Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05115253
Other study ID # 119926
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2021
Est. completion date June 2022

Study information

Verified date December 2021
Source Western University, Canada
Contact Harry Prapavessis, Ph.D
Phone 519 661-2111
Email hparapave@uwo.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This three-arm repeated measure randomized control trial will randomize participants into two intervention groups and one control group to attempt to reduce sedentary behaviour in office workers. The study will last for four weeks, the first week of the study will be used for baseline measurement and the remaining three weeks used for the intervention. Participants will be full time office workers primarily recruited from large businesses and corporations. The primary purpose of the study will be to decrease sedentary behaviour in office workers from pre- to post-intervention by breaking up extended periods of sedentary time. The secondary objectives of the study are to compare the effectiveness of each group against one another to assess for any significant differences in sedentary behaviour profiles, total time spent sitting, break frequency, break duration, and time not spent sedentary as well as to examine whether physical activity changed over the course of the intervention. One intervention group will attempt to reduce sedentary behaviour by receiving push notifications from an EMA tracking mobile phone application after a pre-set sedentary behaviour condition has been met. The application will monitor and collect data from the on-board accelerometer of the participant's phone and when a threshold of 30 consecutive sedentary minutes has been reached, the application will administer a notification asking the participant to break the extended sedentary behaviour they are currently engaged in. The other intervention group will receive a theory-based behaviour change counselling session paired with daily personalized SMS text message boosters to achieve the study's aims. The counselling sessions and SMS text messages will be framed through the Health Action Process Approach, a behaviour change model that centres around action planning and coping planning. The control group will receive no intervention or further information from the letter of information. Sedentary behaviour will be collected in the form of duration of time spent sitting, frequency of sedentary behaviour breaks, and duration of sedentary behaviour breaks. These variables will be measured through an EMA tracking mobile phone application that will be downloaded by each participant as well as a weekly online sedentary behaviour questionnaire. Outcome measures will be compared within and between groups to detect differences.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 93
Est. completion date June 2022
Est. primary completion date March 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 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 Exclusion Criteria: - any medical or physical limitation that would prevent standing, stretching, and/or light physical activity

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
HAPA behavioural counselling + SMS text message boosters
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.
Device:
JITAI
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.

Locations

Country Name City State
Canada The University of Western Ontario London Ontario

Sponsors (1)

Lead Sponsor Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Age Assessed with a single item question: "What is your age?" Baseline
Other Sex Assessed with a single item question: "What is your sex?" Baseline
Other Gender Assessed with a single item question: "What gender do you most identify with?" Baseline
Other Ethnicity Assessed with a single item question: "What ethnicity do you most identify with?" Baseline
Other Height Assessed with a single item question: "What is your height in either inches or centimetres?" Baseline
Other Weight Assessed with a single item question: "What is your weight in either pounds or kilograms?" Baseline
Other Work Environment Assessed with a three item question: "What is your current work environment?"; in office, at home, hybrid Baseline
Other Type of Occupation Assessed with a four item question: "What general sector does your occupation fall under?"; private, public, charity, other Baseline
Other Hours of Work per Week Assessed with a single item question: "What are your typical hours of work on an average week?" Baseline
Other Education Level Assessed with a single item question: "What is your current formal education level?" Baseline
Primary 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
Primary 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
Primary 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
Primary Changes in Time Spent Standing at Work mEMA app (ilumivu Inc., Boston, MA, www.ilumivu.com); accelerometer data Baseline, Weeks 2, 3, 4
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT02913079 - The Acute Impact of Sit-stand Desks on Post-meal Blood Sugar Levels N/A
Completed NCT02911649 - Reducing Sedentary Behaviour With Technology N/A
Active, not recruiting NCT05678985 - Evaluating Impact and Implementation of Choose to Move (Phase 4) N/A
Completed NCT03612882 - Sedentary Behaviour and Subjective Well-being
Recruiting NCT06124248 - Effectiveness of the RISE Intervention N/A
Completed NCT03505385 - Effects of a Unique Co-created Intervention With Care Home Residents and University Students Following a Service-learning Methodology to Reduce Sedentary Behaviour. N/A
Not yet recruiting NCT06247228 - Click2Move Intervention to Reduce Home-office Workers' Sedentary Behaviour. N/A
Completed NCT06106464 - Cardiometabolic Effects of Aerobic Exercise Plus Breaking Sitting N/A
Completed NCT02629666 - Exercise Referral Schemes Enhanced by Self-Management Strategies to Battle Sedentary Behaviour N/A
Completed NCT00281385 - Health and Psychological Outcomes of Lifestyle Versus Traditional Physical Activity Phase 1/Phase 2