Status:
UNKNOWN
Lifestyle Strategies for Improving Diabetes Outcomes
Lead Sponsor:
Tom Elliott
Conditions:
Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to investigate whether a behavioral modification intervention in the form of either a 6-month supervised training program or a 6-month financial incentive weight loss pr...
Detailed Description
This is a single-center, prospective, unblinded, randomized, controlled, clinical trial of 200 subjects randomized to either a Supervised Training Program (STP), Incentivized Weight Loss (IWL) or Stan...
Eligibility Criteria
Inclusion
- Age 18 or older.
- Have been diagnosed with Type 2 diabetes by CDA guidelines.
- A1c \> 8.0 no more than 30 days prior to randomization and confirmed at the time of randomization.
- Overweight or obese as defined by BMI of \>25.
Exclusion
- Have medical co-morbidities that limit their exercise capacity (terminal cancer, severe physical disability such as limb amputation, blindness, seizure disorder, strokes with residual deficits, arrhythmias that would limit physical activity).
- Alcohol or drug abuse that would interfere with exercise regimen.
- Cannot read or write English (with the assistance of an interpreter) or are unable to fill out logs and questionnaire.
- Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
- Patients for whom an exercise program is deemed medically inadvisable.
- Patients already enrolled in a supervised training program.
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02210845
Start Date
July 1 2018
End Date
December 1 2021
Last Update
February 20 2017
Active Locations (1)
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1
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z1M9