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Study of Effectiveness of Different Lifestyle Interventions for Health and Wellbeing

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01738256
Enrollment
339
Registered
2012-11-30
Start date
2012-08-31
Completion date
2013-12-31
Last updated
2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome Risk Factors, Overweight, Psychological Stress

Keywords

Cognitive Behavior Therapy, Acceptance Commitment Therapy, Psychological Stress, Metabolic Syndrome, Overweight, Life Style

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.

Interventions

BEHAVIORALWellbeing 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.

BEHAVIORALWellbeing 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).

BEHAVIORALNo intervention

No intervention

Sponsors

SalWe Ltd.
CollaboratorINDUSTRY
University of Eastern Finland
CollaboratorOTHER
University of Helsinki
CollaboratorOTHER
VTT Technical Research Centre of Finland
CollaboratorOTHER
Finnish Institute of Occupational Health
CollaboratorOTHER
Finnish Red Cross Blood Service
CollaboratorOTHER
Duodecim Medical Publications Ltd.
CollaboratorINDUSTRY
Firstbeat Technologies Ltd.
CollaboratorINDUSTRY
Vivago Ltd
CollaboratorUNKNOWN
Valio Ltd
CollaboratorINDUSTRY
University of Jyvaskyla
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frame
Psychological Flexibility (AAQ-2)Change from Baseline in Psychological Flexibility at 8.5 months

Secondary

MeasureTime frame
Perceived and physiological stress (questionnaire, heart rate variability measurement)pre, post, follow-up (0, 10, 36 weeks)
Blood lipidspre, post, follow-up (0, 10, 36)
Sleep (ESS, Basic Nordic Sleep Questionnaire, actigraphy, sleep diary)pre, post, follow-up (0, 10, 36 weeks)
Diet (interview, questionnaire)pre, post, follow-up (0, 10, 36 weeks)
User experiences concerning technology (interview, questionnaire)during, post, follow-up (2, 10, 36 weeks)
DepressionPre, post, follow-up (0, 10, 36 weeks)
Physical Activity (questionnaire)pre, post, follow-up (0, 10, 36 weeks)

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026