MIELITEKO Lifestyle Intervention Study
Condition: Mental Health; Well-Being; Life Style
Study type: Interventional

Summary: 
      Mental health problems cause individual, social and economic burden to the society. The
      mental health problems are among the highest levels in North Savo compared to the general
      Finnish population. The COVID-19 pandemic has emphasized the urgent need for tackling mental
      health problems and developing an effective and comprehensive approach to prevent mental
      health problems. The aim of this MIELITEKO pilot study is to test and develop an effective
      and comprehensive programme to prevent mental health problems and promote mental wellbeing
      among disadvantaged groups.

      The pilot study is a multilayered intervention study with an RCT study design, which will be
      conducted in selected cities and areas in North Savo such as Kuopio, Iisalmi, Varkaus and
      Siilinjärvi. The disadvantaged groups of this study include people aged between 18 and 64
      years who are unemployed or are outside the workforce. The participants are randomized 1:1
      into intervention (N=250) and control groups (N=250). The intervention group will receive the
      multilayered intervention whereas the control group is assumed to continue with current
      health information and use of services "as usual" but remain in the waiting list.
      Multilayered intervention includes individual-level digital healthy lifestyle intervention,
      group-based healthy lifestyle intervention and green power intervention as well as
      mini-intervention for substance use.

      The data collection of self-reported validated measure of health and wellbeing as well as
      relevant background factor will be conducted using digital and online survey tools in
      baseline (T0), and after 6 months (T1) and 12 months (T2) after the onset of the study from
      both intervention and control groups. Register data on the use of services and
      pharmaceuticals that will be gathered from the national registers at National Institute for
      Health and Welfare and Kela or from local registers administered by municipalities in North
      Savo. Pilot study will utilize quantitative and qualitative statistical analyses to evaluate
      the process, effects and effectiveness as well as cost-effectiveness of the intervention to
      promote mental health and wellbeing as well as to healthy lifestyles.
    


Intervention name(s): Digital individual-level intervention (Bit Habit); Group-based healthy lifestyle and green power intervention; Individual-level healthy lifestyle intervention; Mini-intervention for substance use
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): All participants in the intervention group receive access to the BitHabit app for the 1-year intervention period. The BitHabit app was designed in the StopDia project, and it aims to help its users to adopt healthier lifestyles and habits.The content and approach of the app is based on habit formation theories and the Self-Determination Theory. The app provides an extensive library of suggested lifestyle habits that was created according to lifestyle guidelines and recommendations. The habits are related to diet, physical activity, sleep, positive mood, stress management, smoking, and alcohol consumption. Users of the app select these habits from the library to their "shopping basket" to complete in their everyday life. The app also allows the users to report and monitor their performance and progress.; The group-based healthy lifestyle intervention is based on the Supportive Environment Theory (SET). The intervention is implemented in accordance with DiClemente and Prochaska's Stages-of-Change Model which is often used as framework for lifestyle change as well as Shazer and Berg's Solution Focused Brief Therapy. We expect participants to increase knowledge about healthy lifestyle choices and notice the beneficial effect of exercise, healthy diet and staying in nature. The intervention includes 12 to 16 hours of group activities during a period of 8 weeks. Interventions comprehend guided activities in nature, related to healthy relationship to food and exercise, as well as reflecting on shared experiences. In addition to group meetings, participants have access to material for mental well-being on an electronic learning environment.; The individual-level healthy lifestyle intervention follows the principles and theoretical background of the group-based intervention, but the intervention is carried out entirely on the electronic learning environment. The participants complete activities and exercises independently or with a friend in their own time.; The mini-intervention for substance use follows the principle of the ASSIST-linked brief intervention created by WHO. This brief intervention is a phone-call lasting 3 to 15 minutes and given to the participant according to their risk score calculated with the ASSIST questionnaire which is included in the baseline survey. The intervention includes presenting the participant with their test score and associated health problems related to their level of risk. Especially in primary health care context, brief intervention according to the ASSIST score has been found to be successful in moderating risk for substance use. The intervention is not intended as a stand-alone treatment and in cases where high risk substance use is detected, the professional should encourage the participant to seek specialized drug and alcohol assessment and treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is a multilayered intervention study with RCT study design. The selection of participants will be based on purposive sampling. The participants will fill in the baseline questionnaire that screens the current state of mental health, mental wellbeing and healthy lifestyle and substance use among the participants.
Participants are then randomly allocated 1:1 to intervention (N=250) and control groups (N=250). The participants in the intervention group are offered 1) Digital individual-level intervention and 2) Individual-level or group-based intervention. In addition, all participants in the intervention group with elevated risk for substance use will also be targeted with 3) A mini-intervention for substance use.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Mental health; Well-being; Life-style; Disadvantaged groups; intervention study; RCT; Mixed methods; Effectiveness; Registers; Digital intervention; Green power