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:
York University
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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
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, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on March 03, 2015