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

January 13, 2023 updated by: Siobhan Smith, Western University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Harry Prapavessis, PhD
  • Phone Number: 80173 519 661-2111
  • Email: hprapave@uwo.ca

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Measured at week 0.
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.
Measured at week 2.
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.
Measured at week 4.
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.
Measured at week 6.
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.
Measured at week 12.
Objectively measured total sedentary behaviour
Time Frame: Measured at week 0.
Measured by the ACTIVPAL4
Measured at week 0.
Objectively measured total sedentary behaviour
Time Frame: Measured at week 6.
Measured by the ACTIVPAL4
Measured at week 6.
Objectively measured total sedentary behaviour
Time Frame: Measured at week 12.
Measured by the ACTIVPAL4
Measured at week 12.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-reported sedentary behaviour break frequency
Time Frame: Measured at week 0.
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
Time Frame: Measured at week 2.
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
Time Frame: Measured at week 4.
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
Time Frame: Measured at week 6.
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
Time Frame: Measured at week 12.
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
Time Frame: Measured at week 0.
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
Time Frame: Measured at week 2.
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
Time Frame: Measured at week 4.
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
Time Frame: Measured at week 6.
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
Time Frame: Measured at week 12.
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
Time Frame: Measured at week 0.
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
Time Frame: Measured at week 2.
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
Time Frame: Measured at week 4.
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
Time Frame: Measured at week 6.
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
Time Frame: Measured at week 12.
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
Time Frame: Measured at week 0.
Measured by the ACTIVPAL4
Measured at week 0.
Objective sedentary behaviour break frequency
Time Frame: Measured at week 6.
Measured by the ACTIVPAL4
Measured at week 6.
Objective sedentary behaviour break frequency
Time Frame: Measured at week 12.
Measured by the ACTIVPAL4
Measured at week 12.
Objective sedentary behaviour break duration
Time Frame: Measured at week 0.
Measured by the ACTIVPAL4
Measured at week 0.
Objective sedentary behaviour break duration
Time Frame: Measured at week 6.
Measured by the ACTIVPAL4
Measured at week 6.
Objective sedentary behaviour break duration
Time Frame: Measured at week 12.
Measured by the ACTIVPAL4
Measured at week 12.
Self-reported quality of life
Time Frame: Measured at week 0.
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
Time Frame: Measured at week 6.
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
Time Frame: Measured at week 12.
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
Time Frame: Measured at week 6.
The intervention group will receive at qualitative interview
Measured at week 6.
Validate the modified sedentary behaviour questionnaire (SBQ)
Time Frame: Measured at week 0.
The modified sedentary behaviour (SBQ) will be validated with the ACTIVPAL4
Measured at week 0.
Validate the modified SIT-Q (no unabbreviated name) questionnaire
Time Frame: Measured at week 0.
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)
Time Frame: Measured at week 6.
The modified sedentary behaviour (SBQ) will be validated with the ACTIVPAL4
Measured at week 6.
Validate the modified SIT-Q (no unabbreviated name) questionnaire
Time Frame: Measured at week 6.
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)
Time Frame: Measured at week 12.
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
Time Frame: Measured at week 12.
The modified SIT-Q (no unabbreviated name) questionnaires will be validated with the ACTIVPAL4
Measured at week 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Western University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Harry Prapavessis, PhD, Western University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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