NCT05115253

Brief Summary

This study will explore the effectiveness of two different interventions, a Health Action Process Approach (HAPA) mobile health (mHealth) intervention and a Just In-Time Adaptive Intervention (JITAI), on reducing sedentary behaviour in office workers. One third of participants will receive the mHealth HAPA intervention, consisting of a theory-driven behavioural counselling session with personalized daily SMS text messages, and another third of participants will receive the JITAI intervention, a behaviour tracking mobile phone application that will alert participants once a set sedentary behaviour condition has been met. The last third of participants will act as a control where they will not receive an intervention or any further information from the letter of information. The study will take place over four weeks, with the first acting as a baseline and the intervention period filling the latter three weeks.

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
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 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

First Submitted

Initial submission to the registry

October 29, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

December 23, 2021

Status Verified

December 1, 2021

Enrollment Period

3 months

First QC Date

October 29, 2021

Last Update Submit

December 7, 2021

Conditions

Keywords

Sedentary BehaviourHealth Behaviour ChangeHAPAHealth Action Process ApproachJITAIJust In-Time Adaptive InterventionOffice Workers

Outcome Measures

Primary Outcomes (5)

  • Changes in Frequency of Breaks from Sitting at Work

    mEMA app (ilumivu Inc., Boston, MA, www.ilumivu.com); accelerometer data Modified version of the SIT-Q 7d (Wijndaele et al., 2014; Sui \& Prapavessis, 2016); 1-item; 12-point scale

    Baseline, Weeks 2, 3, 4

  • Changes in Duration of Breaks from Sitting at Work

    mEMA app (ilumivu Inc., Boston, MA, www.ilumivu.com); accelerometer data Modified version of the SIT-Q 7d (Wijndaele et al., 2014; Sui \& Prapavessis, 2016); 1-item; 10-point scale

    Baseline, Weeks 2, 3, 4

  • Changes in Time Spent Sitting at Work

    mEMA app (ilumivu Inc., Boston, MA, www.ilumivu.com); accelerometer data Modified version of the SIT-Q 7d (Wijndaele et al., 2014; Sui \& Prapavessis, 2016)

    Baseline, Weeks 2, 3, 4

  • Changes in Time Spent Standing at Work

    mEMA app (ilumivu Inc., Boston, MA, www.ilumivu.com); accelerometer data

    Baseline, Weeks 2, 3, 4

  • Changes in Time Spent Engaged in Light Physical Activity at Work

    mEMA app (ilumivu Inc., Boston, MA, www.ilumivu.com); accelerometer data

    Baseline, Weeks 2, 3, 4

Other Outcomes (10)

  • Age

    Baseline

  • Sex

    Baseline

  • Gender

    Baseline

  • +7 more other outcomes

Study Arms (3)

mHealth HAPA Intervention Group

EXPERIMENTAL

This intervention group will receive a single one-on-one online behavioural counselling session and daily personalized SMS text message boosters with the aim of increasing the breaking of consecutive work related sedentary behaviour. Counselling strategies will be grounded in the HAPA model, specifically focusing on the creation of an action plan and the development of coping strategies to increase sedentary behaviour breaks. The SMS text message boosters will be personalized based on participant's preferences of timing, type, frequency, and length. The boosters will framed through HAPA principles with content focusing on risk awareness, outcome expectancy, action and coping planning, barriers and resources, and self-efficacy. The intervention will last for three weeks.

Behavioral: HAPA behavioural counselling + SMS text message boosters

JITAI Group

EXPERIMENTAL

This intervention group will receive push notifications from a EMA behaviour monitoring mobile application that will be downloaded to each participants' mobile phones. The application will measure and monitor a participant's sedentary behaviour and once a pre-set condition of 30 consecutive sedentary minutes has been reached, the application will administer a push notification notifying the participant to break their sedentary behaviour. The push notifications will ask the participants to stand up, stretch, or lightly walk around to break their current behaviour. The intervention will last for three weeks.

Device: JITAI

Control Group

NO INTERVENTION

The control group will receive no intervention or further instruction past the letter of information.

Interventions

Behavioural counseling grounded in the Health Action Process Approach (HAPA; i.e., action planning and coping planning) paired with daily personalized HAPA guided SMS text message boosters to reduce consecutive workplace sedentary behaviour.

mHealth HAPA Intervention Group
JITAIDEVICE

EMA monitoring mobile phone application that uses a phone's on-board accelerometer to monitor a participant's sedentary behaviour and deliver a push notification once a set condition has been met. This intervention will be utilized to reduce consecutive workplace sedentary behaviour.

Also known as: mEMA (ilumivu Inc., Boston, MA, www.ilumivu.com)
JITAI Group

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • full-time employee in a desk-based office job (work from home accepted)
  • have access to a mobile phone with internet connection
  • can read and write in English

You may not qualify if:

  • any medical or physical limitation that would prevent standing, stretching, and/or light physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Western Ontario

London, Ontario, Canada

Location

Study Officials

  • Harry Prapavessis, Ph.D

    Western University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Harry Prapavessis, Ph.D

CONTACT

Brett Carter, B.Sc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Upon obtaining consent, eligible participants will be randomly assigned to either of the two intervention groups, a mHealth HAPA group or a JITAI group, or the control group. The study will run for four weeks with the first week acting as a baseline.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 29, 2021

First Posted

November 10, 2021

Study Start

December 1, 2021

Primary Completion

March 1, 2022

Study Completion

June 1, 2022

Last Updated

December 23, 2021

Record last verified: 2021-12

Locations