Applicability and Efficiency of Different Approaches in Lifestyle Interventions - Lifestyle Management and Changes in Everyday Life
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Jyvaskyla
- Enrollment
- 339
- Locations
- 3
- Primary Endpoint
- Psychological Flexibility (AAQ-2)
Study Overview
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.
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Face-to-Face
Group meetings face-to-face using intervention for wellbeing with ACT principles.
Intervention: Wellbeing intervention (ACT) (Behavioral)
Mobile
Intervention for wellbeing via mobile phone application with ACT principles.
Intervention: Wellbeing intervention (ACT) (Behavioral)
Internet
Intervention for wellbeing via Internet (Virtual Health Check and Coaching).
Intervention: Wellbeing intervention (Internet) (Behavioral)
Control
Control group, no intervention.
Intervention: No intervention (Behavioral)
Outcomes
Primary Outcomes
Psychological Flexibility (AAQ-2)
Time Frame: Change from Baseline in Psychological Flexibility at 8.5 months
Secondary Outcomes
- Blood lipids(pre, post, follow-up (0, 10, 36))
- Diet (interview, questionnaire)(pre, post, follow-up (0, 10, 36 weeks))
- Depression(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))
- 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))