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Intervention Group for Type 2 Diabetes

N/A

Recruiting

Led By Harry Prapavessis, PhD

Research Sponsored by Western University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at week 12.

Awards & highlights

Study Summary

This trial will help adults with type 2 diabetes meet guidelines on how much they should move in a day.

Eligible Conditions

Type 2 Diabetes
Sedentary Lifestyle
Acute Lymphoblastic Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at week 12.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at week 12.

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at week 12. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objectively measured total sedentary behaviour

Self-reported total sedentary behaviour

Secondary outcome measures

Objective sedentary behaviour break duration

Objective sedentary behaviour break frequency

Overall experience of the intervention

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention

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 II: Control GroupActive Control1 Intervention

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.

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Who is running the clinical trial?

Western UniversityLead Sponsor

25 Previous Clinical Trials

128,481 Total Patients Enrolled

Harry Prapavessis, PhDPrincipal InvestigatorWestern University

8 Previous Clinical Trials

1,205 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are engaged in this research project?

"Absolutely. According to clinicaltrials.gov, this experiment is still in search of participants and was first announced on October 1st 2022 before being last edited on January 13th 2023. The study's scope calls for 52 patients from one medical centre to be recruited."

Answered by AI

Are any new participants being accepted into this trial at the moment?

"Assertion is accurate. Per records available on clinicaltrials.gov, this study opened recruitment in October 2022 and was recently updated in January 2023; it seeks 52 eligible patients from a single site."

Answered by AI

What objectives is this research endeavor hoping to accomplish?

"At week 12, the principal end goal of this trial will be to gauge objectively total sedentary behaviour. Secondary objectives are quality of life (as judged using a modified SF-36 questionnaire) and validating two questionnaires -modified SIT-Q & SBQ- with ACTIVPAL4 data."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Siobhan Smith 2022. "Assessing Sedentary Behaviour in Adults With Type 2 Diabetes - A Randomized Controlled Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05505864.