Electronically Connected Health Coaching in Type 2 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by York University
Sponsor:
Collaborator:
Public Health Agency of Canada (PHAC)
Information provided by (Responsible Party):
Paul Ritvo, York University
ClinicalTrials.gov Identifier:
NCT02036892
First received: January 6, 2014
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Type 2 Diabetes
Behavioral: Lifestyle counseling with smartphone
Behavioral: Lifestyle counseling
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Electronically Connected Health Coaching in Improving Type 2 Diabetes Self Management - Phase III Trial

Resource links provided by NLM:


Further study details as provided by York University:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 6 months follow up from baseline ] [ Designated as safety issue: No ]
    Finger prick A1c test or lab test


Secondary Outcome Measures:
  • Center for Epidemiological Studies Depression Scale [ Time Frame: 6 months follow up from baseline assessment ] [ Designated as safety issue: No ]
    Self report measure of psychological distress


Estimated Enrollment: 115
Study Start Date: February 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: January 6, 2014
Last Updated: January 13, 2014
Health Authority: Canada: Public Health Agency of Canada

Keywords provided by York University:
Diabetes

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

ClinicalTrials.gov processed this record on October 23, 2014