Community With Immigrants - a Step on the Road to Employment

Sponsor
University College Absalon (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04725487
Collaborator
Team Integration, Næstved Municipality (Other), Lærdansk, Danish Refugee Council (Other), Den A.P. Møllerske Støttefond (Other)
120
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2
51
2.4

Study Details

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
  • Other: Standard integration program with social and health promoting intervention
  • Other: Standard integration program
N/A

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
Anticipated 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 :
Sep 1, 2018
Anticipated Primary Completion Date :
Jul 1, 2021
Anticipated Study Completion Date :
Dec 1, 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) [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 [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 [Change from baseline to 24 months]

    Cortisol measured in saliva

  4. Mean change from baseline in blood sugar (HBA1C), mmol/mol [Change from baseline to 24 months]

    Blood sugar measured in venous blood

  5. Mean change from baseline in total cholesterol, mmol/L [Change from baseline to 24 months]

    Total cholesterol measured in venous blood

  6. Mean change from baseline in self-reported social relations [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 [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 [Change from baseline to 24 months]

    DHEAS measured in venous blood

  2. Mean change from baseline in interleukin-6 (IL-6), ng/L [Change from baseline to 24 months]

    IL-6 measured in venous blood

  3. Mean change from baseline in C-reactive protein (CRP), nmol/L [Change from baseline to 24 months]

    CRP measured in venous blood

  4. Mean change from baseline in fibrinogen (FIBR), g/L [Change from baseline to 24 months]

    FIBR measured in venous blood

  5. Mean change from baseline in weight [Change from baseline to 24 months]

    Weight (in kilograms). Weight is measured in kilograms

  6. Mean change from baseline in BMI [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 [Change from baseline to 24 months]

    Systolic and diastolic blood pressure (mmHg) will be measured using the Omron M3 blood pressure monitor.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Site City State Country Postal Code
1 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)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University College Absalon
ClinicalTrials.gov Identifier:
NCT04725487
Other Study ID Numbers:
  • UCAbsalon
First Posted:
Jan 26, 2021
Last Update Posted:
Jan 26, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
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

Study Results

No Results Posted as of Jan 26, 2021