Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lifestyle Strategies for Improving Diabetes Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02210845
Recruitment Status : Not yet recruiting
First Posted : August 7, 2014
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Tom Elliott, BCDiabetes.Ca

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 program, results in improvement of diabetes outcome such as overall sugar control and lipid control.

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Supervised exercise Behavioral: Financially incentivized weight Loss Other: Standard Care at BCDiabetes Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. apo B [ Time Frame: 6 months ]
    proportion of patientst achieving apoB <0.8 mmol/L

  2. systolic blood pressure (SBP) [ Time Frame: 3 months and 6 months ]
    proportion of patients achieving SBP < 140 mmHg

  3. A1c [ Time Frame: 3 months and 6 months ]
    proportion of patients achieving A1c < 7.0%


Other Outcome Measures:
  1. 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

  2. waist circumference [ Time Frame: 3 months and 6 months, ]
    Waist circumference

  3. weight [ Time Frame: 3 months and 6 months, ]
    weight

  4. body mass index (BMI) [ Time Frame: 3 months and 6 months, ]
    BMI



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18 or older.
  2. Have been diagnosed with Type 2 diabetes by CDA guidelines.
  3. A1c > 8.0 no more than 30 days prior to randomization and confirmed at the time of randomization.
  4. Overweight or obese as defined by BMI of >25.

Exclusion Criteria:

  1. 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).
  2. Alcohol or drug abuse that would interfere with exercise regimen.
  3. Cannot read or write English (with the assistance of an interpreter) or are unable to fill out logs and questionnaire.
  4. Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
  5. Patients for whom an exercise program is deemed medically inadvisable.
  6. Patients already enrolled in a supervised training program.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Mandana Moosavi, MDCM 6043604704 mandana.moosavi@mail.mcgill.ca
Contact: Tom Elliott, MD 6046752491 telliott@bcdiabetes.ca

Locations
Layout table for location information
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z1M9
Principal Investigator: Tom Elliott, MD         
Sponsors and Collaborators
Tom Elliott
Investigators
Layout table for investigator information
Principal Investigator: Tom Elliott, MD BCDiabetes.Ca
Publications:
Layout table for additonal information
Responsible Party: Tom Elliott, Clinical Associate Professor, BCDiabetes.Ca
ClinicalTrials.gov Identifier: NCT02210845    
Other Study ID Numbers: DOS-23
First Posted: August 7, 2014    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD to other researchers except those involved in the trial

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tom Elliott, BCDiabetes.Ca:
Diabetes
Supervised Exercise
Weight loss
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases