Clinical trial NCT05505864: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Sedentary Behavior
Diabetes Mellitus, Type 2
Adult ALL
Lead sponsor: Western University
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Self-reported total sedentary behaviour
timeFrame: Measured at week 0.
measure: Self-reported total sedentary behaviour
timeFrame: Measured at week 2.
measure: Self-reported total sedentary behaviour
timeFrame: Measured at week 4.
measure: Self-reported total sedentary behaviour
timeFrame: Measured at week 6.
measure: Self-reported total sedentary behaviour
timeFrame: Measured at week 12.
measure: Objectively measured total sedentary behaviour
timeFrame: Measured at week 0.
measure: Objectively measured total sedentary behaviour
timeFrame: Measured at week 6.
measure: Objectively measured total sedentary behaviour
timeFrame: Measured at week 12.
Secondary outcomes:
measure: Self-reported sedentary behaviour break frequency
timeFrame: Measured at week 0.
measure: Self-reported sedentary behaviour break frequency
timeFrame: Measured at week 2.
measure: Self-reported sedentary behaviour break frequency
timeFrame: Measured at week 4.
measure: Self-reported sedentary behaviour break frequency
timeFrame: Measured at week 6.
measure: Self-reported sedentary behaviour break frequency
timeFrame: Measured at week 12.
measure: Self-reported sedentary behaviour break duration
timeFrame: Measured at week 0.
measure: Self-reported sedentary behaviour break duration
timeFrame: Measured at week 2.
measure: Self-reported sedentary behaviour break duration
timeFrame: Measured at week 4.
measure: Self-reported sedentary behaviour break duration
timeFrame: Measured at week 6.
measure: Self-reported sedentary behaviour break duration
timeFrame: Measured at week 12.
measure: Self-reported screen time
timeFrame: Measured at week 0.
measure: Self-reported screen time
timeFrame: Measured at week 2.
measure: Self-reported screen time
timeFrame: Measured at week 4.
measure: Self-reported screen time
timeFrame: Measured at week 6.
measure: Self-reported screen time
timeFrame: Measured at week 12.
measure: Objective sedentary behaviour break frequency
timeFrame: Measured at week 0.
measure: Objective sedentary behaviour break frequency
timeFrame: Measured at week 6.
measure: Objective sedentary behaviour break frequency
timeFrame: Measured at week 12.
measure: Objective sedentary behaviour break duration
timeFrame: Measured at week 0.
measure: Objective sedentary behaviour break duration
timeFrame: Measured at week 6.
measure: Objective sedentary behaviour break duration
timeFrame: Measured at week 12.
measure: Self-reported quality of life
timeFrame: Measured at week 0.
measure: Self-reported quality of life
timeFrame: Measured at week 6.
measure: Self-reported quality of life
timeFrame: Measured at week 12.
measure: Overall experience of the intervention
timeFrame: Measured at week 6.
measure: Validate the modified sedentary behaviour questionnaire (SBQ)
timeFrame: Measured at week 0.
measure: Validate the modified SIT-Q (no unabbreviated name) questionnaire
timeFrame: Measured at week 0.
measure: Validate the modified sedentary behaviour questionnaire (SBQ)
timeFrame: Measured at week 6.
measure: Validate the modified SIT-Q (no unabbreviated name) questionnaire
timeFrame: Measured at week 6.
measure: Validate the modified sedentary behaviour questionnaire (SBQ)
timeFrame: Measured at week 12.
measure: Validate the modified SIT-Q (no unabbreviated name) questionnaire
timeFrame: Measured at week 12.
Other outcomes:
Locations:
city: London
country: Canada
facility: Harry Prapavessis
state: Ontario
Study officials:
affiliation: Western University
name: Harry Prapavessis, PhD
role: PRINCIPAL_INVESTIGATOR
References: