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Exercise Programme and Counselling for Telemedicine

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Telemedicine+3 MoreExercise Programme and Counselling - Behavioral
Eligibility
40 - 75
All Sexes
What conditions do you have?
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Study Summary

This trial is investigating whether receiving support through an exercise specialist and using a fitness watch with a mobile App can help people with Type 2 diabetes to be more physically active and exercise regularly.

Eligible Conditions
  • Telemedicine
  • Physical Therapy/Exercise Therapy
  • Mobile Apps
  • Type 2 Diabetes

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

4 Primary · 10 Secondary · Reporting Duration: 0-6 months, 0-12 months

Month 12
Adherence to exercise
Behavioural regulation in exercise
Body Weight Changes
Change in blood pressure
Change in body composition
Change in glycaemic control
Change in waist circumference
Change in weight
Determine availability and completeness of economic data
Determine healthcare usage
Diabetes related quality of life
Patient rapport with counsellor
0-12 months
Determine the number of adults with newly diagnosed T2D that are eligible to participate in the trial
Ensure that our plans for recruitment, randomisation, treatment, and follow-up are acceptable to patients
The characteristics of these adults with newly diagnosed T2D who are willing to take part in the trial
The number and percentage of participants retained at 12-months.
Diabetes Mellitus, Non-Insulin-Dependent
0-6 months, 0-12 months
Acceptability and feasibility of patients continuing the intervention on their own
Acceptability and feasibility of the wearable intervention to patients
Month 1
Pilot methods for collecting outcome measures

Trial Safety

Safety Progress

1 of 3

Similar Trials

2
canagliflozin
3
Metformin DR
3
Pneumovax 23- pneumococcal polysaccharide

Trial Design

2 Treatment Groups

Exercise Counselling
1 of 2
mHealth Technology
1 of 2

Active Control

Experimental Treatment

120 Total Participants · 2 Treatment Groups

Primary Treatment: Exercise Programme and Counselling · No Placebo Group · N/A

mHealth TechnologyExperimental Group · 2 Interventions: Polar Ignite and App, Exercise Programme and Counselling · Intervention Types: Device, Behavioral
Exercise Counselling
Behavioral
ActiveComparator Group · 1 Intervention: Exercise Programme and Counselling · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 0-6 months, 0-12 months

Who is running the clinical trial?

Medical Research CouncilOTHER_GOV
302 Previous Clinical Trials
1,953,107 Total Patients Enrolled
Lancaster UniversityOTHER
18 Previous Clinical Trials
3,939 Total Patients Enrolled
University of ExeterOTHER
152 Previous Clinical Trials
1,364,736 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,233 Previous Clinical Trials
24,676,532 Total Patients Enrolled
University of British ColumbiaLead Sponsor
1,327 Previous Clinical Trials
1,534,467 Total Patients Enrolled
Liverpool John Moores UniversityOTHER
66 Previous Clinical Trials
7,588 Total Patients Enrolled

Eligibility Criteria

Age 40 - 75 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The person was recently diagnosed with type 2 diabetes.
If you have diabetes, you can treat it with Metformin, diet and exercise, or just Metformin.
People who have been prescribed Metformin and have been using a stable dose for three months or more may be able to stop taking the medication.
References

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