NCT03854877

Brief Summary

The main aim of the study is to test effectiveness of a multiple intervention program aimed at making positive changes to health behaviour and stress. Effectiveness of a 4 month workplace intervention, with virtual coaching and co-worker-support, will be assessed as changes in subjective and objective measures of stress, work ability, recovery and health behaviour.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2017

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

February 26, 2019

Status Verified

August 1, 2018

Enrollment Period

3 years

First QC Date

September 14, 2017

Last Update Submit

February 25, 2019

Conditions

Keywords

Health behaviourWork place interventionStressPhysical activityNutritione-healthMindfulness

Outcome Measures

Primary Outcomes (2)

  • Allostatic load (AL)

    Allostatic load (AL) (allostatic load and allostatic overload refers to the cumulative result of an allostatic state) is measured by the following primary and secondary markers: salivary cortisol (µg/dl) heart rate variability measurement \[RMSSD, (ms)\], (hsCRP (mg/l), HbA1c (mmol/mol), triglycerides (mmol/l). Salivary cortisol is the mean of morning and evening samples (Aardal, E.\&Holm, A. 1995), (RMSSD is the value on recovery during sleeping (First\_beat Manual 2014). Clinical cutoff values are used for salivary cortisol, hsCRP, HbA1c and triglycerides and age-reference value (HUSLAB Manual 2018). All markers are dichotomized (0 = below the clinical or age-reference; 1= exceeds the clinical or age-reference). Total Allostatic load is calculated as the sum of all measures (range 0 to 5) (Altman et. al.1986). Total Allostatic load we shown before and after the intervention.

    Change from baseline in stress after four months

  • Perceived stress

    General Health Questionnaire (GHQ-12). The scale includes 12 items. The four response choices (0 "Not at all", 1 "Same as usual", 2 "Rather more than usual" and 3 "Much more than usual") will be dichotomized as follows: 1=0, 2=1, 3=2, 4=3. GHQ-12 case ≥ 3 points (range 0-36). The higher values indicate higher psychological symptoms. The reference mean value is 10.3 (SD 5.0) points (Holi, Marttunen, Aalberg 2003).

    Change from baseline in stress after four months

Secondary Outcomes (8)

  • Economic benefits

    Sickness absence absence [ (Time Frame: approx. 3 years (from 2016 to 2019) ]

  • Intuitive eating

    Change from baseline after four months

  • Eating habits

    Change from baseline after four months.

  • Measured physical activity

    Change from baseline after four months

  • Work ability

    Change from baseline after four months

  • +3 more secondary outcomes

Study Arms (2)

Health behaviour intervention

EXPERIMENTAL

Personalised health behaviour e-health intervention. The intervention uses the principles of acceptance-commitment therapy (ACT). It aims to promote health habits. Based on personal needs participants can choose tasks for physical activity, relaxation, healthy eating, sleep etc. They get regular feedback, tasks and support from their personal trainer via phone and computer.

Behavioral: Health behaviour intervention

Control group

NO INTERVENTION

Only before and after measurements

Interventions

The intervention uses the principles of acceptance-commitment therapy (ACT). It aims to increase healthy eating and good sleep. Based on personal needs participants can choose task for physical activity, relaxation, healthy eating, sleep eg. Their get regular feedback and support from their personal trainer via phone and computer.

Health behaviour intervention

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntary
  • Working in municipal city of Espoo or Kouvola in preschool

You may not qualify if:

  • Pregnancy
  • Retirement during the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Finnish Institute of Occupational Health

Helsinki, Uusimaa, 00250, Finland

Location

Related Publications (1)

  • Karihtala T, Puttonen S, Valtonen AM, Kautiainen H, Hopsu L, Heinonen A. Role of physical activity in the relationship between recovery from work and insomnia among early childhood education and care professionals: a cross-sectional study. BMJ Open. 2024 Mar 19;14(3):e079746. doi: 10.1136/bmjopen-2023-079746.

MeSH Terms

Conditions

Health BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Sampsa Puttonen, PhD

    Finnish Institute of Occupational Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster randomized two group behavioral intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2017

First Posted

February 26, 2019

Study Start

February 15, 2017

Primary Completion

February 28, 2020

Study Completion

February 28, 2020

Last Updated

February 26, 2019

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations