Study of Effectiveness of Different Lifestyle Interventions for Health and Wellbeing

Applicability and Efficiency of Different Approaches in Lifestyle Interventions - Lifestyle Management and Changes in Everyday Life

The purpose of this study is to examine the effectiveness and applicability of different interventions designed for enhancing overall wellbeing. Lifestyle changes, as well as psychological and physiological health variables are assessed. The interventions are based on the principles of cognitive behavioural therapy, and delivered either face-to-face, via mobile phone application, or Internet.

Study Overview

• Status: Completed
• Conditions: Overweight; Psychological Stress; Metabolic Syndrome Risk Factors
• Intervention / Treatment: Behavioral: No intervention; Behavioral: Wellbeing intervention (ACT); Behavioral: Wellbeing intervention (Internet)

Detailed Description

The study focuses on targeting overweight, stress, and impaired overall wellbeing with new cost-effective intervention methods. The intervention methods are based on the principles of cognitive behavioural therapy (CBT) and further acceptance-commitment therapy (ACT). The interventions are delivered either face-to-face, via mobile application, or via Internet. The purpose of each intervention is to improve the subjects lifestyles and activate them towards beneficial changes in their everyday life. The psychological and physiological effects of interventions are measured with various invasive and non-invasive methods. The study gives new insight into effectiveness and acceptability of up-to-date psychological intervention methods, and new knowledge of different ways to deliver interventions for improving wellbeing of an individual.

• Study Type: Interventional
• Enrollment (Actual): 339
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00290
    • Institute of Biomedicine, University of Helsinki
  • Jyvaskyla, Finland, 40014
    • Department of Psychology and Department of Health Sciences, University of Jyvaskyla
  • Kuopio, Finland, 80101
    • Institute of Public Health and Clinical Nutrition, University of Eastern Finland (UEF)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Body Mass Index (BMI) 27-34.9
• Psychological Stress (3/4 or 4/4 points in General Health Questionnaire)
• Possibility to use computer and internet connection

Exclusion Criteria:

• Diagnosed severe chronic illness

  • Symptomatic cardiovascular disease
  • Type 1 or 2 diabetes
  • Severe psychiatric conditions
  • Remarkable clinical operation within past 6 months
  • Heart attack or stroke within past 6 months
  • Kidney disease requiring Dialysis
• Regular use of cortisone pills
• Eating disorder: bulimia
• Disability pension for psychological reasons
• Pregnancy or breastfeeding within the pas 6 months
• Shift work (in three shifts) or night work
• Participation in other intervention studies during the present study

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Face-to-Face; Group meetings face-to-face using intervention for wellbeing with ACT principles.	Behavioral: Wellbeing intervention (ACT); The intervention is based on principles of acceptance-commitment therapy (ACT). It aims to increase psychological flexibility through different exercises that are developed for improving skills of being present, dealing with thoughts and feelings, as well as support clarifying individual values and value-based actions. In addition exercises for relaxation, physical activity, and mindful eating are provided. The content of intervention for face-to-face and mobile groups is similar but delivery method is different.
Experimental: Mobile; Intervention for wellbeing via mobile phone application with ACT principles.	Behavioral: Wellbeing intervention (ACT); The intervention is based on principles of acceptance-commitment therapy (ACT). It aims to increase psychological flexibility through different exercises that are developed for improving skills of being present, dealing with thoughts and feelings, as well as support clarifying individual values and value-based actions. In addition exercises for relaxation, physical activity, and mindful eating are provided. The content of intervention for face-to-face and mobile groups is similar but delivery method is different.
Experimental: Internet; Intervention for wellbeing via Internet (Virtual Health Check and Coaching).	Behavioral: Wellbeing intervention (Internet); The intervention is Duodecim Virtual Health Check and Coaching where the subject gets feedback based on his/her health information and is provided with different weekly tasks regarding lifestyle changes. The tasks are developed based on principles of cognitive behaviour therapy (CBT).
Experimental: Control; Control group, no intervention.	Behavioral: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Psychological Flexibility (AAQ-2)	Change from Baseline in Psychological Flexibility at 8.5 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Diet (interview, questionnaire)	pre, post, follow-up (0, 10, 36 weeks)
Perceived and physiological stress (questionnaire, heart rate variability measurement)	pre, post, follow-up (0, 10, 36 weeks)
Blood lipids	pre, post, follow-up (0, 10, 36)
Sleep (ESS, Basic Nordic Sleep Questionnaire, actigraphy, sleep diary)	pre, post, follow-up (0, 10, 36 weeks)
Physical Activity (questionnaire)	pre, post, follow-up (0, 10, 36 weeks)
User experiences concerning technology (interview, questionnaire)	during, post, follow-up (2, 10, 36 weeks)
Depression	Pre, post, follow-up (0, 10, 36 weeks)

Collaborators and Investigators

• Sponsor: University of Jyvaskyla
• Collaborators: University of Helsinki; University of Eastern Finland; VTT Technical Research Centre of Finland; Finnish Institute of Occupational Health; Valio Ltd; Duodecim Medical Publications Ltd.; Finnish Red Cross Blood Service; SalWe Ltd.; Firstbeat Technologies Ltd.; Vivago Ltd
• Investigators: Principal Investigator: Raimo Lappalainen, PhD, University of Jyväskylä; Principal Investigator: Marjukka Kolehmainen, PhD, University of Eastern Finland; Principal Investigator: Miikka Ermes, PhD, VTT Technical Research Centre of Finland

Publications and helpful links

General Publications

• Jarvela-Reijonen E, Jarvinen S, Karhunen L, Fohr T, Myllymaki T, Sairanen E, Lindroos S, Peuhkuri K, Hallikainen M, Pihlajamaki J, Puttonen S, Korpela R, Ermes M, Lappalainen R, Kujala UM, Kolehmainen M, Laitinen J. Sleep-time physiological recovery is associated with eating habits in distressed working-age Finns with overweight: secondary analysis of a randomised controlled trial. J Occup Med Toxicol. 2021 Jun 28;16(1):23. doi: 10.1186/s12995-021-00310-6.
• Jarvela-Reijonen E, Puttonen S, Karhunen L, Sairanen E, Laitinen J, Kolehmainen M, Pihlajamaki J, Kujala UM, Korpela R, Ermes M, Lappalainen R, Kolehmainen M. The Effects of Acceptance and Commitment Therapy (ACT) Intervention on Inflammation and Stress Biomarkers: a Randomized Controlled Trial. Int J Behav Med. 2020 Oct;27(5):539-555. doi: 10.1007/s12529-020-09891-8.
• Jarvela-Reijonen E, Karhunen L, Sairanen E, Muotka J, Lindroos S, Laitinen J, Puttonen S, Peuhkuri K, Hallikainen M, Pihlajamaki J, Korpela R, Ermes M, Lappalainen R, Kolehmainen M. The effects of acceptance and commitment therapy on eating behavior and diet delivered through face-to-face contact and a mobile app: a randomized controlled trial. Int J Behav Nutr Phys Act. 2018 Feb 27;15(1):22. doi: 10.1186/s12966-018-0654-8.
• Mattila E, Lappalainen R, Valkkynen P, Sairanen E, Lappalainen P, Karhunen L, Peuhkuri K, Korpela R, Kolehmainen M, Ermes M. Usage and Dose Response of a Mobile Acceptance and Commitment Therapy App: Secondary Analysis of the Intervention Arm of a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2016 Jul 28;4(3):e90. doi: 10.2196/mhealth.5241.
• Lappalainen R, Sairanen E, Jarvela E, Rantala S, Korpela R, Puttonen S, Kujala UM, Myllymaki T, Peuhkuri K, Mattila E, Kaipainen K, Ahtinen A, Karhunen L, Pihlajamaki J, Jarnefelt H, Laitinen J, Kutinlahti E, Saarelma O, Ermes M, Kolehmainen M. The effectiveness and applicability of different lifestyle interventions for enhancing wellbeing: the study design for a randomized controlled trial for persons with metabolic syndrome risk factors and psychological distress. BMC Public Health. 2014 Apr 4;14:310. doi: 10.1186/1471-2458-14-310.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: August 17, 2012
• First Submitted That Met QC Criteria: November 27, 2012
• First Posted (Estimate): November 30, 2012

Study Record Updates

• Last Update Posted (Estimate): February 10, 2014
• Last Update Submitted That Met QC Criteria: February 7, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Overweight; Metabolic Syndrome; Acceptance Commitment Therapy; Cognitive Behavior Therapy; Life Style; Psychological Stress
• Additional Relevant MeSH Terms: Behavioral Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Body Weight; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome; Stress, Psychological; Overweight
• Other Study ID Numbers: Salwe_27819_WP303.2-1