Community With Immigrants - a Step on the Road to Employment

May 16, 2023 updated by: University College Absalon
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to 12 months and 24 months
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.
Change from baseline to 12 months and 24 months
Mean change from baseline in cortisol, nmol/L
Time Frame: Change from baseline to 24 months
Cortisol measured in saliva
Change from baseline to 24 months
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 from baseline to 24 months
Mean change from baseline in total cholesterol, mmol/L
Time Frame: Change from baseline to 24 months
Total cholesterol measured in venous blood
Change from baseline to 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.
Change from baseline to 12 months and 24 months
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.
Change from baseline to 12 months and 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean change from baseline in Dihydepiandrosteron-sulfate (DHEAS), µmol/L
Time Frame: Change from baseline to 24 months
DHEAS measured in venous blood
Change from baseline to 24 months
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
Change from baseline to 24 months
Mean change from baseline in C-reactive protein (CRP), nmol/L
Time Frame: Change from baseline to 24 months
CRP measured in venous blood
Change from baseline to 24 months
Mean change from baseline in fibrinogen (FIBR), g/L
Time Frame: Change from baseline to 24 months
FIBR measured in venous blood
Change from baseline to 24 months
Mean change from baseline in weight
Time Frame: Change from baseline to 24 months
Weight (in kilograms). Weight is measured in kilograms
Change from baseline to 24 months
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
Change from baseline to 24 months
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.
Change from baseline to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University College Absalon

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Den A.P. Møllerske Støttefond
Naestved Municipality
Danish Refugee Council

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nina O Nielsen, Ph.d, University College Absalon (UCAbsalon)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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