Community With Immigrants - a Step on the Road to Employment

Attitude to Health Clinical Trial

Official title:

Community With Immigrants - a Step on the Road to Employment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04725487
• Other study ID #: UCAbsalon
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: July 31, 2021

Study information

• Verified date: January 2021
• Source: University College Absalon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Attitude to Health
• Health Knowledge
• Practice

Intervention

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

Locations

Country	Name	City	State
Denmark	Nina Odgaard Nielsen	Roskilde	Zealand

Sponsors (4)

Lead Sponsor	Collaborator
University College Absalon	Danish Refugee Council, Den A.P. Møllerske Støttefond, Naestved Municipality

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline to 12 months and 24 months
Primary	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.	Change from baseline to 12 months and 24 months
Primary	Mean change from baseline in cortisol, nmol/L	Cortisol measured in saliva	Change from baseline to 24 months
Primary	Mean change from baseline in blood sugar (HBA1C), mmol/mol	Blood sugar measured in venous blood	Change from baseline to 24 months
Primary	Mean change from baseline in total cholesterol, mmol/L	Total cholesterol measured in venous blood	Change from baseline to 24 months
Primary	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.	Change from baseline to 12 months and 24 months
Primary	Change in employment status	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	Mean change from baseline in Dihydepiandrosteron-sulfate (DHEAS), µmol/L	DHEAS measured in venous blood	Change from baseline to 24 months
Secondary	Mean change from baseline in interleukin-6 (IL-6), ng/L	IL-6 measured in venous blood	Change from baseline to 24 months
Secondary	Mean change from baseline in C-reactive protein (CRP), nmol/L	CRP measured in venous blood	Change from baseline to 24 months
Secondary	Mean change from baseline in fibrinogen (FIBR), g/L	FIBR measured in venous blood	Change from baseline to 24 months
Secondary	Mean change from baseline in weight	Weight (in kilograms). Weight is measured in kilograms	Change from baseline to 24 months
Secondary	Mean change from baseline in BMI	Weight and height (measured in meters) will be combined to report BMI in kg/meters2	Change from baseline to 24 months
Secondary	Mean change from baseline in blood pressure	Systolic and diastolic blood pressure (mmHg) will be measured using the Omron M3 blood pressure monitor.	Change from baseline to 24 months