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Completed

NCT Number: NCT04725487

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.

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Key information

Conditions

Health Knowledge Attitude to Health Practice

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nina Odgaard Nielsen

Roskilde, Region Sjælland, 4000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard integration program with social and health promoting intervention

Other
  • 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

Standard integration program

Other

Standard integration program (basic language course, internships, courses in Labour market knowledge and Danish culture)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University College Absalon

Other

Collaborators

  • Danish Refugee Council
  • Den A.P. Møllerske Støttefond
  • Naestved Municipality

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 26, 2021
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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