Lifestyle Strategies for Improving Diabetes Outcomes
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|ClinicalTrials.gov Identifier: NCT02210845|
Recruitment Status : Not yet recruiting
First Posted : August 7, 2014
Last Update Posted : February 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Behavioral: Supervised exercise Behavioral: Financially incentivized weight Loss Other: Standard Care at BCDiabetes||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Two Lifestyle Strategies for Improving Diabetes Related Health Outcomes in a Specialty Care Setting: A Randomized Controlled Trial|
|Estimated Study Start Date :||July 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
Active Comparator: Financially incentivized weight loss
Participants can be assigned to the financially incentivized weight loss group in which they can receive 50 dollars at the end of the month if they achieve their monthly weight loss goal.
Behavioral: Financially incentivized weight Loss
Financially incentivized weight loss encourages participants to achieve a monthly goal weight reduction for a 50 dollars prize.
Placebo Comparator: Standard of Care
Participants can be assigned to standard of care where they receive no intervention.
Other: Standard Care at BCDiabetes
usual care dictated by GCP at BCDiabetes.ca
Active Comparator: Supervised Exercise
Participants can be assigned to the supervised exercise arm which they will receive supervised professional training once a week.
Behavioral: Supervised exercise
Supervised exercise intervention is training with professional trainers once a week. It will include aerobic exercise tailored to the individual participant.
- Three months average blood glucose (A1c) [ Time Frame: at 3 months and 6 months ]We will assess the effect of supervised training and financially incentivized weight loss on three month average blood glucose in patients with diabetes.
- apo B [ Time Frame: 6 months ]proportion of patientst achieving apoB <0.8 mmol/L
- systolic blood pressure (SBP) [ Time Frame: 3 months and 6 months ]proportion of patients achieving SBP < 140 mmHg
- A1c [ Time Frame: 3 months and 6 months ]proportion of patients achieving A1c < 7.0%
- Composite: Psychosocial outcomes are depressive symptoms, Diabetes specific quality of life [ Time Frame: 3 months and 6 months, ]this composite outcome will reflect overall change in QoL scoring during study
- waist circumference [ Time Frame: 3 months and 6 months, ]Waist circumference
- weight [ Time Frame: 3 months and 6 months, ]weight
- body mass index (BMI) [ Time Frame: 3 months and 6 months, ]BMI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210845
|Contact: Mandana Moosavi, MDCMfirstname.lastname@example.org|
|Contact: Tom Elliott, MDemail@example.com|
|Canada, British Columbia|
|Vancouver General Hospital|
|Vancouver, British Columbia, Canada, V5Z1M9|
|Principal Investigator: Tom Elliott, MD|
|Principal Investigator:||Tom Elliott, MD||BCDiabetes.Ca|