Clinical trial NCT05377398: MIELITEKO Lifestyle Intervention Study
Official title: Effective Promotion of Healthy Lifestyles, Mental Health and Wellbeing Among Disadvantaged Groups
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Well-Being
Life Style
Keywords: Mental health
Well-being
Life-style
Disadvantaged groups
intervention study
RCT
Mixed methods
Effectiveness
Registers
Digital intervention
Green power
Lead sponsor: University of Eastern Finland
Sponsor class: OTHER
Collaborators: name: Savonia University of Applied Sciences (SAVONIA)
name: City of Kuopio
name: VTT Technical Research Centre of Finland
name: Buddy Health Care (BHC)
First posted: 2022-05-17
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 64 years
* unemployed or outside the workforce (such as students)
* living in Northern Savo

Exclusion Criteria:

- no access to personal mobile devices or to the internet

Primary outcomes:
measure: Change in Positive Mental Health (WEMWBS)
timeFrame: At baseline, 6 and 12 months after baseline
measure: Change in Physical Activity
timeFrame: At baseline, 6 and 12 months after baseline
measure: Change in Healthy Diet Index (HDI)
timeFrame: At baseline, 6 and 12 months after baseline
measure: Change in Alcohol, Smoking and Substance Involvement (ASSIST)
timeFrame: At baseline, 6 and 12 months after baseline
measure: Change in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At baseline, 6 and 12 months after baseline
Secondary outcomes:
measure: Beck Depression Inventory (BDI 21)
timeFrame: At baseline, 6 and 12 months after baseline
measure: Beck Anxiety Inventory (BAI 21)
timeFrame: At baseline, 6 and 12 months after baseline
measure: Psychotic symptoms
timeFrame: At baseline, 6 and 12 months after baseline
measure: Social inclusion scale, THL
timeFrame: At baseline, 6 and 12 months after baseline
measure: Resilience Scale (RS-14)
timeFrame: At baseline, 6 and 12 months after baseline
measure: Capabilities (CA)
timeFrame: At baseline, 6 and 12 months after baseline
measure: UCLA loneliness scale
timeFrame: At baseline, 6 and 12 months after baseline
measure: Social cohesion
timeFrame: At baseline, 6 and 12 months after baseline
measure: The Alcohol Use Disorders Identification Test (AUDIT-C)
timeFrame: At baseline, 6 and 12 months after baseline
measure: Nature relationship
timeFrame: At baseline, 6 and 12 months after baseline
measure: Perceived health and illnesses
timeFrame: At baseline, 6 and 12 months after baseline
measure: Diseases diagnosed by a doctor
timeFrame: At baseline, 6 and 12 months after baseline
measure: Self-reported use of health and social care
timeFrame: At baseline, 6 and 12 months after baseline
measure: Register-based information of health and social service use and costs
timeFrame: At baseline, 6 and 12 months after baseline
Other outcomes:
measure: Sociodemographic factors
timeFrame: At baseline, 6 and 12 months after baseline
Locations:
city: Kuopio
country: Finland
facility: University of Eastern Finland
state: Northern Savo
city: Espoo
country: Finland
facility: Technical Research Centre of Finland (VTT)
city: Helsinki
country: Finland
facility: Buddy HealthCare Ltd Oy
city: Kuopio
country: Finland
facility: Savonia University of Applied Sciences (SAVONIA)
city: Kuopio
country: Finland
facility: City of Kuopio
Study officials:
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