Study of Effectiveness of Different Lifestyle Interventions for Health and Wellbeing

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01738256
• Other study ID #: Salwe_27819_WP303.2-1
• Status: Completed
• Phase: N/A
• First received: August 17, 2012
• Last updated: February 7, 2014
• Start date: August 2012
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: University of Jyvaskyla
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Metabolic Syndrome Risk Factors
• Metabolic Syndrome X
• Overweight
• Psychological Stress
• Stress, Psychological

Intervention

Behavioral:
• Wellbeing 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.
• Wellbeing 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).
• No intervention
No intervention

Locations

Country	Name	City	State
Finland	Institute of Biomedicine, University of Helsinki	Helsinki
Finland	Department of Psychology and Department of Health Sciences, University of Jyvaskyla	Jyvaskyla
Finland	Institute of Public Health and Clinical Nutrition, University of Eastern Finland (UEF)	Kuopio

Sponsors (11)

Lead Sponsor	Collaborator
University of Jyvaskyla	Duodecim Medical Publications Ltd., Finnish Institute of Occupational Health, Finnish Red Cross, Firstbeat Technologies Ltd., Helsinki University, SalWe Ltd., University of Eastern Finland, Valio Ltd, Vivago Ltd, VTT Technical Research Centre of Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological Flexibility (AAQ-2)		Change from Baseline in Psychological Flexibility at 8.5 months	No
Secondary	Diet (interview, questionnaire)		pre, post, follow-up (0, 10, 36 weeks)	No
Secondary	Perceived and physiological stress (questionnaire, heart rate variability measurement)		pre, post, follow-up (0, 10, 36 weeks)	No
Secondary	Blood lipids		pre, post, follow-up (0, 10, 36)	No
Secondary	Sleep (ESS, Basic Nordic Sleep Questionnaire, actigraphy, sleep diary)		pre, post, follow-up (0, 10, 36 weeks)	No
Secondary	Physical Activity (questionnaire)		pre, post, follow-up (0, 10, 36 weeks)	No
Secondary	User experiences concerning technology (interview, questionnaire)		during, post, follow-up (2, 10, 36 weeks)	No
Secondary	Depression		Pre, post, follow-up (0, 10, 36 weeks)	No