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Electronically Connected Health Coaching in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02036892
Recruitment Status : Unknown
Verified January 2014 by Paul Ritvo, York University.
Recruitment status was:  Recruiting
First Posted : January 15, 2014
Last Update Posted : January 15, 2014
Sponsor:
Collaborator:
Public Health Agency of Canada (PHAC)
Information provided by (Responsible Party):
Paul Ritvo, York University

Brief Summary:
Patients with Type 2 Diabetes randomly allocated to the intervention arm (health coaching + smartphone-based health promotion software) will have significantly better Hemoglobin A1c levels at 6 months post-intervention than patients with Type 2 Diabetes allocated to the control arm (health coaching alone).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Lifestyle counseling with smartphone Behavioral: Lifestyle counseling Phase 3

Detailed Description:

Inclusion criteria: all participating patients have been diagnosed with Type 2 Diabetes, are between 25 and 70 years of age, have a regular primary care physician, and have HbA1c levels > or = to 7.3.

Exclusion criteria: Axis I and II psychiatric disorders.

Primary outcome: HBA1c at 6 months follow up.

Secondary outcome: Centre for Epidemiological Studies Depression Scale


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Electronically Connected Health Coaching in Improving Type 2 Diabetes Self Management - Phase III Trial
Study Start Date : February 2012
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lifestyle counseling with smartphones
Lifestyle counseling assisted by smartphones
Behavioral: Lifestyle counseling with smartphone
Lifestyle counseling with health promoting smartphone software
Active Comparator: Lifestyle counseling
Lifestyle counseling
Behavioral: Lifestyle counseling
Lifestyle counseling



Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: 6 months follow up from baseline ]
    Finger prick A1c test or lab test


Secondary Outcome Measures :
  1. Center for Epidemiological Studies Depression Scale [ Time Frame: 6 months follow up from baseline assessment ]
    Self report measure of psychological distress



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Type 2 Diabetes
  • Fluency in English and/or Spanish

Exclusion Criteria:

  • > 75 years of age

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): NCT02036892


Contacts
Contact: Paul Ritvo, PhD 4165808021 pritvo@yorku.ca
Contact: Noah Wayne, MSc 4168897289 noahwayne@gmail.com

Locations
Canada, Ontario
Black Creek Community Health Centre Recruiting
Toronto, Ontario, Canada, M3M1A4
Contact: Paul Ritvo, PhD    4165808021    pritvo@yorku.ca   
Contact: Noah Wayne, MSc    4168897289    NoahWayne@gmail.com   
Sub-Investigator: Noah Wayne, MSc         
Sponsors and Collaborators
York University
Public Health Agency of Canada (PHAC)
Investigators
Principal Investigator: Paul Ritvo, PhD York University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paul Ritvo, Associate Professor, School of Kinesiology and Health Science, York University
ClinicalTrials.gov Identifier: NCT02036892     History of Changes
Other Study ID Numbers: 13-001
First Posted: January 15, 2014    Key Record Dates
Last Update Posted: January 15, 2014
Last Verified: January 2014

Keywords provided by Paul Ritvo, York University:
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases