Electronically Connected Health Coaching in Type 2 Diabetes
1 other identifier
interventional
115
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 type-2-diabetes
Started Feb 2012
Typical duration for phase_3 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 6, 2014
CompletedFirst Posted
Study publicly available on registry
January 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJanuary 15, 2014
January 1, 2014
2.2 years
January 6, 2014
January 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin A1c
Finger prick A1c test or lab test
6 months follow up from baseline
Secondary Outcomes (1)
Center for Epidemiological Studies Depression Scale
6 months follow up from baseline assessment
Study Arms (2)
Lifestyle counseling with smartphones
EXPERIMENTALLifestyle counseling assisted by smartphones
Lifestyle counseling
ACTIVE COMPARATORLifestyle counseling
Interventions
Lifestyle counseling with health promoting smartphone software
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Type 2 Diabetes
- Fluency in English and/or Spanish
You may not qualify if:
- \> 75 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- York Universitylead
- Public Health Agency of Canada (PHAC)collaborator
Study Sites (1)
Black Creek Community Health Centre
Toronto, Ontario, M3M1A4, Canada
Related Publications (2)
Wayne N, Perez DF, Kaplan DM, Ritvo P. Health Coaching Reduces HbA1c in Type 2 Diabetic Patients From a Lower-Socioeconomic Status Community: A Randomized Controlled Trial. J Med Internet Res. 2015 Oct 5;17(10):e224. doi: 10.2196/jmir.4871.
PMID: 26441467DERIVEDPludwinski S, Ahmad F, Wayne N, Ritvo P. Participant experiences in a smartphone-based health coaching intervention for type 2 diabetes: A qualitative inquiry. J Telemed Telecare. 2016 Apr;22(3):172-8. doi: 10.1177/1357633X15595178. Epub 2015 Jul 21.
PMID: 26199275DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Ritvo, PhD
York University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, School of Kinesiology and Health Science
Study Record Dates
First Submitted
January 6, 2014
First Posted
January 15, 2014
Study Start
February 1, 2012
Primary Completion
May 1, 2014
Study Completion
June 1, 2014
Last Updated
January 15, 2014
Record last verified: 2014-01