Assessing Sedentary Behaviour in Adults With Type 2 Diabetes - A Randomized Controlled Trial

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Combined Health Action Process Approach and mHealth Intervention to Assess Sedentary Behaviour in Adults With Type 2 Diabetes - A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05505864
• Other study ID #: 120585
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: September 2023

Study information

• Verified date: January 2023
• Source: Western University
• Contact: Harry Prapavessis, PhD
• Phone: 519 661-2111
• Email: hprapave[@]uwo.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Adults with type 2 diabetes (T2D) are less active and accumulate more sedentary behaviour (SB) than those without. Among adults with T2D, increased SB is associated with increased mortality after adjusting for physical activity. Canadian 24-hour SB movement guidelines recommend limiting SB to ≤8 hours, no more than 3 hours of recreational screen time, and breaking up long periods of SB as often as possible. Therefore, the purpose of this research study is for adults with T2D to achieve these SB Canadian 24-hour SB movement guidelines. To address this purpose, we will be conducting a six-week two-arm repeated measures randomized control trial. The intervention group will receive a theory-based behaviour change counselling session through zoom at week 0, mobile phone application at weeks 2 and 4 that encourage participants to create their own personal and specific action plans and coping strategies, and daily text messages that motivate participants to reduce and break up their SB. The control group will receive no intervention. The primary objective of the study is to reduce SB, while the secondary objectives are to break up SB, reduce screen time, improve quality of life, determine the perceptions towards the intervention, and validate the SB questionnaires. SB will be collected in the form of total daily SB, frequency of SB breaks, and duration of SB breaks. These variables will be measured through a SB and quality of life questionnaires that will be delivered through a downloadable mobile phone application. Outcome measures will be compared within and between groups to detect differences.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Adult ALL
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Sedentary Behavior

Intervention

Behavioral:
• Health Action Process Approach (HAPA)
Health Action Process Approach (HAPA) using action planning and coping strategies to create health behaviour change

Locations

Country	Name	City	State
Canada	Harry Prapavessis	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	Objectively measured total sedentary behaviour	Measured by the ACTIVPAL4	Measured at week 0.
Primary	Objectively measured total sedentary behaviour	Measured by the ACTIVPAL4	Measured at week 6.
Primary	Objectively measured total sedentary behaviour	Measured by the ACTIVPAL4	Measured at week 12.
Secondary	Self-reported sedentary behaviour break frequency	Measured by the modified SIT-Q (no unabbreviated name) questionnaire. Where break frequency ranges from "less than every 30 minutes" to "over every 7 hours". Less frequent breaks is worse.	Measured at week 0.
Secondary	Self-reported sedentary behaviour break frequency	Measured by the modified SIT-Q (no unabbreviated name) questionnaire. Where break frequency ranges from "less than every 30 minutes" to "over every 7 hours". Less frequent breaks is worse.	Measured at week 2.
Secondary	Self-reported sedentary behaviour break frequency	Measured by the modified SIT-Q (no unabbreviated name) questionnaire. Where break frequency ranges from "less than every 30 minutes" to "over every 7 hours". Less frequent breaks is worse.	Measured at week 4.
Secondary	Self-reported sedentary behaviour break frequency	Measured by the modified SIT-Q (no unabbreviated name) questionnaire. Where break frequency ranges from "less than every 30 minutes" to "over every 7 hours". Less frequent breaks is worse.	Measured at week 6.
Secondary	Self-reported sedentary behaviour break frequency	Measured by the modified SIT-Q (no unabbreviated name) questionnaire. Where break frequency ranges from "less than every 30 minutes" to "over every 7 hours". Less frequent breaks is worse.	Measured at week 12.
Secondary	Self-reported sedentary behaviour break duration	Measured by the modified SIT-Q (no unabbreviated name) questionnaire. Where break duration ranges from "less than 30 seconds" to "over every 30 minutes". Shorter breaks are worse.	Measured at week 0.
Secondary	Self-reported sedentary behaviour break duration	Measured by the modified SIT-Q (no unabbreviated name) questionnaire. Where break duration ranges from "less than 30 seconds" to "over every 30 minutes". Shorter breaks are worse.	Measured at week 2.
Secondary	Self-reported sedentary behaviour break duration	Measured by the modified SIT-Q (no unabbreviated name) questionnaire. Where break duration ranges from "less than 30 seconds" to "over every 30 minutes". Shorter breaks are worse.	Measured at week 4.
Secondary	Self-reported sedentary behaviour break duration	Measured by the modified SIT-Q (no unabbreviated name) questionnaire. Where break duration ranges from "less than 30 seconds" to "over every 30 minutes". Shorter breaks are worse.	Measured at week 6.
Secondary	Self-reported sedentary behaviour break duration	Measured by the modified SIT-Q (no unabbreviated name) questionnaire. Where break duration ranges from "less than 30 seconds" to "over every 30 minutes". Shorter breaks are worse.	Measured at week 12.
Secondary	Self-reported screen time	Measured by a domain of the modified sedentary behaviour questionnaire (SBQ). Where total daily screen time ranges from 0 to 18 hours. Higher number of hours is worse.	Measured at week 0.
Secondary	Self-reported screen time	Measured by a domain of the modified sedentary behaviour questionnaire (SBQ). Where total daily screen time ranges from 0 to 18 hours. Higher number of hours is worse.	Measured at week 2.
Secondary	Self-reported screen time	Measured by a domain of the modified sedentary behaviour questionnaire (SBQ). Where total daily screen time ranges from 0 to 18 hours. Higher number of hours is worse.	Measured at week 4.
Secondary	Self-reported screen time	Measured by a domain of the modified sedentary behaviour questionnaire (SBQ). Where total daily screen time ranges from 0 to 18 hours. Higher number of hours is worse.	Measured at week 6.
Secondary	Self-reported screen time	Measured by a domain of the modified sedentary behaviour questionnaire (SBQ). Where total daily screen time ranges from 0 to 18 hours. Higher number of hours is worse.	Measured at week 12.
Secondary	Objective sedentary behaviour break frequency	Measured by the ACTIVPAL4	Measured at week 0.
Secondary	Objective sedentary behaviour break frequency	Measured by the ACTIVPAL4	Measured at week 6.
Secondary	Objective sedentary behaviour break frequency	Measured by the ACTIVPAL4	Measured at week 12.
Secondary	Objective sedentary behaviour break duration	Measured by the ACTIVPAL4	Measured at week 0.
Secondary	Objective sedentary behaviour break duration	Measured by the ACTIVPAL4	Measured at week 6.
Secondary	Objective sedentary behaviour break duration	Measured by the ACTIVPAL4	Measured at week 12.
Secondary	Self-reported quality of life	Measured by the modified short form -36 (SF-36) questionnaire. This questionnaire will use sub-scales: role limitations due to physical health (4 yes/ no questions), role limitations due to emotional problems (6 yes/no questions), energy, fatigue, and emotional well-being (9 six-point scale questions).	Measured at week 0.
Secondary	Self-reported quality of life	Measured by the modified short form -36 (SF-36) questionnaire. This questionnaire will use sub-scales: role limitations due to physical health (4 yes/ no questions), role limitations due to emotional problems (6 yes/no questions), energy, fatigue, and emotional well-being (9 six-point scale questions).	Measured at week 6.
Secondary	Self-reported quality of life	Measured by the modified short form -36 (SF-36) questionnaire. This questionnaire will use sub-scales: role limitations due to physical health (4 yes/ no questions), role limitations due to emotional problems (6 yes/no questions), energy, fatigue, and emotional well-being (9 six-point scale questions).	Measured at week 12.
Secondary	Overall experience of the intervention	The intervention group will receive at qualitative interview	Measured at week 6.
Secondary	Validate the modified sedentary behaviour questionnaire (SBQ)	The modified sedentary behaviour (SBQ) will be validated with the ACTIVPAL4	Measured at week 0.
Secondary	Validate the modified SIT-Q (no unabbreviated name) questionnaire	The modified SIT-Q (no unabbreviated name) questionnaires will be validated with the ACTIVPAL4	Measured at week 0.
Secondary	Validate the modified sedentary behaviour questionnaire (SBQ)	The modified sedentary behaviour (SBQ) will be validated with the ACTIVPAL4	Measured at week 6.
Secondary	Validate the modified SIT-Q (no unabbreviated name) questionnaire	The modified SIT-Q (no unabbreviated name) questionnaire will be validated with the ACTIVPAL4	Measured at week 6.
Secondary	Validate the modified sedentary behaviour questionnaire (SBQ)	The modified sedentary behaviour questionnaire (SBQ) will be validated with the ACTIVPAL4	Measured at week 12.
Secondary	Validate the modified SIT-Q (no unabbreviated name) questionnaire	The modified SIT-Q (no unabbreviated name) questionnaires will be validated with the ACTIVPAL4	Measured at week 12.