NCT01738256

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
339

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 30, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 10, 2014

Status Verified

February 1, 2014

Enrollment Period

1.3 years

First QC Date

August 17, 2012

Last Update Submit

February 7, 2014

Conditions

Metabolic Syndrome Risk FactorsOverweightPsychological Stress

Keywords

Cognitive Behavior TherapyAcceptance Commitment TherapyPsychological StressMetabolic SyndromeOverweightLife Style

Outcome Measures

Primary Outcomes (1)

  • Psychological Flexibility (AAQ-2)

    Change from Baseline in Psychological Flexibility at 8.5 months

Secondary Outcomes (7)

  • Diet (interview, questionnaire)

    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)

  • Blood lipids

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

  • Sleep (ESS, Basic Nordic Sleep Questionnaire, actigraphy, sleep diary)

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

  • Physical Activity (questionnaire)

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

  • +2 more secondary outcomes

Study Arms (4)

Face-to-Face

EXPERIMENTAL

Group meetings face-to-face using intervention for wellbeing with ACT principles.

Behavioral: Wellbeing intervention (ACT)

Mobile

EXPERIMENTAL

Intervention for wellbeing via mobile phone application with ACT principles.

Behavioral: Wellbeing intervention (ACT)

Internet

EXPERIMENTAL

Intervention for wellbeing via Internet (Virtual Health Check and Coaching).

Behavioral: Wellbeing intervention (Internet)

Control

EXPERIMENTAL

Control group, no intervention.

Behavioral: No intervention

Interventions

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.

Face-to-FaceMobile
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).

Internet
No interventionBEHAVIORAL

No intervention

Control

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Institute of Biomedicine, University of Helsinki

Helsinki, 00290, Finland

Location

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

Jyväskylä, 40014, Finland

Location

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

Kuopio, 80101, Finland

Location

Related Publications (6)

  • 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.

    PMID: 38375882DERIVED

  • 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.

    PMID: 34183032DERIVED

  • 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.

    PMID: 32394219DERIVED

  • 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.

    PMID: 29482636DERIVED

  • 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.

    PMID: 27468653DERIVED

  • 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.

    PMID: 24708617DERIVED

MeSH Terms

Conditions

OverweightStress, PsychologicalMetabolic Syndrome

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Raimo Lappalainen, PhD

    University of Jyvaskyla

    PRINCIPAL INVESTIGATOR

  • Marjukka Kolehmainen, PhD

    University of Eastern Finland

    PRINCIPAL INVESTIGATOR

  • Miikka Ermes, PhD

    VTT Technical Research Centre of Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2012

First Posted

November 30, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 10, 2014

Record last verified: 2014-02

Locations

FI(3)