Assessing Sedentary Behaviour in Adults With Type 2 Diabetes - A Randomized Controlled Trial
A Combined Health Action Process Approach and mHealth Intervention to Assess Sedentary Behaviour in Adults With Type 2 Diabetes - A Randomized Controlled Trial
1 other identifier
interventional
52
1 country
1
Brief Summary
The purpose of this health behaviour change research study is to assist adults with T2D in achieving the Canadian 24-hour sedentary behaviour movement guidelines.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2022
CompletedFirst Posted
Study publicly available on registry
August 18, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedJanuary 18, 2023
January 1, 2023
11 months
July 27, 2022
January 13, 2023
Conditions
Outcome Measures
Primary Outcomes (8)
Self-reported total sedentary behaviour
Measured by the modified sedentary behaviour questionnaire (SBQ). Where total daily sedentary behaviour ranges from 0 to 24 hours. Higher number of hours is worse.
Measured at week 0.
Self-reported total sedentary behaviour
Measured by the modified sedentary behaviour questionnaire (SBQ). Where total daily sedentary behaviour ranges from 0 to 24 hours. Higher number of hours is worse.
Measured at week 2.
Self-reported total sedentary behaviour
Measured by the modified sedentary behaviour questionnaire (SBQ). Where total daily sedentary behaviour ranges from 0 to 24 hours. Higher number of hours is worse.
Measured at week 4.
Self-reported total sedentary behaviour
Measured by the modified sedentary behaviour questionnaire (SBQ). Where total daily sedentary behaviour ranges from 0 to 24 hours. Higher number of hours is worse.
Measured at week 6.
Self-reported total sedentary behaviour
Measured by the modified sedentary behaviour questionnaire (SBQ). Where total daily sedentary behaviour ranges from 0 to 24 hours. Higher number of hours is worse.
Measured at week 12.
Objectively measured total sedentary behaviour
Measured by the ACTIVPAL4
Measured at week 0.
Objectively measured total sedentary behaviour
Measured by the ACTIVPAL4
Measured at week 6.
Objectively measured total sedentary behaviour
Measured by the ACTIVPAL4
Measured at week 12.
Secondary Outcomes (31)
Self-reported sedentary behaviour break frequency
Measured at week 0.
Self-reported sedentary behaviour break frequency
Measured at week 2.
Self-reported sedentary behaviour break frequency
Measured at week 4.
Self-reported sedentary behaviour break frequency
Measured at week 6.
Self-reported sedentary behaviour break frequency
Measured at week 12.
- +26 more secondary outcomes
Study Arms (2)
Intervention Group
EXPERIMENTAL* Participants in the intervention group will be asked to wear an ACTIVPAL4 at week 0, 5, and 11. * Participants in the intervention group will be asked to fill out questionnaires assessing key variable (demographics, sedentary behaviour, and quality of life) on the SEMA3 app at week 0, 2, 4, 6, and 12. * Participants in the intervention group will receive a one-on-one behavioural counselling session online through zoom at week 0 to create personalized action plans and coping strategies to reduce and break up sedentary behaviour. The participant will update these action plans and coping strategies at the end of week 2 and 4 on the SEMA3 app. * Participants in the intervention group will receive tailored text messages the day after receiving their one-on-one counselling session for a 6-week period. * Participants in the intervention will receive one-on-one qualitative interview on zoom at week 6 to explore participants overall experience engaging in the intervention.
Control Group
NO INTERVENTION* Participants in the control group will be asked to wear an ACTIVPAL4 at week 0, 5, and 11. * Participants in the control group will be asked to fill out questionnaires assessing key variable (demographics, sedentary behaviour, and quality of life) on the SEMA3 mobile app at week 0, 2, 4, 6, and 12.
Interventions
Health Action Process Approach (HAPA) using action planning and coping strategies to create health behaviour change
Eligibility Criteria
You may qualify if:
- years or older
- diagnosed with type 2 diabetes
- access to a smart phone with internet connection
- be able to read, write, and speak 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)
Harry Prapavessis
London, Ontario, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harry Prapavessis, PhD
Western University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Harry Prapavessis, Principal Investigator
Study Record Dates
First Submitted
July 27, 2022
First Posted
August 18, 2022
Study Start
October 1, 2022
Primary Completion
September 1, 2023
Study Completion
September 1, 2023
Last Updated
January 18, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share
No plan to make individual participant data available to other researchers.