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 Blood Service
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

August 17, 2012
February 7, 2014
August 2012
December 2013   (final data collection date for primary outcome measure)
Psychological Flexibility (AAQ-2) [ Time Frame: Change from Baseline in Psychological Flexibility at 8.5 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01738256 on ClinicalTrials.gov Archive Site
  • Diet (interview, questionnaire) [ Time Frame: pre, post, follow-up (0, 10, 36 weeks) ] [ Designated as safety issue: No ]
  • Perceived and physiological stress (questionnaire, heart rate variability measurement) [ Time Frame: pre, post, follow-up (0, 10, 36 weeks) ] [ Designated as safety issue: No ]
  • Blood lipids [ Time Frame: pre, post, follow-up (0, 10, 36) ] [ Designated as safety issue: No ]
  • Sleep (ESS, Basic Nordic Sleep Questionnaire, actigraphy, sleep diary) [ Time Frame: pre, post, follow-up (0, 10, 36 weeks) ] [ Designated as safety issue: No ]
  • Physical Activity (questionnaire) [ Time Frame: pre, post, follow-up (0, 10, 36 weeks) ] [ Designated as safety issue: No ]
  • User experiences concerning technology (interview, questionnaire) [ Time Frame: during, post, follow-up (2, 10, 36 weeks) ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: Pre, post, follow-up (0, 10, 36 weeks) ] [ Designated as safety issue: No ]
  • Diet (interview, questionnaire) [ Time Frame: pre, post, follow-up (0, 10, 36 weeks) ] [ Designated as safety issue: No ]
  • Perceived and physiological stress (questionnaire, heart rate variability measurement) [ Time Frame: pre, post, follow-up (0, 10, 36 weeks) ] [ Designated as safety issue: No ]
  • Blood lipids [ Time Frame: pre, post, follow-up (0, 10, 36) ] [ Designated as safety issue: No ]
  • Sleep (ESS, Basic Nordic Sleep Questionnaire, actigraphy, sleep diary) [ Time Frame: pre, post, follow-up (0, 10, 36 weeks) ] [ Designated as safety issue: No ]
  • Physical Activity (questionnaire) [ Time Frame: pre, post, follow-up (0, 10, 36 weeks) ] [ Designated as safety issue: No ]
  • User experiences concerning technology (interview, questionnaire) [ Time Frame: during, post, follow-up (2, 10, 36 weeks) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • Metabolic Syndrome Risk Factors
  • Overweight
  • Psychological Stress
  • 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.
  • 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).
  • Behavioral: No intervention
    No intervention
  • Experimental: Face-to-Face
    Group meetings face-to-face using intervention for wellbeing with ACT principles.
    Intervention: Behavioral: Wellbeing intervention (ACT)
  • Experimental: Mobile
    Intervention for wellbeing via mobile phone application with ACT principles.
    Intervention: Behavioral: Wellbeing intervention (ACT)
  • Experimental: Internet
    Intervention for wellbeing via Internet (Virtual Health Check and Coaching).
    Intervention: Behavioral: Wellbeing intervention (Internet)
  • Experimental: Control
    Control group, no intervention.
    Intervention: Behavioral: No intervention
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
339
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
25 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01738256
Salwe_27819_WP303.2-1
No
University of Jyvaskyla
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 Blood Service
  • Duodecim Medical Publications Ltd.
  • Firstbeat Technologies Ltd
  • Vivago Ltd
  • Valio Ltd
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
University of Jyvaskyla
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP