MIELITEKO Lifestyle Intervention Study

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05377398
Study type	Interventional
Source	University of Eastern Finland
Contact
Status	Completed
Phase	N/A
Start date	August 24, 2022
Completion date	September 30, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

MIELITEKO Lifestyle Intervention Study — MIELITEKO

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms