MIELITEKO Lifestyle Intervention Study

University of Eastern Finland

Status: Completed

Conditions: Well-Being; Life Style; Mental Health

Treatments: Behavioral: Group-based healthy lifestyle and green power intervention; Behavioral: Mini-intervention for substance use; Behavioral: Digital individual-level intervention (Bit Habit); Behavioral: Individual-level healthy lifestyle intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05377398

2116/02.03.01/2020

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

1) Intervention group

Experimental group

Description:

Participants in this arm will be offered 1. a digital individual-level intervention (Bit Habit) \& 2. group-based or individual-level healthy lifestyle and green power intervention 3. a mini-intervention for substance use if their level of substance use is above certain risk level.

Treatment:

Behavioral: Digital individual-level intervention (Bit Habit)

Behavioral: Individual-level healthy lifestyle intervention

Behavioral: Mini-intervention for substance use

Behavioral: Group-based healthy lifestyle and green power intervention

2) Control group

No Intervention group

Description:

The control group is assumed to continue with current health information and national recommendations for healthy lifestyle and use of services "as usual".