Study of Effectiveness of Different Lifestyle Interventions for Health and Wellbeing

This study has been completed.

Sponsor:

Collaborators:

SalWe Ltd.

University of Eastern Finland

Helsinki University

VTT Technical Research Centre of Finland

Finnish Institute of Occupational Health

Finnish Red Cross

Duodecim Medical Publications Ltd.

Firstbeat Technologies Ltd.

Vivago Ltd

Valio Ltd

Information provided by (Responsible Party):

University of Jyvaskyla

ClinicalTrials.gov Identifier:

NCT01738256

First received: August 17, 2012

Last updated: February 7, 2014

Last verified: February 2014

History of Changes

Purpose

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.

Condition	Intervention
Metabolic Syndrome Risk Factors Overweight Psychological Stress	Behavioral: Wellbeing intervention (ACT) Behavioral: Wellbeing intervention (Internet) Behavioral: No intervention


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Applicability and Efficiency of Different Approaches in Lifestyle Interventions - Lifestyle Management and Changes in Everyday Life

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Abdominal Obesity Metabolic Syndrome

U.S. FDA Resources

Further study details as provided by University of Jyvaskyla:

Primary Outcome Measures:

Psychological Flexibility (AAQ-2) [ Time Frame: Change from Baseline in Psychological Flexibility at 8.5 months ]

Secondary Outcome Measures:

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


Enrollment:	339
Study Start Date:	August 2012
Study Completion Date:	December 2013
Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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


Ages Eligible for Study:	25 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738256

Locations


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

Sponsors and Collaborators

University of Jyvaskyla

SalWe Ltd.

University of Eastern Finland

Helsinki University

VTT Technical Research Centre of Finland

Finnish Institute of Occupational Health

Finnish Red Cross

Duodecim Medical Publications Ltd.

Firstbeat Technologies Ltd.

Vivago Ltd

Valio Ltd

Investigators


Principal Investigator:	Raimo Lappalainen, PhD	University of Jyvaskyla
Principal Investigator:	Marjukka Kolehmainen, PhD	University of Eastern Finland
Principal Investigator:	Miikka Ermes, PhD	VTT Technical Research Centre of Finland

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mattila E, Lappalainen R, Välkkynen 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, Järvelä E, Rantala S, Korpela R, Puttonen S, Kujala UM, Myllymäki T, Peuhkuri K, Mattila E, Kaipainen K, Ahtinen A, Karhunen L, Pihlajamäki J, Järnefelt 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.


Responsible Party:	University of Jyvaskyla
ClinicalTrials.gov Identifier:	NCT01738256 History of Changes
Other Study ID Numbers:	Salwe_27819_WP303.2-1
Study First Received:	August 17, 2012
Last Updated:	February 7, 2014

Keywords provided by University of Jyvaskyla:


Cognitive Behavior Therapy Acceptance Commitment Therapy Psychological Stress	Metabolic Syndrome Overweight Life Style

Additional relevant MeSH terms:


Overweight Metabolic Syndrome X Stress, Psychological Body Weight Signs and Symptoms	Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Behavioral Symptoms

ClinicalTrials.gov processed this record on July 17, 2017

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