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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05505864
Enrollment
52
Registered
2022-08-18
Start date
2022-10-01
Completion date
2023-09-30
Last updated
2023-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult ALL, Diabetes Mellitus, Type 2, Sedentary Behavior

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.

Interventions

BEHAVIORALHealth Action Process Approach (HAPA)

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

Sponsors

Western University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Self-reported total sedentary behaviourMeasured 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.
Objectively measured total sedentary behaviourMeasured at week 0.Measured by the ACTIVPAL4

Secondary

MeasureTime frameDescription
Self-reported screen timeMeasured 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.
Objective sedentary behaviour break frequencyMeasured at week 0.Measured by the ACTIVPAL4
Objective sedentary behaviour break durationMeasured at week 0.Measured by the ACTIVPAL4
Self-reported sedentary behaviour break frequencyMeasured 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.
Overall experience of the interventionMeasured at week 6.The intervention group will receive at qualitative interview
Validate the modified sedentary behaviour questionnaire (SBQ)Measured at week 0.The modified sedentary behaviour (SBQ) will be validated with the ACTIVPAL4
Validate the modified SIT-Q (no unabbreviated name) questionnaireMeasured at week 0.The modified SIT-Q (no unabbreviated name) questionnaires will be validated with the ACTIVPAL4
Self-reported quality of lifeMeasured 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).
Self-reported sedentary behaviour break durationMeasured 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.

Countries

Canada

Contacts

Primary ContactHarry Prapavessis, PhD
hprapave@uwo.ca519 661-2111
Backup ContactSiobhan Smith, MA
ssmit422@uwo.ca

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026