in cortisol, nmol/L [ Time Frame: Change from baseline to 24 months ]
   Cortisol measured in saliva
4. Mean change from baseline in blood sugar (HBA1C), mmol/mol [ Time Frame: Change from baseline to 24 months ]
   Blood sugar measured in venous blood
5. Mean change from baseline in total cholesterol, mmol/L [ Time Frame: Change from baseline to 24 months ]
   Total cholesterol measured in venous blood
6. Mean change from baseline in self-reported social relations [ Time Frame: Change from baseline to 12 months and 24 months ]
   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.
7. Change in employment status [ Time Frame: Change from baseline to 12 months and 24 months ]
   From unemployed to employed; from not being involved in education to being involved in education. Data from municipal registers.

Secondary Outcome Measures :

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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Denmark

Nina Odgaard Nielsen

Roskilde, Zealand, Denmark, 4000

Sponsors and Collaborators

University College Absalon

Team Integration, Næstved Municipality

Lærdansk, Danish Refugee Council

Den A.P. Møllerske Støttefond

Investigators

• Principal Investigator: Nina O Nielsen, Ph.d; University College Absalon (UCAbsalon)

More Information

• Responsible Party: University College Absalon
• ClinicalTrials.gov Identifier: NCT04725487
• Other Study ID Numbers: UCAbsalon
• First Posted: January 26, 2021
• Last Update Posted: January 26, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University College Absalon:

Refugee families; Social and health promoting intervention; Well-being; Employment; Integration