NCT05216159

Brief Summary

This study will explore the effectiveness of a Health Action Process Approach (HAPA) mobile health (mHealth) intervention on reducing sedentary behaviour and perceived stress in desk-based office workers. Half of participants will receive a mHealth HAPA intervention consisting of a theory-driven behavioural counselling session and weekly HAPA based worksheets delivered through a mobile application. The other half of participants will act as a control group and will receive no intervention or information past the letter of information. The study will take place over eight weeks, with the first four weeks acting as the intervention period and a follow-up at the end of week eight.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 17, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 8, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

January 17, 2022

Last Update Submit

February 29, 2024

Conditions

Keywords

Sedentary BehaviourHealth Behaviour ChangePerceived StressHealth Action Process ApproachOffice WorkersmHealthMobile Health

Outcome Measures

Primary Outcomes (5)

  • Changes in Time Spent Sitting at Work

    modified Occupational Physical Activity Questionnaire (Reis et al., 2005; Chau et al., 2012); 5-items

    Baseline, Weeks 1, 2, 3, 4, 8

  • Changes in Time Spent Standing at Work

    modified Occupational Physical Activity Questionnaire (Reis et al., 2005; Chau et al., 2012); 5-items

    Baseline, Weeks 1, 2, 3, 4, 8

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

    modified Occupational Physical Activity Questionnaire (Reis et al., 2005; Chau et al., 2012); 5-items

    Baseline, Weeks 1, 2, 3, 4, 8

  • Changes in Frequency of Breaks from Sitting at Work

    Modified version of the Last 7-day Sedentary Behaviour Questionnaire (SIT-Q 7d) (Wijndaele et al., 2014; Sui \& Prapavessis, 2016); 1-item; 12-point scale (Less than every 30 min, Every 30-45 min, Every 45 min-1 hour, Every 1-1.5 hours, Every 1.5-2 hours, Every 2-3 hours, Every 3-4 hours, Every 4-5 hours, Over every 5 hours, No interruption); Lower values represent a better outcome

    Baseline, Weeks 1, 2, 3, 4, 8

  • Changes in Duration of Breaks from Sitting at Work

    Modified version of the Last 7-day Sedentary Behaviour Questionnaire (SIT-Q 7d) (Wijndaele et al., 2014; Sui \& Prapavessis, 2016); 1-item; 10-point scale (Less than 30 sec, 30 sec-1 min, 1-2 min, 2-3 min, 3-4 min, 4-5 min, 5-10 min, 10-15 min, 15-30 min, Over 30 min); Higher values represent a better outcome

    Baseline, Weeks 1, 2, 3, 4, 8

Secondary Outcomes (1)

  • Changes in Perceived Stress

    Baseline, Week 4

Other Outcomes (8)

  • Age

    Baseline

  • Sex

    Baseline

  • Gender

    Baseline

  • +5 more other outcomes

Study Arms (2)

mHealth HAPA Intervention Group

EXPERIMENTAL

This intervention group will receive a single one-on-one behavioural counselling session and weekly action and coping planning worksheets delivered through a downloaded smartphone application 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 action plans and the development of coping strategies to increase sedentary behaviour breaks. The weekly HAPA based worksheets will be sent out to participants at the beginning of their work week so that they can formulate their own personal action plans and coping strategies for the week to come. They will be prompted to refer back to the information conveyed in one-on-one counselling session where they should try to create action plans that are specific and meaningful to them. The intervention will last for a total of four weeks with the outcomes being measured through questionnaires.

Behavioral: HAPA behavioural counselling + weekly HAPA worksheets

Control Group

NO INTERVENTION

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

Interventions

Behavioural counselling grounded in the Health Action Process Approach (HAPA; ie., action planning and coping planning) paired with weekly HAPA based worksheets delivered through a mobile application, SEMA3, to reduce consecutive workplace sedentary behaviour.

mHealth HAPA Intervention 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 smartphone 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

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Harry Prapavessis, Ph.D

    Western University

    PRINCIPAL INVESTIGATOR

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 the intervention group or the control group. The study will run for eight weeks, with a four week intervention period and a follow-up at the end of week eight.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 17, 2022

First Posted

January 31, 2022

Study Start

March 8, 2022

Primary Completion

July 30, 2022

Study Completion

July 31, 2022

Last Updated

March 1, 2024

Record last verified: 2024-02

Locations