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Clinical Trials/NCT04725487
NCT04725487
Completed
Not Applicable

Community With Immigrants - a Step on the Road to Employment

University College Absalon1 site in 1 country88 target enrollmentSeptember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Health Knowledge
Sponsor
University College Absalon
Enrollment
88
Locations
1
Primary Endpoint
The Warwick-Edinburgh Mental Well-Being Scale - 7 items (WEMWBS)
Status
Completed
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
July 31, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University College Absalon
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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.

Mean change from baseline in cortisol, nmol/L

Time Frame: Change from baseline to 24 months

Cortisol measured in saliva

Mean change from baseline in blood sugar (HBA1C), mmol/mol

Time Frame: Change from baseline to 24 months

Blood sugar measured in venous blood

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.

Mean change from baseline in total cholesterol, mmol/L

Time Frame: Change from baseline to 24 months

Total cholesterol measured in venous blood

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.

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.

Secondary Outcomes

  • Mean change from baseline in blood pressure(Change from baseline to 24 months)
  • Mean change from baseline in Dihydepiandrosteron-sulfate (DHEAS), µmol/L(Change from baseline to 24 months)
  • Mean change from baseline in C-reactive protein (CRP), nmol/L(Change from baseline to 24 months)
  • Mean change from baseline in fibrinogen (FIBR), g/L(Change from baseline to 24 months)
  • Mean change from baseline in BMI(Change from baseline to 24 months)
  • Mean change from baseline in interleukin-6 (IL-6), ng/L(Change from baseline to 24 months)
  • Mean change from baseline in weight(Change from baseline to 24 months)

Study Sites (1)

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