Study of Effectiveness of Different Lifestyle Interventions for Health and Wellbeing

Study Overview
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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.

Official Title
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Applicability and Efficiency of Different Approaches in Lifestyle Interventions - Lifestyle Management and Changes in Everyday Life

Conditions
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Metabolic Syndrome Risk Factors, Overweight, Psychological Stress

Intervention / Treatment
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* Behavioral: Wellbeing intervention (ACT)
* Behavioral: Wellbeing intervention (Internet)
* Behavioral: No intervention


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Face-to-Face<br>Group meetings face-to-face using intervention for wellbeing with ACT principles. | Behavioral: Wellbeing intervention (ACT)<br>* 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.<br>|
| Experimental: Mobile<br>Intervention for wellbeing via mobile phone application with ACT principles. | Behavioral: Wellbeing intervention (ACT)<br>* 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.<br>|
| Experimental: Internet<br>Intervention for wellbeing via Internet (Virtual Health Check and Coaching). | Behavioral: Wellbeing intervention (Internet)<br>* 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).<br>|
| Experimental: Control<br>Control group, no intervention. | Behavioral: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological Flexibility (AAQ-2) |  | Change from Baseline in Psychological Flexibility at 8.5 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Behavior Therapy, Acceptance Commitment Therapy, Psychological Stress, Metabolic Syndrome, Overweight, Life Style