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Status unknownNCT02036892Updated Jan 15, 2014

Electronically Connected Health Coaching in Type 2 Diabetes

A Phase 3 interventional study of Lifestyle counseling with smartphone and Lifestyle counseling in Type 2 Diabetes, sponsored by York University. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-01-15.

Sponsored by York University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
115
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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).

Read the 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

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • Diabetes
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 115 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

York University is the lead sponsor of 51 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • > 75 years of age
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
115 participants (estimated)

Study arms

  • Experimental
    Lifestyle counseling with smartphones

    Lifestyle counseling assisted by smartphones

    Behavioral: Lifestyle counseling with smartphone

  • Active comparator
    Lifestyle counseling

    Lifestyle counseling

    Behavioral: Lifestyle counseling

Interventions

  • BehavioralLifestyle counseling with smartphone

    Lifestyle counseling with health promoting smartphone software

  • BehavioralLifestyle counseling

    Lifestyle counseling

06

What researchers measure

Primary outcomes

  1. Hemoglobin A1c

    Finger prick A1c test or lab test

    Time frame: 6 months follow up from baseline

Secondary outcomes

  1. Center for Epidemiological Studies Depression Scale

    Self report measure of psychological distress

    Time frame: 6 months follow up from baseline assessment

07

Study locations

1 of 1 sites recruiting
  • Black Creek Community Health Centre
    Toronto, Ontario M3M1A4, Canada
    Recruiting
08

References and documents

Publications

  • 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. PubMed 26441467 ↗
  • Pludwinski 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. PubMed 26199275 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02036892
Lead sponsor
York University
Collaborators
Public Health Agency of Canada (PHAC)
Responsible party
Paul Ritvo (Associate Professor, School of Kinesiology and Health Science, York University) — Principal investigator
First posted
Jan 15, 2014
Start date
Feb 2012
Primary completion
May 2014 (estimated)
Completion
Jun 2014 (estimated)
Last update
Jan 15, 2014

Study contacts

Paul Ritvo, PhD
Contact
pritvo@yorku.ca
4165808021
Noah Wayne, MSc
Contact
noahwayne@gmail.com
4168897289
Paul Ritvo, PhD
principal investigator · York University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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