Skip to main content
OpenTrials
Completed

NCT Number: NCT01738256

Study of Effectiveness of Different Lifestyle Interventions for Health and Wellbeing

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metabolic Syndrome Risk Factors Behavior Behavioral Symptoms Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Psychological Stress Signs and Symptoms Stress, Psychological

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Biomedicine, University of Helsinki, Helsinki, Finland

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wellbeing intervention (ACT)

Behavioral

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)

Behavioral

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

Behavioral

No intervention

Primary outcomes

  1. Psychological Flexibility (AAQ-2)

    Time frame: Change from Baseline in Psychological Flexibility at 8.5 months

Secondary outcomes

  1. Diet (interview, questionnaire)

    Time frame: pre, post, follow-up (0, 10, 36 weeks)

  2. Perceived and physiological stress (questionnaire, heart rate variability measurement)

    Time frame: pre, post, follow-up (0, 10, 36 weeks)

  3. Blood lipids

    Time frame: pre, post, follow-up (0, 10, 36)

  4. Sleep (ESS, Basic Nordic Sleep Questionnaire, actigraphy, sleep diary)

    Time frame: pre, post, follow-up (0, 10, 36 weeks)

  5. Physical Activity (questionnaire)

    Time frame: pre, post, follow-up (0, 10, 36 weeks)

  6. User experiences concerning technology (interview, questionnaire)

    Time frame: during, post, follow-up (2, 10, 36 weeks)

  7. Depression

    Time frame: Pre, post, follow-up (0, 10, 36 weeks)

Sponsors and collaborators

Lead sponsor

University of Jyvaskyla

Other

Collaborators

  • Duodecim Medical Publications Ltd.
  • Finnish Institute of Occupational Health
  • Finnish Red Cross Blood Service
  • Firstbeat Technologies Ltd.
  • SalWe Ltd.
  • University of Eastern Finland
  • University of Helsinki
  • VTT Technical Research Centre of Finland
  • Valio Ltd
  • Vivago Ltd

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 30, 2012
Registry last updated
Feb 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.