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Wellbeing5WaysANCT04784871

Promoting Wellbeing: The Five Ways to All Intervention

A study testing 5waysA Intervention in people with Wellbeing and Health Attitude, run by University of Oslo at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 110 yearsHealthy volunteers can take part
Conditions the study is for
Wellbeing, Health Attitude, Quality of Life
What is being tested?
5waysA Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
970 participants
Where
1 siteNorway
Study dates
4 Mar 2021to 24 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 110 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • over 18 years old

Who cannot join

  • under 18 years old

Trial locations and contacts

1 site in 1 country.

Norway1 site
  • Monica Beer Prydz

    Asker, Norge, 1397

Other trials in Norway

About this study

Official title: Promoting Wellbeing: A Randomized Controlled Trial of the Five Ways to All Intervention

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?
  4. For whom is this intervention effective (i.e., is the effect moderated by e.g. gender, age, education)?
  5. 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.

Being tested
5waysA Intervention, 5waysA Active wait-list control, 5waysA Inactive wait-list control
Keywords
Wellbeing, Health promotion, Web-based intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5waysA InterventionBehavioural

    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.

  • 5waysA Active wait-list controlBehavioural

    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.

  • 5waysA Inactive wait-list controlBehavioural

    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.

Study groups in NCT04784871
Study groupRoleWhat they receive
5waysA InterventionExperimentalThe 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.
Receives: Behavioral: 5waysA Intervention
5waysA Active wait-list controlOtherThe 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
Receives: Behavioral: 5waysA Active wait-list control
5waysA Inactive wait-list controlOtherThe 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
Receives: Behavioral: 5waysA Inactive wait-list control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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).

    Measured: 12 months

Secondary outcomes (4)
  1. Mastery

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

    Measured: 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)

    Measured: 12 months

  3. Social life

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

    Measured: 12 months

  4. Physical health

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2021
  2. Study start4 Mar 2021
  3. Primary completion24 Feb 2023
  4. Study completion24 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The design is a randomized controlled trial (RCT) with one intervention group and two wait-list control groups. The goal with this design is to demonstrate the initial efficacy and feasibility of the 5WaysA intervention. We have one active control group writing activity log and one inactive not getting any tasks while waiting. The effect analysis will involve a comparison of self-reported wellbeing at different measurement points, using a two-way mixed measures ANOVA. In addition, PI will run a longitudinal analysis using linear mixed (multilevel) models on the data from all 5-6 measurement time points. Mixed modelling is a flexible way to handle unbalanced data in case of non-registration and repeated observations. The models allow PI to investigate the effects of the intervention and test the hypotheses of group and individual development in wellbeing while controlling for both stable and time-varying covariates.
Masking
None (open label)
Enrolment
970 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04784871
Sponsor's protocol ID
461814
Acronym
5WaysA
Status last verified
Mar 2023
First submitted
25 Feb 2021
Last updated
23 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Prydz MB, Czajkowski NO, Eilertsen M, Roysamb E, Nes RB. A Web-Based Intervention Using "Five Ways to Wellbeing" to Promote Well-Being and Mental Health: Randomized Controlled Trial. JMIR Ment Health. 2024 May 20;11:e49050. doi: 10.2196/49050.

    PubMed 38767958

Questions about this trial

What is this clinical trial studying?

A study testing 5waysA Intervention in people with Wellbeing and Health Attitude, run by University of Oslo at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wellbeing (Subjective wellbeing, global life satisfaction) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04784871, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.

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