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Clinical Trials/NCT01738256
NCT01738256
Completed
Not Applicable

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

University of Jyvaskyla3 sites in 1 country339 target enrollmentAugust 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metabolic Syndrome Risk Factors
Sponsor
University of Jyvaskyla
Enrollment
339
Locations
3
Primary Endpoint
Psychological Flexibility (AAQ-2)
Status
Completed
Last Updated
12 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
December 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

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))
  • 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))
  • Diet (interview, questionnaire)(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))

Study Sites (3)

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