Study of Effectiveness of Different Lifestyle Interventions for Health and Wellbeing

University of Jyvaskyla339 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

339

Conditions

Metabolic Syndrome Risk Factors Overweight Psychological Stress

Interventions

Wellbeing intervention (ACT)BEHAVIORAL

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.

Wellbeing intervention (Internet)BEHAVIORAL

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).

No intervention

Eligibility

Sex: ALLMin age: 25 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (3)

Institute of Biomedicine, University of Helsinki

Helsinki, Finland

Department of Psychology and Department of Health Sciences, University of Jyvaskyla

Jyväskylä, Finland

Institute of Public Health and Clinical Nutrition, University of Eastern Finland (UEF)

Kuopio, Finland

Outcomes

Primary Outcomes

Psychological Flexibility (AAQ-2)

Time frame: Change from Baseline in Psychological Flexibility at 8.5 months

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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