NCT04668560

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 16, 2020

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

5.4 years

First QC Date

December 2, 2020

Last Update Submit

January 14, 2025

Conditions

WellbeingQuality of LifeMental Health Wellness 1

Outcome Measures

Primary Outcomes (3)

  • Wellbeing

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

    15 months

  • Wellbeing

    Satisfaction With Life Scale (SWLS) scoring: 31 - 35 Extremely satisfied 26 - 30 Satisfied 21 - 25 Slightly satisfied 20 Neutral 15 - 19 Slightly dissatisfied 10 - 14 Dissatisfied 5 - 9 Extremely dissatisfied

    15 months

  • Wellbeing

    WHO-5

    15 months

Secondary Outcomes (6)

  • Mental health

    15 months

  • Mastery

    15 months

  • Social life

    15 months

  • Physical health

    15 months

  • Work participation

    15 months

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Course intervention, six weeks wellbeing course

Behavioral: Five ways to wellbeing course

Control

NO INTERVENTION

Follow-up as usual

Interventions

Five ways to wellbeing courseBEHAVIORAL

A behavioural course over six sessions. Teaching the participants in doing avtivities to promote wellbeing

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Severe mental illhealth
  • impaired cognitive functioning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian Institute of Public Health

Oslo, 0473, Norway

RECRUITING

Study Officials

  • Anne Reneflot, PhD

    Department Director

    STUDY CHAIR

Central Study Contacts

Maja ME Eilertsen, MD

CONTACT

+47 95895434maja.eilertsen@fhi.no

Ragnhild RN Bang Nes, PhD

CONTACT

+ 47 92481863raba@fhi.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Behavioural intervention, masking N/A
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomised controlled trial
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2020

First Posted

December 16, 2020

Study Start

February 1, 2020

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

January 16, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)