Sedentary BehaviorNCT05505864
Assessing Sedentary Behaviour in Adults With Type 2 Diabetes - A Randomized Controlled Trial
A study testing Health Action Process Approach (HAPA) in people with Sedentary Behavior and Diabetes Mellitus, Type 2, run by Western University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedentary Behavior, Diabetes Mellitus, Type 2, Adult ALL
- What is being tested?
- Health Action Process Approach (HAPA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2022to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- any medical or physical limitation that would prevent standing, stretching, and/or light physical activity
Trial locations and contacts
1 site in 1 country.
Siobhan Smith, MA contact
Canada1 site, 1 recruiting
- Recruiting
Harry Prapavessis
London, Ontario
Harry Prapavessis, PhD, 519 661-2111 ext. 80173, hprapave@uwo.ca
About this study
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
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.
Read the 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.
- Conditions
- Sedentary Behavior, Diabetes Mellitus, Type 2, Adult ALL
- Being tested
- Health Action Process Approach (HAPA)
- Medical subject headings
- Sedentary Behavior, Diabetes Mellitus, Type 2, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Action Process Approach (HAPA)Behavioural
Health Action Process Approach (HAPA) using action planning and coping strategies to create health behaviour change
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Health Action Process Approach (HAPA) |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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: 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: Measured at week 12.
Objectively measured total sedentary behaviour
Measured by the ACTIVPAL4
Measured: Measured at week 0.
Objectively measured total sedentary behaviour
Measured by the ACTIVPAL4
Measured: Measured at week 6.
Objectively measured total sedentary behaviour
Measured by the ACTIVPAL4
Measured: Measured at week 12.
Secondary outcomes (31)
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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: Measured at week 12.
Objective sedentary behaviour break frequency
Measured by the ACTIVPAL4
Measured: Measured at week 0.
Objective sedentary behaviour break frequency
Measured by the ACTIVPAL4
Measured: Measured at week 6.
Objective sedentary behaviour break frequency
Measured by the ACTIVPAL4
Measured: Measured at week 12.
Objective sedentary behaviour break duration
Measured by the ACTIVPAL4
Measured: Measured at week 0.
Objective sedentary behaviour break duration
Measured by the ACTIVPAL4
Measured: Measured at week 6.
Objective sedentary behaviour break duration
Measured by the ACTIVPAL4
Measured: 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: 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: 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: Measured at week 12.
Overall experience of the intervention
The intervention group will receive at qualitative interview
Measured: Measured at week 6.
Validate the modified sedentary behaviour questionnaire (SBQ)
The modified sedentary behaviour (SBQ) will be validated with the ACTIVPAL4
Measured: 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: Measured at week 0.
Validate the modified sedentary behaviour questionnaire (SBQ)
The modified sedentary behaviour (SBQ) will be validated with the ACTIVPAL4
Measured: 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: Measured at week 6.
Validate the modified sedentary behaviour questionnaire (SBQ)
The modified sedentary behaviour questionnaire (SBQ) will be validated with the ACTIVPAL4
Measured: 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: Measured at week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start1 Oct 2022
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siobhan Smith, Western University
- Investigators
- Harry Prapavessis, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505864
- Sponsor's protocol ID
- 120585
- Status last verified
- Jan 2023
- First submitted
- 27 Jul 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05505864
- Acronym / sponsor ID
- 120585
- Conditions
- Sedentary Behavior, Diabetes Mellitus, Type 2, Adult ALL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Western UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Health Action Process Approach (HAPA)* 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- any medical or physical limitation that would prevent standing, stretching, and/or light physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Action Process Approach (HAPA)Health Action Process Approach (HAPA) using action planning and coping strategies to create health behaviour change | Behavioural | Intervention Group |
Primary outcome
Self-reported total sedentary behaviour
Time frame: Measured at week 0.
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
Time frame: Measured at week 2.
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
Time frame: Measured at week 4.
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
Time frame: Measured at week 6.
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
Time frame: Measured at week 12.
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
Time frame: Measured at week 0.
Measured by the ACTIVPAL4
Objectively measured total sedentary behaviour
Time frame: Measured at week 6.
Measured by the ACTIVPAL4
Objectively measured total sedentary behaviour
Time frame: Measured at week 12.
Measured by the ACTIVPAL4
31 secondary outcomes
Self-reported sedentary behaviour break frequency
Time frame: Measured at week 0.
Self-reported sedentary behaviour break frequency
Time frame: Measured at week 2.
Self-reported sedentary behaviour break frequency
Time frame: Measured at week 4.
Self-reported sedentary behaviour break frequency
Time frame: Measured at week 6.
Self-reported sedentary behaviour break frequency
Time frame: Measured at week 12.
Self-reported sedentary behaviour break duration
Time frame: Measured at week 0.
Self-reported sedentary behaviour break duration
Time frame: Measured at week 2.
Self-reported sedentary behaviour break duration
Time frame: Measured at week 4.
Self-reported sedentary behaviour break duration
Time frame: Measured at week 6.
Self-reported sedentary behaviour break duration
Time frame: Measured at week 12.
Self-reported screen time
Time frame: Measured at week 0.
Self-reported screen time
Time frame: Measured at week 2.
Self-reported screen time
Time frame: Measured at week 4.
Self-reported screen time
Time frame: Measured at week 6.
Self-reported screen time
Time frame: Measured at week 12.
Objective sedentary behaviour break frequency
Time frame: Measured at week 0.
Objective sedentary behaviour break frequency
Time frame: Measured at week 6.
Objective sedentary behaviour break frequency
Time frame: Measured at week 12.
Objective sedentary behaviour break duration
Time frame: Measured at week 0.
Objective sedentary behaviour break duration
Time frame: Measured at week 6.
Objective sedentary behaviour break duration
Time frame: Measured at week 12.
Self-reported quality of life
Time frame: Measured at week 0.
Self-reported quality of life
Time frame: Measured at week 6.
Self-reported quality of life
Time frame: Measured at week 12.
Overall experience of the intervention
Time frame: Measured at week 6.
Validate the modified sedentary behaviour questionnaire (SBQ)
Time frame: Measured at week 0.
Validate the modified SIT-Q (no unabbreviated name) questionnaire
Time frame: Measured at week 0.
Validate the modified sedentary behaviour questionnaire (SBQ)
Time frame: Measured at week 6.
Validate the modified SIT-Q (no unabbreviated name) questionnaire
Time frame: Measured at week 6.
Validate the modified sedentary behaviour questionnaire (SBQ)
Time frame: Measured at week 12.
Validate the modified SIT-Q (no unabbreviated name) questionnaire
Time frame: Measured at week 12.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: No. No plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siobhan Smith, MA contact
Harry Prapavessis, PhD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Action Process Approach (HAPA) in people with Sedentary Behavior and Diabetes Mellitus, Type 2, run by Western University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harry Prapavessis, PhD (519 661-2111 ext. 80173, hprapave@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported total sedentary behaviour (time frame: Measured at week 0.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.