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
  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:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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
Genders Eligible for Study:   Both
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
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 Blood Service
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

No publications provided

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
Health Authority: Finland: Ethics Committee

Keywords provided by University of Jyvaskyla:
Cognitive Behavior Therapy
Acceptance Commitment Therapy
Psychological Stress
Metabolic Syndrome
Overweight
Life Style

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

ClinicalTrials.gov processed this record on April 17, 2014