Study of Effectiveness of Different Lifestyle Interventions for Health and Wellbeing

NCT ID: NCT01738256

Last Updated: 2014-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

339 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Metabolic Syndrome Risk Factors Overweight Psychological Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Face-to-Face

Group meetings face-to-face using intervention for wellbeing with ACT principles.

Group Type EXPERIMENTAL

Wellbeing intervention (ACT)

Intervention Type BEHAVIORAL

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.

Mobile

Intervention for wellbeing via mobile phone application with ACT principles.

Group Type EXPERIMENTAL

Wellbeing intervention (ACT)

Intervention Type BEHAVIORAL

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.

Internet

Intervention for wellbeing via Internet (Virtual Health Check and Coaching).

Group Type EXPERIMENTAL

Wellbeing intervention (Internet)

Intervention Type BEHAVIORAL

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).

Control

Control group, no intervention.

Group Type EXPERIMENTAL

No intervention

Intervention Type BEHAVIORAL

No intervention

Interventions

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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.

Intervention Type 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).

Intervention Type BEHAVIORAL

No intervention

No intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SalWe Ltd.

INDUSTRY

Sponsor Role collaborator

University of Eastern Finland

OTHER

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role collaborator

VTT Technical Research Centre of Finland

OTHER

Sponsor Role collaborator

Finnish Institute of Occupational Health

OTHER

Sponsor Role collaborator

Finnish Red Cross Blood Service

OTHER

Sponsor Role collaborator

Duodecim Medical Publications Ltd.

INDUSTRY

Sponsor Role collaborator

Firstbeat Technologies Ltd.

INDUSTRY

Sponsor Role collaborator

Vivago Ltd

UNKNOWN

Sponsor Role collaborator

Valio Ltd

INDUSTRY

Sponsor Role collaborator

University of Jyvaskyla

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raimo Lappalainen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Jyvaskyla

Marjukka Kolehmainen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Eastern Finland

Miikka Ermes, PhD

Role: PRINCIPAL_INVESTIGATOR

VTT Technical Research Centre of Finland

Locations

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Institute of Biomedicine, University of Helsinki

Helsinki, , Finland

Site Status

Department of Psychology and Department of Health Sciences, University of Jyvaskyla

Jyväskylä, , Finland

Site Status

Institute of Public Health and Clinical Nutrition, University of Eastern Finland (UEF)

Kuopio, , Finland

Site Status

Countries

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Finland

References

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Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.

Reference Type DERIVED
PMID: 38375882 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34183032 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32394219 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29482636 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27468653 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24708617 (View on PubMed)

Other Identifiers

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Salwe_27819_WP303.2-1

Identifier Type: -

Identifier Source: org_study_id

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