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Study of Effectiveness of Different Lifestyle Interventions for Health and Wellbeing

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ClinicalTrials.gov Identifier: NCT01738256
Recruitment Status : Completed
First Posted : November 30, 2012
Last Update Posted : February 10, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Metabolic Syndrome Risk Factors Overweight Psychological Stress Behavioral: Wellbeing intervention (ACT) Behavioral: Wellbeing intervention (Internet) Behavioral: 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 339 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Applicability and Efficiency of Different Approaches in Lifestyle Interventions - Lifestyle Management and Changes in Everyday Life
Study Start Date : August 2012
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Psychological Flexibility (AAQ-2) [ Time Frame: Change from Baseline in Psychological Flexibility at 8.5 months ]

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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):
Responsible Party: University of Jyvaskyla
ClinicalTrials.gov Identifier: NCT01738256     History of Changes
Other Study ID Numbers: Salwe_27819_WP303.2-1
First Posted: November 30, 2012    Key Record Dates
Last Update Posted: February 10, 2014
Last Verified: February 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