CClinicalTrials.gg
CompletedNCT047848715WaysAUpdated Mar 23, 2023

Promoting Wellbeing: The Five Ways to All Intervention

An interventional study of 5waysA Intervention and 5waysA Active wait-list control in Wellbeing, Health Attitude and Quality of Life, sponsored by University of Oslo. Completed at 1 site in Norway. Open to participants aged 18 Years to 110 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-23.

Sponsored by University of Oslo · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
970
Allocation
Randomized
Ages
18 Years to 110 Years
Sex
All
01

Study summary

This project is funded by Stiftelsen Dam and is a cooperation between The Norwegian Council for Mental Health (NCMH) and PROMENTA research group at the University of Oslo. Low-cost and evidence-based health promoting public health tools are urgently needed in Norwegian municipalities, to meet both current and future challenges with mental health and wellbeing. The aim in this randomized controlled trail is to test if a shorter, 10 week web-based version (The Five Ways to All, "5WaysA"), of an already established course (Five Ways to Wellbeing course), can promote wellbeing and mastery in the general population. The principal investigator will investigate to what extend the effects are short-term and long-term (i.e., 10 weeks, 18 weeks and 12 months after starting to receive the 5WaysA intervention).

Read the detailed description

Background:

The need for effective, low-cost and evidence-based tools to prevent illness and promote health in the population is paramount. Norway, along with other countries in the Western world, is currently facing major health and welfare-related challenges. Demographic changes, lifestyle related diseases and work absence are threatening the sustainability of the Norwegian welfare state. Non-communicable diseases, including mental illness, currently account for 65% of the total disease burden in Norway and 50% of Norwegians are likely to meet diagnostic criteria for a mental disorder some time during their life span. Traditional treatment and care options tend to be costly and time consuming, and to depend on highly skilled specialist human resources. Systematic findings also indicate that population-based (i.e., universal, targeting the general population) measures often result in larger population health gains than selective and indicated measures targeting only those with excess risk. According to the paradox of prevention, when disease risk is common, universal interventions directed towards the whole population before illness occurs, are more effective than interventions targeting high risk groups after symptoms have emerged. The Covid-19 pandemic and associated social distancing measures have corroborated the need for digital solutions. Web-based interventions may reach a large number of participants, utilizing a very modest amount of both human and financial resources.

The aim:

This study aims to test a potentially effective low-cost health and wellbeing promotive web-based intervention targeting the general population in Norwegian municipalities. The intervention is based on the Five Ways to Wellbeing framework developed for British health authorities in 2008. This framework, and the intervention to be tested, provides participants with knowledge on simple, sustainable activities that may strengthen their subjective wellbeing (SWB), mastery, health and social relations, thereby also reducing the risk of common mental health problems such as depression and anxiety. The study will be conducted in close collaboration with municipal stakeholders and important user groups. Thus, the principal investigator (PI) will investigate effects of a low-cost health and wellbeing promotive public health tool based on the evidence-base of Five Ways to Wellbeing. To date, nobody has tested the Five Ways-concept in such a format. Proved effective, this web-based 5WaysA intervention, may have a significant impact on the public health of inhabitants in the municipalities.

Main hypothesis:

The web-based intervention 5WaysA will improve wellbeing and mastery and hence provide the municipalities with an effective measure for mental health promotion.

Research questions:

  1. To what extent does participation in the web-based 5WaysA intervention lead to improved wellbeing, mental health and mastery in the general population?
  2. To what extent are the effects short-term and long-term (i.e., 10 weeks, 18 weeks and 12 months after starting to receive the 5WaysA intervention)?
  3. What mechanisms explain potential improvements in wellbeing?

    1. For whom is this intervention effective (i.e., is the effect moderated by e.g. gender, age, education)?
    2. What mechanisms (e.g., regular practicing of 5Ways actions, increased social activity or support) explain intervention effects?

Sample and recruitment:

The PI plan to recruit a minimum of 1500 participants from the general population in Norwegian municipalities. The participants will be randomized to either an intervention group (n=750), or to one of two wait-list control groups (active control, n=375) (inactive control, n =375). The wait-list control groups will receive the intervention three to five months later. The PI expect high drop-out (up to 50 %) since this has been the situation in other studies investigating online interventions in a general population. The PI is also unsure about how much time the municipalities have to help PI with the recruitment process, because of a high work load in the municipalities during the pandemic of Covid-19.

Note (June 19, 2021): PI was only able to recruit 226 participants in spring 2021. PI will continue the recruitment process and do another round of the intervention in fall 2021. This will not be registered as a new study, and is regarded as part of the current study

Procedures:

The web-based 10 week intervention consist of one main webinar (two hours at Zoom), a booster session webinar five weeks later and SMS messages twice a week in the the six following weeks. The webinars will be live lectures with an independent trained facilitator. The SMS messages will be sent out by the PI (via Nettskjema) to all participants while they are in the interventions period. Questionnaires will be administrated and distributed by the PI by using the Nettskjema and Services for sensitive data (TSD) tools. The measurements will also be conducted use of Nettskjema and TSD.

Power analysis:

The PI assume that we can recruit a minimum of 1500 participants, but high drop-out is expected. An a priori power analysis was conducted using G*Power3 to test the interaction effect in a mixed ANOVA, using a two-tailed test, assuming a small effect size (f = .10), and an alpha of .05. The assumed effect size (f=0.1) was chosen as it is of the same magnitude (lower bound) as has been reported by other universal interventions with wellbeing as the outcome measure. The result showed that if PI attained a total sample of 750 participants at the second measurement point (attrition of 50%), PI would have power of .999 to detect a group by time interaction. The high level of statistical power will enable PI to investigate both moderators and mediators of the treatment effect.

02

Conditions studied

  • Wellbeing
  • Health Attitude
  • Quality of Life

Keywords

  • Wellbeing
  • Health promotion
  • Web-based intervention
03

In context

Lead sponsor

University of Oslo is the lead sponsor of 176 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 110 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • over 18 years old

Exclusion criteria

Exclusion Criteria:

  • under 18 years old
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
970 participants (actual)

Study arms

  • Experimental
    5waysA Intervention

    The intervention, 5WaysA, is a 10 week modified web-based version of the original Five Ways to Wellbeing course. The intervention consists of a two-hour main webinar with live lecturing from a facilitator introducing the Five Ways to Wellbeing framework and teaching the participants how to implement the five health promotive activities in life, a booster session webinar four weeks later, as well as an SMS message twice a week in the six following weeks. Each SMS encourages participants to engage in one of the five activities, register activities/goals and queries about the degree of participation in the activity introduced in the previous SMS.

    Behavioral: 5waysA Intervention

  • Other
    5waysA Active wait-list control

    The active wait-list control group will get the same intervention as the interventions group, five months later. The active wait-list control group will be encouraged (in SMS messages) to write down an activity log once a week in ten weeks, while waiting. The participants in this group will also answer questionnaires after the intervention group has finished the intervention

    Behavioral: 5waysA Active wait-list control

  • Other
    5waysA Inactive wait-list control

    The inactive wait-list control group will get the same intervention as the interventions group, five months later. The inactive wait-list control group will not do anything specific while waiting for the intervention. The participants in this group will also answer questionnaires after the intervention group has finished the intervention

    Behavioral: 5waysA Inactive wait-list control

Interventions

  • Behavioral5waysA Intervention

    Web-based 10 week intervention, encouraging participants engaging in five potential health promoting activities: 1. Be active, 2. Take notice, 3. Keep learning, 4. Connect and 5. Give.

  • Behavioral5waysA Active wait-list control

    Writing activity log in the waiting time. Then, after five months and the writing of activity log, the participants get the web-based intervention and SMS massages, which encourage the participants to engage in five potential health promoting activities: 1. Be active, 2. Take notice, 3. Keep learning, 4. Connect and 5. Give.

  • Behavioral5waysA Inactive wait-list control

    No activity while the participants wait. After five months of waiting, the participants get the web-based intervention and SMS messages, which encourage participants engage in five potential health promoting activities: 1. Be active, 2. Take notice, 3. Keep learning, 4. Connect and 5. Give.

06

What researchers measure

Primary outcomes

  1. Wellbeing (Subjective wellbeing, global life satisfaction)

    Satisfaction With Life Scale (Diener, 2009) Scoring: 31 - 35 Extremely satisfied, 26 - 30 Satisfied, 21 - 25 Slightly satisfied, 20 Neutral,15 - 19 Slightly dissatisfied, 10 - 14 Dissatisfied and 5 - 9 Extremely dissatisfied

    Time frame: 12 months

  2. Wellbeing (Psychological wellbeing, self-perceived success in different aspects of life)

    Flourishing Scale (Diener et. al 2009). Scores from 8 (lowest possible wellbeing) to 56 (highest possible wellbeing).

    Time frame: 12 months

Secondary outcomes

  1. Mastery

    Pearlin and Schooler (1978). Scores from 7-49, the higher score the higher mastery.

    Time frame: 12 months

  2. Mental health (symptoms of depression and anxiety,)

    Hopkins Symptom Checklist-8 (HSCL-8). Scores from 0-32, the higher score the more symptoms (Tambs \& Røysamb, 2014)

    Time frame: 12 months

  3. Social life

    Oslo Social Support Scale-3 (OSS-3) Scores: 3-14, where high levels represent high levels of social support

    Time frame: 12 months

  4. Physical health

    Two questions from 12-Item Short Form Survey (SF-12) Scores: 12-47, where higher scores mean poorer health

    Time frame: 12 months

Other outcomes

  1. Work participation

    Single question

    Time frame: 12 months

  2. Five ways to wellbeing- activities: connect, keep learning, take notice and give.

    Four questions with scores in a range from 0 to 10, the higher score the more engaged in the activity.

    Time frame: 12 months

  3. Five ways to wellbeing- activity: be active. Frequency, duration and intensity.

    Three single questions from The Norwegian County Survey. Frequency; scores range from 0 to 6 (the higher score the more often physical active). Intensity; scores from 0-3 (the higher score the higher intensity). Duration: Scores from 0-4 (the higher score the longer duration)

    Time frame: 12 months

  4. Basic feelings

    Questions about feelings (happy, sad, irritated, lonely, engaged, calm, curious/interested). Scores rage from 0 to 10. 0 indicating not having the feeling at all, 10 indicating experience the feeling a lot.

    Time frame: 12 months

  5. Optimistic about the future

    On single question. Score from 0 to 10, the higher score the more optimistic

    Time frame: 12 months

07

Study locations

1 site
  • Monica Beer Prydz
    Asker, Norge 1397, Norway
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 25, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04784871
Lead sponsor
University of Oslo
Collaborators
Norwegian Institute of Public Health, Norwegian Council for Mental Health, The Dam Foundation
Responsible party
Monica Beer Prydz (Principal Investigator, University of Oslo) — Principal investigator
First posted
Mar 5, 2021
Start date
Mar 4, 2021
Primary completion
Feb 24, 2023
Completion
Feb 24, 2023
Last update
Mar 23, 2023

Study contacts

Monica B Prydz, Cand.psychol
principal investigator · University of Oslos

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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