Health KnowledgeNCT04725487
Community With Immigrants - a Step on the Road to Employment
A study testing Standard integration program with social and health promoting intervention and Standard integration program in people with Health Knowledge and Attitude to Health, run by University College Absalon at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Knowledge, Attitude to Health, Practice
- What is being tested?
- Standard integration program with social and health promoting intervention and Standard integration program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2018to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adult refugees aged 18 years and above
- Young refugees aged 13 -17 years
- Must have obtained Danish asylum and live in Naestved Municipality
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Health Knowledge, Attitude to Health, Practice
- Being tested
- Standard integration program with social and health promoting intervention, Standard integration program
- Keywords
- Refugee families, Social and health promoting intervention, Well-being, Employment, Integration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard integration program with social and health promoting interventionOther
- 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 programOther
Standard integration program (basic language course, internships, courses in Labour market knowledge and Danish culture)
| Study group | Role | What they receive |
|---|---|---|
| Standard integration program with social and health promoting intervention | Experimental | Participants follow the standard integration program offered by Naestved Municipality and participate in various social and health promoting activities in addition Receives: Other: Standard integration program with social and health promoting intervention |
| Standard integration program | Active comparator | Participants follow the standard integration program offered by Naestved Municipality Receives: Other: Standard integration program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Warwick-Edinburgh Mental Well-Being Scale - 7 items (WEMWBS)
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.
Measured: Change from baseline to 12 months and 24 months
Mean change from baseline in self-reported health
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.
Measured: Change from baseline to 12 months and 24 months
Mean change from baseline in cortisol, nmol/L
Cortisol measured in saliva
Measured: Change from baseline to 24 months
Mean change from baseline in blood sugar (HBA1C), mmol/mol
Blood sugar measured in venous blood
Measured: Change from baseline to 24 months
Mean change from baseline in total cholesterol, mmol/L
Total cholesterol measured in venous blood
Measured: Change from baseline to 24 months
Mean change from baseline in self-reported social relations
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.
Measured: Change from baseline to 12 months and 24 months
Change in employment status
From unemployed to employed; from not being involved in education to being involved in education. Data from municipal registers.
Measured: Change from baseline to 12 months and 24 months
Secondary outcomes (7)
Mean change from baseline in Dihydepiandrosteron-sulfate (DHEAS), µmol/L
DHEAS measured in venous blood
Measured: Change from baseline to 24 months
Mean change from baseline in interleukin-6 (IL-6), ng/L
IL-6 measured in venous blood
Measured: Change from baseline to 24 months
Mean change from baseline in C-reactive protein (CRP), nmol/L
CRP measured in venous blood
Measured: Change from baseline to 24 months
Mean change from baseline in fibrinogen (FIBR), g/L
FIBR measured in venous blood
Measured: Change from baseline to 24 months
Mean change from baseline in weight
Weight (in kilograms). Weight is measured in kilograms
Measured: Change from baseline to 24 months
Mean change from baseline in BMI
Weight and height (measured in meters) will be combined to report BMI in kg/meters2
Measured: Change from baseline to 24 months
Mean change from baseline in blood pressure
Systolic and diastolic blood pressure (mmHg) will be measured using the Omron M3 blood pressure monitor.
Measured: Change from baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Sep 2018
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health KnowledgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Absalon
- Sponsor type
- University, hospital or other
- Collaborators
- Naestved Municipality, Danish Refugee Council, Den A.P. Møllerske Støttefond
- Responsible party
- Sponsor
- Investigators
- Nina O Nielsen, Ph.d, Principal investigator, University College Absalon (UCAbsalon)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725487
- Sponsor's protocol ID
- UCAbsalon
- Status last verified
- Jan 2021
- First submitted
- 18 Dec 2020
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community With Immigrants - a Step on the Road to Employment
- ClinicalTrials.gov ID
- NCT04725487
- Acronym / sponsor ID
- UCAbsalon
- Conditions
- Health Knowledge, Attitude to Health, Practice
- Keywords
- Refugee families, Social and health promoting intervention, Well-being, Employment, Integration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University College AbsalonUniversity, hospital or other
- Collaborators
- Naestved Municipality, Danish Refugee Council, Den A.P. Møllerske Støttefond
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard integration program with social and health promoting intervention | Experimental | Other: Standard integration program with social and health promoting interventionParticipants follow the standard integration program offered by Naestved Municipality and participate in various social and health promoting activities in addition |
| Standard integration program | Active comparator | Other: Standard integration programParticipants follow the standard integration program offered by Naestved Municipality |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adult refugees aged 18 years and above
- Young refugees aged 13 -17 years
- Must have obtained Danish asylum and live in Naestved Municipality
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Standard integration program with social and health promoting intervention |
| Standard integration programStandard integration program (basic language course, internships, courses in Labour market knowledge and Danish culture) | Other | Standard integration program |
Primary outcome
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 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 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
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 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 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.
7 secondary outcomes
Mean change from baseline in Dihydepiandrosteron-sulfate (DHEAS), µmol/L
Time frame: 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
Mean change from baseline in C-reactive protein (CRP), nmol/L
Time frame: Change from baseline to 24 months
Mean change from baseline in fibrinogen (FIBR), g/L
Time frame: Change from baseline to 24 months
Mean change from baseline in weight
Time frame: Change from baseline to 24 months
Mean change from baseline in BMI
Time frame: Change from baseline to 24 months
Mean change from baseline in blood pressure
Time frame: Change from baseline to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina O Nielsen, Ph.d principal investigator
University College Absalon (UCAbsalon)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard integration program with social and health promoting intervention and Standard integration program in people with Health Knowledge and Attitude to Health, run by University College Absalon at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Warwick-Edinburgh Mental Well-Being Scale - 7 items (WEMWBS) (time frame: Change from baseline to 12 months and 24 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.