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

NCT ID: NCT05505864

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-09-30

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.

Conditions

Sedentary Behavior; Diabetes Mellitus, Type 2; Adult ALL

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Health Action Process Approach (HAPA)

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Health Action Process Approach (HAPA)

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western University

OTHER

Sponsor Role: lead

Responsible Party

Siobhan Smith

Dr Harry Prapavessis, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Harry Prapavessis, PhD

Role: PRINCIPAL_INVESTIGATOR

Western University

Locations

Harry Prapavessis

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Harry Prapavessis, PhD

Role: CONTACT

hprapave@uwo.ca

519 661-2111 ext. 80173

Siobhan Smith, MA

Role: CONTACT

ssmit422@uwo.ca

Facility Contacts

Harry Prapavessis, PhD

Role: primary

hprapave@uwo.ca

519 661-2111 ext. 80173

Other Identifiers

120585

Identifier Type: -

Identifier Source: org_study_id