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

Primary Purpose

Sedentary Behavior, Diabetes Mellitus, Type 2, Adult ALL

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Health Action Process Approach (HAPA)
Sponsored by
Western University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sedentary Behavior

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Harry PrapavessisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
Objectively measured total sedentary behaviour
Measured by the ACTIVPAL4
Objectively measured total sedentary behaviour
Measured by the ACTIVPAL4
Objectively measured total sedentary behaviour
Measured by the ACTIVPAL4

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Objective sedentary behaviour break frequency
Measured by the ACTIVPAL4
Objective sedentary behaviour break frequency
Measured by the ACTIVPAL4
Objective sedentary behaviour break frequency
Measured by the ACTIVPAL4
Objective sedentary behaviour break duration
Measured by the ACTIVPAL4
Objective sedentary behaviour break duration
Measured by the ACTIVPAL4
Objective sedentary behaviour break duration
Measured by the ACTIVPAL4
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).
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).
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).
Overall experience of the intervention
The intervention group will receive at qualitative interview
Validate the modified sedentary behaviour questionnaire (SBQ)
The modified sedentary behaviour (SBQ) will be validated with the ACTIVPAL4
Validate the modified SIT-Q (no unabbreviated name) questionnaire
The modified SIT-Q (no unabbreviated name) questionnaires will be validated with the ACTIVPAL4
Validate the modified sedentary behaviour questionnaire (SBQ)
The modified sedentary behaviour (SBQ) will be validated with the ACTIVPAL4
Validate the modified SIT-Q (no unabbreviated name) questionnaire
The modified SIT-Q (no unabbreviated name) questionnaire will be validated with the ACTIVPAL4
Validate the modified sedentary behaviour questionnaire (SBQ)
The modified sedentary behaviour questionnaire (SBQ) will be validated with the ACTIVPAL4
Validate the modified SIT-Q (no unabbreviated name) questionnaire
The modified SIT-Q (no unabbreviated name) questionnaires will be validated with the ACTIVPAL4

Full Information

First Posted
July 27, 2022
Last Updated
January 13, 2023
Sponsor
Western University
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1. Study Identification

Unique Protocol Identification Number
NCT05505864
Brief Title
Assessing Sedentary Behaviour in Adults With Type 2 Diabetes - A Randomized Controlled 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedentary Behavior, Diabetes Mellitus, Type 2, Adult ALL

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Action Process Approach (HAPA)
Intervention Description
Health Action Process Approach (HAPA) using action planning and coping strategies to create health behaviour change
Primary Outcome Measure Information:
Title
Self-reported total sedentary behaviour
Description
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.
Time Frame
Measured at week 0.
Title
Self-reported total sedentary behaviour
Description
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.
Time Frame
Measured at week 2.
Title
Self-reported total sedentary behaviour
Description
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.
Time Frame
Measured at week 4.
Title
Self-reported total sedentary behaviour
Description
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.
Time Frame
Measured at week 6.
Title
Self-reported total sedentary behaviour
Description
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.
Time Frame
Measured at week 12.
Title
Objectively measured total sedentary behaviour
Description
Measured by the ACTIVPAL4
Time Frame
Measured at week 0.
Title
Objectively measured total sedentary behaviour
Description
Measured by the ACTIVPAL4
Time Frame
Measured at week 6.
Title
Objectively measured total sedentary behaviour
Description
Measured by the ACTIVPAL4
Time Frame
Measured at week 12.
Secondary Outcome Measure Information:
Title
Self-reported sedentary behaviour break frequency
Description
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.
Time Frame
Measured at week 0.
Title
Self-reported sedentary behaviour break frequency
Description
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.
Time Frame
Measured at week 2.
Title
Self-reported sedentary behaviour break frequency
Description
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.
Time Frame
Measured at week 4.
Title
Self-reported sedentary behaviour break frequency
Description
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.
Time Frame
Measured at week 6.
Title
Self-reported sedentary behaviour break frequency
Description
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.
Time Frame
Measured at week 12.
Title
Self-reported sedentary behaviour break duration
Description
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.
Time Frame
Measured at week 0.
Title
Self-reported sedentary behaviour break duration
Description
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.
Time Frame
Measured at week 2.
Title
Self-reported sedentary behaviour break duration
Description
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.
Time Frame
Measured at week 4.
Title
Self-reported sedentary behaviour break duration
Description
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.
Time Frame
Measured at week 6.
Title
Self-reported sedentary behaviour break duration
Description
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.
Time Frame
Measured at week 12.
Title
Self-reported screen time
Description
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.
Time Frame
Measured at week 0.
Title
Self-reported screen time
Description
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.
Time Frame
Measured at week 2.
Title
Self-reported screen time
Description
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.
Time Frame
Measured at week 4.
Title
Self-reported screen time
Description
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.
Time Frame
Measured at week 6.
Title
Self-reported screen time
Description
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.
Time Frame
Measured at week 12.
Title
Objective sedentary behaviour break frequency
Description
Measured by the ACTIVPAL4
Time Frame
Measured at week 0.
Title
Objective sedentary behaviour break frequency
Description
Measured by the ACTIVPAL4
Time Frame
Measured at week 6.
Title
Objective sedentary behaviour break frequency
Description
Measured by the ACTIVPAL4
Time Frame
Measured at week 12.
Title
Objective sedentary behaviour break duration
Description
Measured by the ACTIVPAL4
Time Frame
Measured at week 0.
Title
Objective sedentary behaviour break duration
Description
Measured by the ACTIVPAL4
Time Frame
Measured at week 6.
Title
Objective sedentary behaviour break duration
Description
Measured by the ACTIVPAL4
Time Frame
Measured at week 12.
Title
Self-reported quality of life
Description
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).
Time Frame
Measured at week 0.
Title
Self-reported quality of life
Description
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).
Time Frame
Measured at week 6.
Title
Self-reported quality of life
Description
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).
Time Frame
Measured at week 12.
Title
Overall experience of the intervention
Description
The intervention group will receive at qualitative interview
Time Frame
Measured at week 6.
Title
Validate the modified sedentary behaviour questionnaire (SBQ)
Description
The modified sedentary behaviour (SBQ) will be validated with the ACTIVPAL4
Time Frame
Measured at week 0.
Title
Validate the modified SIT-Q (no unabbreviated name) questionnaire
Description
The modified SIT-Q (no unabbreviated name) questionnaires will be validated with the ACTIVPAL4
Time Frame
Measured at week 0.
Title
Validate the modified sedentary behaviour questionnaire (SBQ)
Description
The modified sedentary behaviour (SBQ) will be validated with the ACTIVPAL4
Time Frame
Measured at week 6.
Title
Validate the modified SIT-Q (no unabbreviated name) questionnaire
Description
The modified SIT-Q (no unabbreviated name) questionnaire will be validated with the ACTIVPAL4
Time Frame
Measured at week 6.
Title
Validate the modified sedentary behaviour questionnaire (SBQ)
Description
The modified sedentary behaviour questionnaire (SBQ) will be validated with the ACTIVPAL4
Time Frame
Measured at week 12.
Title
Validate the modified SIT-Q (no unabbreviated name) questionnaire
Description
The modified SIT-Q (no unabbreviated name) questionnaires will be validated with the ACTIVPAL4
Time Frame
Measured at week 12.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Harry Prapavessis, PhD
Phone
519 661-2111
Ext
80173
Email
hprapave@uwo.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Siobhan Smith, MA
Email
ssmit422@uwo.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry Prapavessis, PhD
Organizational Affiliation
Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harry Prapavessis
City
London
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harry Prapavessis, PhD
Phone
519 661-2111
Ext
80173
Email
hprapave@uwo.ca

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to make individual participant data available to other researchers.

Learn more about this trial

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

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