MIELITEKO Lifestyle Intervention Study

Not Applicable

Completed

• Conditions: Well-Being; Mental Health; Life Style
• Interventions: Behavioral: Digital individual-level intervention (Bit Habit); Behavioral: Group-based healthy lifestyle and green power intervention; Behavioral: Individual-level healthy lifestyle intervention; Behavioral: Mini-intervention for substance use

• Registration Number: NCT05377398
• Lead Sponsor: University of Eastern Finland

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-25
• Study First Submitted QC: 2022-05-11
• Study First Posted: 2022-05-17
• Study Start: 2022-08-24
• Primary Completion: 2023-08-31
• Study Completion: 2023-09-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

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

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Exclusion Criteria

• no access to personal mobile devices or to the internet

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1) Intervention group	Individual-level healthy lifestyle intervention	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.
1) Intervention group	Digital individual-level intervention (Bit Habit)	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.
1) Intervention group	Group-based healthy lifestyle and green power intervention	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.
1) Intervention group	Mini-intervention for substance use	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.

Primary Outcome Measures

Name	Time	Method
Change in Alcohol, Smoking and Substance Involvement (ASSIST)	At baseline, 6 and 12 months after baseline	Alcohol consumption, smoking and other substance use are assessed in the survey with WHO's validated ASSIST questionnaire. In the questionnaire we inquire whether the respondent has used listed substances during their lifetime or in the past three months and how often they have had a strong urge to use them. We also inquire whether the respondent has faced health, social, legal or financial difficulties because of their substance use, their friends or relatives have raised concerns or they themselves have wished to stop using the substance. The measure for alcohol, smoking and substance abuse is calculated according to the principles of the ASSIST screening tool.
Change in Positive Mental Health (WEMWBS)	At baseline, 6 and 12 months after baseline	The definitive target of the healthy lifestyle intervention is an increase in measured positive mental health. The positive mental health of the respondents will be assessed with a self-reported validated measure of the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS).; The measure consists of 14 5-point Likert scale items, where the respondent states how often during the past two weeks they have felt as described in the proposed statement (none of the time, rarely, some of the time, often, all the time). The items cover positive affect (feelings of optimism, cheerfulness, relaxation), satisfying interpersonal relationships and positive functioning (energy, clear thinking, self-acceptance, personal development, competence and autonomy). All the items are scored positively according to the Likert scale value, giving a minimum score of 14 and maximum score of 70. Higher score indicates a higher level of mental well-being.
Change in Physical Activity	At baseline, 6 and 12 months after baseline	Physical activity is measured with assessment tools adopted from StopDia. In StopDia study, the questions regarding physical activity were modified from the Finrisk study, the Kuopio Ischaemic Heart Disease Risk Factor study and the International Physical Activity Questionnaire.; We inquire how often and with what duration the respondents carry out planned physical activity and exercise. We also inquire with similar questions the frequency of incidental activity, for example walking the stairs or gardening. Our outcome measure of physical activity is the total time used during a week for planned or incidental conditioning and everyday physical activities.
Change in Healthy Diet Index (HDI)	At baseline, 6 and 12 months after baseline	Diet quality and eating behaviors are assessed in the survey using the Healthy Diet Index (HDI). The Healthy Diet Index (HDI) was developed as part of the StopDia project to assess the quality of a diet. The index is a modification of the 18-Item Food Intake Questionnaire (D2D-FIQ). The index consists of seven domains: meal patterns, intake of grains, fruits and vegetables, fats, fish and meat, dairy and snacks and treats. The index is scored as a total score of the domains with a maximum score of 100 points.
Change in Pittsburgh Sleep Quality Index (PSQI)	At baseline, 6 and 12 months after baseline	For assessment of sleep quality, we use the well-validated Pittsburgh Sleep Quality Index (PSQI). We inquire the typical times the respondent falls asleep and wakes up on weekdays and weekends. We also ask them how easy it is for them to fall asleep and if they wake up during the night. Additionally, we survey different symptoms and effects of sleep dysfunction according to the Pittsburg Sleep Quality questionnaire. Our outcome measure for sleep quality is the global PSQI score.

Secondary Outcome Measures

Name	Time	Method
Beck Depression Inventory (BDI 21)	At baseline, 6 and 12 months after baseline	Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Higher score means higher depression.
Beck Anxiety Inventory (BAI 21)	At baseline, 6 and 12 months after baseline	The Beck Anxiety Inventory (BAI) consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms during the past week. Higher score means higher anxiety.
Resilience Scale (RS-14)	At baseline, 6 and 12 months after baseline	Finnish version of the resilience scale (RS-14), shortened version of RS developed by Wagnild \& Young 1993. Include 14 individual items, total score range from 14-98, higher score means higher resilience.
Nature relationship	At baseline, 6 and 12 months after baseline	perceived wellbeing and health effects of the nature, including individual items on health, positive feelings, stress, importance of nature, as well as how often spends time in nature and how much per each visit. Scale for each is Likert-5, daily-once o months, not spending time - hour or more
Psychotic symptoms	At baseline, 6 and 12 months after baseline	Psychotic-like experiences, Scale: Youth experiences and Health, Short version, developed by the Finnish Institute for Health and Welfare (THL), higher scores to worse to outcome.
Capabilities (CA)	At baseline, 6 and 12 months after baseline	Finnish versio of the capabilities scale (CA), developed by the Anand et al 2005, include 7 individual items plus summary question, scale from 1 to 7, total score is calculated by summarizing the 7 individual items, higher score means better capabilities.
UCLA loneliness scale	At baseline, 6 and 12 months after baseline	Finnish version of the UCLA loneliness scale (Russell et al 1996), that measure Subjective feelings of loneliness as well as feelings of social isolation. Short-version, summary score in which higher scores means severe loneliness.
Social cohesion	At baseline, 6 and 12 months after baseline	General instrument to measure trust to public institutes (government, policy, health and social care, ) and other people with a scale from 1 (low) to 5 (high trust). Summary score of these individual items presented general trust (social cohesion) to public institutes or other people. Higher score presents higher social cohesion.
Register-based information of health and social service use and costs	At baseline, 6 and 12 months after baseline	National and local register information of the use of social and health services as well as medicines will be linked to the data, including use and costs of the services and medicines
Social inclusion scale, THL	At baseline, 6 and 12 months after baseline	Survey instrument to assess self-reported experiences of social inclusion, summary score from individual items, scaled to 0-100, higher score means higher inclusion.
Self-reported use of health and social care	At baseline, 6 and 12 months after baseline	Use of various health and social services during the last 12 months, scale: yes or no, how many times
The Alcohol Use Disorders Identification Test (AUDIT-C)	At baseline, 6 and 12 months after baseline	The AUDIT-C measures whether the person's drinking is affecting his or her health and safety. Scale is scored between 0 (no use) and 12. Higher the score higher the more likely drinking is affecting health and safety of the person.
Diseases diagnosed by a doctor	At baseline, 6 and 12 months after baseline	A long list of various diseases diagnosed by a doctor, scale yes or no.
Perceived health and illnesses	At baseline, 6 and 12 months after baseline	persons general perception of their health and illnesses, scale (very food) 1-5 (very poor)

Trial Locations

Locations (5)

Technical Research Centre of Finland (VTT); 🇫🇮 Espoo, Finland

Savonia University of Applied Sciences (SAVONIA); 🇫🇮 Kuopio, Finland

Buddy HealthCare Ltd Oy; 🇫🇮 Helsinki, Finland

City of Kuopio; 🇫🇮 Kuopio, Finland

University of Eastern Finland; 🇫🇮 Kuopio, Northern Savo, Finland