Clinical trial NCT01738256: Study of Effectiveness of Different Lifestyle Interventions for Health and Wellbeing
Official title: Applicability and Efficiency of Different Approaches in Lifestyle Interventions - Lifestyle Management and Changes in Everyday Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome Risk Factors
Overweight
Psychological Stress
Keywords: Cognitive Behavior Therapy
Acceptance Commitment Therapy
Psychological Stress
Metabolic Syndrome
Overweight
Life Style
Lead sponsor: University of Jyvaskyla
Sponsor class: OTHER
Collaborators: name: SalWe Ltd.
name: University of Eastern Finland
name: University of Helsinki
name: VTT Technical Research Centre of Finland
name: Finnish Institute of Occupational Health
name: Finnish Red Cross Blood Service
name: Duodecim Medical Publications Ltd.
name: Firstbeat Technologies Ltd.
name: Vivago Ltd
name: Valio Ltd
First posted: 2012-11-30
Enrollment: 339
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Psychological Flexibility (AAQ-2)
timeFrame: Change from Baseline in Psychological Flexibility at 8.5 months
Secondary outcomes:
measure: Diet (interview, questionnaire)
timeFrame: pre, post, follow-up (0, 10, 36 weeks)
measure: Perceived and physiological stress (questionnaire, heart rate variability measurement)
timeFrame: pre, post, follow-up (0, 10, 36 weeks)
measure: Blood lipids
timeFrame: pre, post, follow-up (0, 10, 36)
measure: Sleep (ESS, Basic Nordic Sleep Questionnaire, actigraphy, sleep diary)
timeFrame: pre, post, follow-up (0, 10, 36 weeks)
measure: Physical Activity (questionnaire)
timeFrame: pre, post, follow-up (0, 10, 36 weeks)
measure: User experiences concerning technology (interview, questionnaire)
timeFrame: during, post, follow-up (2, 10, 36 weeks)
measure: Depression
timeFrame: Pre, post, follow-up (0, 10, 36 weeks)
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Institute of Biomedicine, University of Helsinki
city: Jyvaskyla
country: Finland
facility: Department of Psychology and Department of Health Sciences, University of Jyvaskyla
city: Kuopio
country: Finland
facility: Institute of Public Health and Clinical Nutrition, University of Eastern Finland (UEF)
Study officials:
affiliation: University of Jyvaskyla
name: Raimo Lappalainen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Eastern Finland
name: Marjukka Kolehmainen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: VTT Technical Research Centre of Finland
name: Miikka Ermes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.