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临床试验/NCT04668560
NCT04668560招募中不适用

Improving Wellbeing, Health and Work Adherence Effects of the 5 Ways to Wellbeing Course

Norwegian Institute of Public Health2 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
700
试验地点
2
主要终点
Wellbeing

研究概览

简要总结

Norway and other Western industrialized countries are facing major challenges in terms of preventable health problems, high work absence, largescale demographic changes and rising social inequalities in health. This project addresses the need for effective means to meet these important challenges. The project will scientifically evaluate The 5 Ways to Wellbeing course (5Ways), a novel measure aiming to promote wellbeing and integration, health and work adherence. Subjective wellbeing is systematically and prospectively related to important individual and societal outcomes, including social connectedness and integration, innovation, productivity, work performance, healthy behaviours, health and longevity. Promotion of wellbeing may therefore contribute to address the urgent societal ailments of today. Intervention effects and cost effectiveness of the 5Ways will be examined in-depth in four real-life settings, using quantitative methods. Specifically, we will investigate course impact wellbeing, health and work adherence among users of The Norwegian Labour and Welfare Administration (NAV) and clients in Healthy Life Centres. If effective, the course may be implemented nationwide and contribute to increase wellbeing and work participation. Findings from the study may thus contribute to enable municipalities and workplaces to make better priorities for promoting work presence, reducing suffering and improving mastery and quality of life among their inhabitants.

详细描述

Sample:

The sample consists of individuals attending the 5Ways course offered in Healthy Life Centres HLCs (N=500) and in NAV centres (N=100), and two groups of control subjects. The control groups include i) 1200 individuals participating in the FLS study and ii) 100 individuals in NAV receiving follow up as usual. The target group for the 5Ways course consists of individuals with, or at high risk of disease, who need support in health behaviour change and in coping with health problems and chronic disease. HLCs are interdisciplinary primary health care services that offer effective measures for people who need support in health behaviour change and in coping with health problems and chronic disease. All 5Ways course participants in HLCs will be invited to enrol in the study. In total, the investigators assume that altogether 500 participants from HLCs will be included in the study. The second group of course participants will include individuals on sick leave, work assessment allowance and disability pension who receive the 5Ways course through NAV. NAV currently administers a third of the national budget through schemes such as unemployment benefit, work assessment allowance, pensions, etc. The NAV participants will be randomised into an intervention group or a control group. Exclusion criteria for participation in the course include impaired cognitive functioning and severe mental illness.

The Course Intervention. The participants will attend the course for 2.5 hours across six weeks, one session dedicated to each of the five actions, and the last session for summarising, sharing and evaluating. The course is ready to be implemented. The course leaders are HLC coaches and NAV employees, with a minimum of three years of relevant education who are certified to run the 5Ways course. Course leader training consists of a two-day intensive, highly standardized training program. All course leaders receive a comprehensive manual to be followed through the course. The participants receive standardised course material.

The Pilot Study. During spring 2018, a pilot study was conducted on the 5Ways course in 12 HLCs in the South-Eastern part of Norway. A total of 89 participants completed the evaluation questionnaire. The evaluation report concluded that the participants were highly satisfied (score: 8.7/10), intended to continue to practice what they had learnt and experienced improved wellbeing.

Research hypotheses.

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

盲法说明

Behavioural intervention, masking N/A

入排标准

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

入选标准

  • individuals with, or at high risk of disease, who need support in health behaviour change and in coping with health problems and chronic disease.
  • individuals on sick leave, work assessment allowance (AAP) and disability pension

排除标准

  • Severe mental illhealth
  • impaired cognitive functioning

结局指标

主要结局

Wellbeing

时间窗: 15 months

Diener's Flourishing scale, 2 items Scores is from 8 (lowest possible wellbeing) to 56 (highest possible wellbeing).

次要结局

  • Mental health(15 months)
  • Mastery(15 months)
  • Social life(15 months)
  • Physical health(15 months)
  • Work participation(15 months)
  • Health care usage(15 months)

研究者

发起方
Norwegian Institute of Public Health
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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