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

Western University

Status: Enrolling

Conditions: Adult ALL; Diabetes Mellitus, Type 2; Sedentary Behavior

Treatments: Behavioral: Health Action Process Approach (HAPA)

Study type: Interventional

Funder types: Other

Identifiers

NCT05505864

120585

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Intervention Group

Experimental group

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.

Treatment:

Behavioral: Health Action Process Approach (HAPA)

Control Group

No Intervention group

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.