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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05216159
Other study ID # 120488
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 8, 2022
Est. completion date July 31, 2022

Study information

Verified date February 2024
Source Western University, Canada
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This two-arm, repeated measure randomized control trial will randomize participants into two groups, an intervention group and a no-contact control group in an attempt to reduce sedentary behaviour in desk-based office workers. The study will last for eight weeks, comprising of a four week intervention period and a follow-up at week eight. Participants will be full time desk-based office workers primarily recruited from large businesses and corporations. The primary objective of the study is to reduce sedentary behaviour, while the secondary objective is to determine if a theory-based behaviour change intervention tailored to workplace sedentary would affect general stress levels of desk-based office workers over the course of the intervention. The intervention group will receive an initial theory-based behaviour change counselling session through video chat and then continued through a mobile application where weekly worksheets will be delivered to a participant's mobile phone and encourage the participant to create their own personal and specific action plans and coping strategies. The control group will receive no intervention or further instruction past 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 a sedentary behaviour and perceived stress questionnaires that will be delivered through a downloadable mobile phone application. Outcome measures will be compared within and between groups to detect differences. Participants will be recruited through emails to relevant liaisons and senior executives as well as through emails directly to office working employees in the London area.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date July 31, 2022
Est. primary completion date July 30, 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 smartphone 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


Intervention

Behavioral:
HAPA behavioural counselling + weekly HAPA worksheets
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.

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 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 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
Primary 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
Primary 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
Primary 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
Primary 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 Changes in Perceived Stress Perceived Stress Scale (PSS) (Cohen, Kamarck & Mermelstein, 1983); 10-item; 5-point scale (Never, Almost NEver, Sometimes, Fairly Often, Very Often); Lower values represent a better outcome Baseline, Week 4
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