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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Sedentary Behavior; Adult ALL
• Intervention / Treatment: Behavioral: Health Action Process Approach (HAPA)

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Harry Prapavessis, PhD; Phone Number: 80173 519 661-2111; Email: hprapave@uwo.ca
• Study Contact Backup: Name: Siobhan Smith, MA; Email: ssmit422@uwo.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada
      • Recruiting
      • Harry Prapavessis
      • Contact: Harry Prapavessis, PhD; Phone Number: 80173 519 661-2111; Email: hprapave@uwo.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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.	Behavioral: Health Action Process Approach (HAPA); Health Action Process Approach (HAPA) using action planning and coping strategies to create health behaviour change
No Intervention: Control Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Objective sedentary behaviour break frequency	Measured by the ACTIVPAL4	Measured at week 0.
Objective sedentary behaviour break frequency	Measured by the ACTIVPAL4	Measured at week 6.
Objective sedentary behaviour break frequency	Measured by the ACTIVPAL4	Measured at week 12.
Objective sedentary behaviour break duration	Measured by the ACTIVPAL4	Measured at week 0.
Objective sedentary behaviour break duration	Measured by the ACTIVPAL4	Measured at week 6.
Objective sedentary behaviour break duration	Measured by the ACTIVPAL4	Measured at week 12.
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.
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.
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.
Overall experience of the intervention	The intervention group will receive at qualitative interview	Measured at week 6.
Validate the modified sedentary behaviour questionnaire (SBQ)	The modified sedentary behaviour (SBQ) will be validated with the ACTIVPAL4	Measured at week 0.
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.
Validate the modified sedentary behaviour questionnaire (SBQ)	The modified sedentary behaviour (SBQ) will be validated with the ACTIVPAL4	Measured at week 6.
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.
Validate the modified sedentary behaviour questionnaire (SBQ)	The modified sedentary behaviour questionnaire (SBQ) will be validated with the ACTIVPAL4	Measured at week 12.
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.

Collaborators and Investigators

• Sponsor: Western University
• Investigators: Principal Investigator: Harry Prapavessis, PhD, Western University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (Actual): August 18, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 120585

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No