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临床试验/NCT04725487
NCT04725487已完成不适用

Community With Immigrants - a Step on the Road to Employment

University College Absalon2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
88
试验地点
2
主要终点
The Warwick-Edinburgh Mental Well-Being Scale - 7 items (WEMWBS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
13 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult refugees aged 18 years and above
  • Young refugees aged 13 -17 years
  • Must have obtained Danish asylum and live in Naestved Municipality

排除标准

  • 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.

结局指标

主要结局

The Warwick-Edinburgh Mental Well-Being Scale - 7 items (WEMWBS)

时间窗: 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

时间窗: Change from baseline to 24 months

Cortisol measured in saliva

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

时间窗: Change from baseline to 24 months

Blood sugar measured in venous blood

Change in employment status

时间窗: 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

时间窗: Change from baseline to 24 months

Total cholesterol measured in venous blood

Mean change from baseline in self-reported health

时间窗: 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

时间窗: 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.

次要结局

  • 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)

研究者

发起方
University College Absalon
申办方类型
Other
责任方
Sponsor

研究点 (2)

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