Type 2 diabetes Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Interventions
Participants will be randomised to an active control (exercise counselling) or intervention (exercise counselling and mobile health (mHealth)) groups. Patients will be randomised in a 1:1 ratio using
1) a wrist worn fitness watch, featuring a 3d accelerometer and optical heart rate monitor, 2) a smartphone app for patients, and 3) a coaching website for the exercise specialist, and behaviour chang
Sponsors
Liverpool John Moores University
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Clinical Diagnosis of T2D within the previous 5–24 months 2. Aged 40 - 75 years 3. Treating diabetes with only Metformin or lifestyle modifications (diet and exercise) 4. For those prescribed Metformin: Stable dose for 3-months or more
Exclusion criteria
Exclusion criteria: 1. HbA1c >10% (>86mmol/mol) 2. Blood pressure >160/100 mmHg 3. Prescription of oral antidiabetic drug other than Metformin 4. Prescription of Insulin 5. Unstable angina 6. Myocardial infarction within the previous 3 months 7. Transient ischemic attack (TIA) in the previous 6 months 8. Heart failure >= class 2 9. Inability to increase level of activity 10. Pregnancy or planning to become pregnant 11. <6 months postpartum or stopped breastfeeding <1 month before recruitment 12. Not owning a smartphone/ or having no data plan or access to WiFi 13. Currently meeting the recommended exercise guidelines (150 min of moderate intensity exercise per week)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes: 1. The number of adults with newly diagnosed T2D that are eligible to participate 2. The proportion of these who would be willing to take part in this trial (i.e. recruitment rate), and their characteristics 3. The number of participants retained at 12-months (i.e. participant drop-out) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Estimate precision of potential outcome measures required for sample size estimations for the definitive RCT: 1.1. Adherence to structure exercise, measured using heart rate monitoring of all structured exercise sessions, measured throughout the 12-month study period 1.2. Self reported leisure-time exercise, measured using the Godin Leisure-Time Exercise Questionnaire (GLEEQ), measured monthly over 12-month study period 1.3. Device assessed physical activity, measured using a GENEActiv physical activity monitor for 14 days at baseline, post-intervention (6-months) and follow-up (12-months) 1.4. HbA1c, measured using a finger prick blood sample at baseline, post-intervention (6-months) and follow-up (12-months) 1.5. 14-day glycaemic control, measured using Flash Glucose Monitoring for 14-days at baseline, post-intervention (6-months) and follow-up (12-months) 1.6. Body composition, measured using BMI and waist circumference at baseline, post-intervention (6-months) and follow-up (12-months) 1.7. Blood pressure, measured using automated blood pressure monitor at baseline, post-intervention (6-months) and follow-up (12-months) 1.8. Blood Lipids (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides), measured using a finger prick blood sample at baseline, post-intervention (6-months) and follow-up (12-months) 1.9. Health related quality of life, measured using the SF-12 health survey at baseline, post-intervention (6-months) and follow-up (12-months) 1.10. Diabetes Treatment Satisfaction using the Diabetes Treatment Satisfaction Questionnaire status version at baseline, post-intervention (6-months) and follow-up (12-months), and Diabetes Treatment Satisfaction Questionnaire change version at post-intervention (6-months) 1.11. Exercise motivation, measured through the Behavioural Regulation in Exercise Questionnaire at baseline, post-intervention (6-months) and follow-up (12-months) 1.12. Patient rapport with counsellor, measured through the Pati | — |
Countries
Canada, England, United Kingdom
Contacts
Public ContactKatie Hesketh
Outcome results
None listed