MIELITEKO Lifestyle Intervention Study

NCT05377398 | Completed

• 1 other identifier: 2116/02.03.01/2020
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (5)

• Change in Positive Mental Health (WEMWBS)

  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.

  At baseline, 6 and 12 months after baseline

• Change in Physical Activity

  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.

  At baseline, 6 and 12 months after baseline

• Change in Healthy Diet Index (HDI)

  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.

  At baseline, 6 and 12 months after baseline

• Change in Alcohol, Smoking and Substance Involvement (ASSIST)

  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.

  At baseline, 6 and 12 months after baseline

• Change in Pittsburgh Sleep Quality Index (PSQI)

  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.

  At baseline, 6 and 12 months after baseline

Secondary Outcomes (14)

• Beck Depression Inventory (BDI 21)

  At baseline, 6 and 12 months after baseline

• Beck Anxiety Inventory (BAI 21)

  At baseline, 6 and 12 months after baseline

• Psychotic symptoms

  At baseline, 6 and 12 months after baseline

• Social inclusion scale, THL

  At baseline, 6 and 12 months after baseline

• Resilience Scale (RS-14)

  At baseline, 6 and 12 months after baseline

Other Outcomes (1)

• Sociodemographic factors

  At baseline, 6 and 12 months after baseline

Study Arms (2)

1) Intervention group

EXPERIMENTAL

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.

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

2) Control group

NO INTERVENTION

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

Interventions

Digital individual-level intervention (Bit Habit) BEHAVIORAL

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.

1) Intervention group

Group-based healthy lifestyle and green power intervention BEHAVIORAL

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.

1) Intervention group

Individual-level healthy lifestyle intervention BEHAVIORAL

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.

1) Intervention group

Mini-intervention for substance use BEHAVIORAL

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.

1) Intervention group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \- no access to personal mobile devices or to the internet

Sponsors & Collaborators

• University of Eastern Finland: lead
• Savonia University of Applied Sciences (SAVONIA): collaborator
• City of Kuopio: collaborator
• VTT Technical Research Centre of Finland: collaborator
• Buddy Health Care (BHC): collaborator

Study Sites (5)

University of Eastern Finland

Kuopio, Northern Savonia, 70211, Finland

Location

Technical Research Centre of Finland (VTT)

Espoo, 02044, Finland

Location

Buddy HealthCare Ltd Oy

Helsinki, 24275, Finland

Location

Savonia University of Applied Sciences (SAVONIA)

Kuopio, 70201, Finland

Location

City of Kuopio

Kuopio, 70600, Finland

Location

Related Publications (12)

• Borodulin K, Laatikainen T, Lahti-Koski M, Jousilahti P, Lakka TA. Association of age and education with different types of leisure-time physical activity among 4437 Finnish adults. J Phys Act Health. 2008 Mar;5(2):242-51. doi: 10.1123/jpah.5.2.242.

  PMID: 18382033 BACKGROUND

• Borodulin K, Karki A, Laatikainen T, Peltonen M, Luoto R. Daily Sedentary Time and Risk of Cardiovascular Disease: The National FINRISK 2002 Study. J Phys Act Health. 2015 Jul;12(7):904-8. doi: 10.1123/jpah.2013-0364. Epub 2014 Aug 22.

  PMID: 25153761 BACKGROUND

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 BACKGROUND

• Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

  PMID: 12900694 BACKGROUND

• Harjumaa M, Absetz P, Ermes M, Mattila E, Mannikko R, Tilles-Tirkkonen T, Lintu N, Schwab U, Umer A, Leppanen J, Pihlajamaki J. Internet-Based Lifestyle Intervention to Prevent Type 2 Diabetes Through Healthy Habits: Design and 6-Month Usage Results of Randomized Controlled Trial. JMIR Diabetes. 2020 Aug 11;5(3):e15219. doi: 10.2196/15219.

  PMID: 32779571 BACKGROUND

• Hemio K, Polonen A, Ahonen K, Kosola M, Viitasalo K, Lindstrom J. A simple tool for diet evaluation in primary health care: validation of a 16-item food intake questionnaire. Int J Environ Res Public Health. 2014 Mar 4;11(3):2683-97. doi: 10.3390/ijerph110302683.

  PMID: 24599042 BACKGROUND

• Humeniuk R, Ali R, Babor T, Souza-Formigoni ML, de Lacerda RB, Ling W, McRee B, Newcombe D, Pal H, Poznyak V, Simon S, Vendetti J. A randomized controlled trial of a brief intervention for illicit drugs linked to the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) in clients recruited from primary health-care settings in four countries. Addiction. 2012 May;107(5):957-66. doi: 10.1111/j.1360-0443.2011.03740.x. Epub 2012 Feb 28.

  PMID: 22126102 BACKGROUND

• Lakka TA, Salonen JT. Intra-person variability of various physical activity assessments in the Kuopio Ischaemic Heart Disease Risk Factor Study. Int J Epidemiol. 1992 Jun;21(3):467-72. doi: 10.1093/ije/21.3.467.

  PMID: 1634307 BACKGROUND

• Lindstrom J, Aittola K, Polonen A, Hemio K, Ahonen K, Karhunen L, Mannikko R, Siljamaki-Ojansuu U, Tilles-Tirkkonen T, Virtanen E, Pihlajamaki J, Schwab U. Formation and Validation of the Healthy Diet Index (HDI) for Evaluation of Diet Quality in Healthcare. Int J Environ Res Public Health. 2021 Feb 28;18(5):2362. doi: 10.3390/ijerph18052362.

  PMID: 33670967 BACKGROUND

• Mollayeva T, Thurairajah P, Burton K, Mollayeva S, Shapiro CM, Colantonio A. The Pittsburgh sleep quality index as a screening tool for sleep dysfunction in clinical and non-clinical samples: A systematic review and meta-analysis. Sleep Med Rev. 2016 Feb;25:52-73. doi: 10.1016/j.smrv.2015.01.009. Epub 2015 Feb 17.

  PMID: 26163057 BACKGROUND

• Pihlajamaki J, Mannikko R, Tilles-Tirkkonen T, Karhunen L, Kolehmainen M, Schwab U, Lintu N, Paananen J, Jarvenpaa R, Harjumaa M, Martikainen J, Kohl J, Poutanen K, Ermes M, Absetz P, Lindstrom J, Lakka TA; StopDia study group. Digitally supported program for type 2 diabetes risk identification and risk reduction in real-world setting: protocol for the StopDia model and randomized controlled trial. BMC Public Health. 2019 Mar 1;19(1):255. doi: 10.1186/s12889-019-6574-y.

  PMID: 30823909 BACKGROUND

• Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.

  PMID: 18042300 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research director

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: May 17, 2022
• Study Start: August 24, 2022
• Primary Completion: August 31, 2023
• Study Completion: September 30, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After the planned study has ended.
• Access Criteria: For research purposes, persons interested to use the data can contact PI for research collaboration.

Locations

FI (5)