Promoting Wellbeing: The Five Ways to All Intervention
Condition: Wellbeing; Health Attitude; Quality of Life
Study type: Interventional

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).
    

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.
    

Intervention name(s): 5waysA Intervention; 5waysA Active wait-list control; 5waysA Inactive wait-list control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Prevention
Keywords: Wellbeing; Health promotion; Web-based intervention