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Metabolic Syndrome Risk FactorsNCT01738256

Study of Effectiveness of Different Lifestyle Interventions for Health and Wellbeing

A study testing Wellbeing intervention (ACT) and Wellbeing intervention (Internet) in people with Metabolic Syndrome Risk Factors and Overweight, run by University of Jyvaskyla at 3 sites in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 25 to 60 years
What is being tested?
Wellbeing intervention (ACT) and Wellbeing intervention (Internet)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
339 participants
Where
3 sitesFinland
Study dates
Aug 2012to Dec 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Finland3 sites

  • Institute of Biomedicine, University of Helsinki

    Helsinki, 00290

  • Department of Psychology and Department of Health Sciences, University of Jyvaskyla

    Jyväskylä, 40014

  • Institute of Public Health and Clinical Nutrition, University of Eastern Finland (UEF)

    Kuopio, 80101

Other trials in Finland

About this study

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

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.

Read the 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.

Being tested
Wellbeing intervention (ACT), Wellbeing intervention (Internet), No intervention
Keywords
Cognitive Behavior Therapy, Acceptance Commitment Therapy, Psychological Stress, Metabolic Syndrome, Overweight, Life Style
Medical subject headings
Overweight, Stress, Psychological, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wellbeing intervention (ACT)Behavioural

    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)Behavioural

    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 interventionBehavioural

    No intervention

Study groups in NCT01738256
Study groupRoleWhat they receive
Face-to-FaceExperimentalGroup meetings face-to-face using intervention for wellbeing with ACT principles.
Receives: Behavioral: Wellbeing intervention (ACT)
MobileExperimentalIntervention for wellbeing via mobile phone application with ACT principles.
Receives: Behavioral: Wellbeing intervention (ACT)
InternetExperimentalIntervention for wellbeing via Internet (Virtual Health Check and Coaching).
Receives: Behavioral: Wellbeing intervention (Internet)
ControlExperimentalControl group, no intervention.
Receives: Behavioral: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Psychological Flexibility (AAQ-2)

    Measured: Change from Baseline in Psychological Flexibility at 8.5 months

Secondary outcomes (7)

  1. Diet (interview, questionnaire)

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

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

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

  3. Blood lipids

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

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

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

  5. Physical Activity (questionnaire)

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

  6. User experiences concerning technology (interview, questionnaire)

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

  7. Depression

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
339 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01738256
Sponsor's protocol ID
Salwe_27819_WP303.2-1
Status last verified
Feb 2014
First submitted
17 Aug 2012
Last updated
10 Feb 2014
Results posted
No
Data monitoring committee
No

Publications

  • Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.

    PubMed 38375882

  • Jarvela-Reijonen E, Jarvinen S, Karhunen L, Fohr T, Myllymaki T, Sairanen E, Lindroos S, Peuhkuri K, Hallikainen M, Pihlajamaki J, Puttonen S, Korpela R, Ermes M, Lappalainen R, Kujala UM, Kolehmainen M, Laitinen J. Sleep-time physiological recovery is associated with eating habits in distressed working-age Finns with overweight: secondary analysis of a randomised controlled trial. J Occup Med Toxicol. 2021 Jun 28;16(1):23. doi: 10.1186/s12995-021-00310-6.

    PubMed 34183032

  • Jarvela-Reijonen E, Puttonen S, Karhunen L, Sairanen E, Laitinen J, Kolehmainen M, Pihlajamaki J, Kujala UM, Korpela R, Ermes M, Lappalainen R, Kolehmainen M. The Effects of Acceptance and Commitment Therapy (ACT) Intervention on Inflammation and Stress Biomarkers: a Randomized Controlled Trial. Int J Behav Med. 2020 Oct;27(5):539-555. doi: 10.1007/s12529-020-09891-8.

    PubMed 32394219

  • Jarvela-Reijonen E, Karhunen L, Sairanen E, Muotka J, Lindroos S, Laitinen J, Puttonen S, Peuhkuri K, Hallikainen M, Pihlajamaki J, Korpela R, Ermes M, Lappalainen R, Kolehmainen M. The effects of acceptance and commitment therapy on eating behavior and diet delivered through face-to-face contact and a mobile app: a randomized controlled trial. Int J Behav Nutr Phys Act. 2018 Feb 27;15(1):22. doi: 10.1186/s12966-018-0654-8.

    PubMed 29482636

  • Mattila E, Lappalainen R, Valkkynen P, Sairanen E, Lappalainen P, Karhunen L, Peuhkuri K, Korpela R, Kolehmainen M, Ermes M. Usage and Dose Response of a Mobile Acceptance and Commitment Therapy App: Secondary Analysis of the Intervention Arm of a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2016 Jul 28;4(3):e90. doi: 10.2196/mhealth.5241.

    PubMed 27468653

  • Lappalainen R, Sairanen E, Jarvela E, Rantala S, Korpela R, Puttonen S, Kujala UM, Myllymaki T, Peuhkuri K, Mattila E, Kaipainen K, Ahtinen A, Karhunen L, Pihlajamaki J, Jarnefelt H, Laitinen J, Kutinlahti E, Saarelma O, Ermes M, Kolehmainen M. The effectiveness and applicability of different lifestyle interventions for enhancing wellbeing: the study design for a randomized controlled trial for persons with metabolic syndrome risk factors and psychological distress. BMC Public Health. 2014 Apr 4;14:310. doi: 10.1186/1471-2458-14-310.

    PubMed 24708617

Questions about this trial

What is this clinical trial studying?

A study testing Wellbeing intervention (ACT) and Wellbeing intervention (Internet) in people with Metabolic Syndrome Risk Factors and Overweight, run by University of Jyvaskyla at 3 sites in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psychological Flexibility (AAQ-2) (time frame: Change from Baseline in Psychological Flexibility at 8.5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01738256, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2014.

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