Study of Effectiveness of Different Lifestyle Interventions for Health and Wellbeing

Not Applicable

Completed

• Conditions: Metabolic Syndrome Risk Factors; Overweight; Psychological Stress
• Interventions: Behavioral: Wellbeing intervention (ACT); Behavioral: Wellbeing intervention (Internet); Behavioral: No intervention

• Registration Number: NCT01738256
• Lead Sponsor: University of Jyvaskyla

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 Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-17
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-30
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-07
• Last Update Posted: 2014-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 339

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Face-to-Face	Wellbeing intervention (ACT)	Group meetings face-to-face using intervention for wellbeing with ACT principles.
Mobile	Wellbeing intervention (ACT)	Intervention for wellbeing via mobile phone application with ACT principles.
Internet	Wellbeing intervention (Internet)	Intervention for wellbeing via Internet (Virtual Health Check and Coaching).
Control	No intervention	Control group, no intervention.

Primary Outcome Measures

Name	Time	Method
Psychological Flexibility (AAQ-2)	Change from Baseline in Psychological Flexibility at 8.5 months

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (3)

Institute of Biomedicine, University of Helsinki; 🇫🇮 Helsinki, Finland

Institute of Public Health and Clinical Nutrition, University of Eastern Finland (UEF); 🇫🇮 Kuopio, Finland

Department of Psychology and Department of Health Sciences, University of Jyvaskyla; 🇫🇮 Jyvaskyla, Finland