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Electronically Connected Health Coaching in Type 2 Diabetes

Electronically Connected Health Coaching in Improving Type 2 Diabetes Self Management - Phase III Trial

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02036892
Enrollment
115
Registered
2014-01-15
Start date
2012-02-29
Completion date
2014-06-30
Last updated
2014-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Diabetes

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).

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

Interventions

BEHAVIORALLifestyle counseling with smartphone

Lifestyle counseling with health promoting smartphone software

BEHAVIORALLifestyle counseling

Lifestyle counseling

Sponsors

Public Health Agency of Canada (PHAC)
CollaboratorOTHER_GOV
York University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* \> 75 years of age

Design outcomes

Primary

MeasureTime frameDescription
Hemoglobin A1c6 months follow up from baselineFinger prick A1c test or lab test

Secondary

MeasureTime frameDescription
Center for Epidemiological Studies Depression Scale6 months follow up from baseline assessmentSelf report measure of psychological distress

Countries

Canada

Contacts

Primary ContactPaul Ritvo, PhD
pritvo@yorku.ca4165808021
Backup ContactNoah Wayne, MSc
noahwayne@gmail.com4168897289

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 16, 2026