MedPath

Electronically Connected Health Coaching in Type 2 Diabetes

Phase 3
Conditions
Type 2 Diabetes
Interventions
Behavioral: Lifestyle counseling with smartphone
Behavioral: Lifestyle counseling
Registration Number
NCT02036892
Lead Sponsor
York University
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

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
115
Inclusion Criteria
  • Clinical diagnosis of Type 2 Diabetes
  • Fluency in English and/or Spanish
Exclusion Criteria
  • > 75 years of age

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Lifestyle counseling with smartphonesLifestyle counseling with smartphoneLifestyle counseling assisted by smartphones
Lifestyle counselingLifestyle counselingLifestyle counseling
Primary Outcome Measures
NameTimeMethod
Hemoglobin A1c6 months follow up from baseline

Finger prick A1c test or lab test

Secondary Outcome Measures
NameTimeMethod
Center for Epidemiological Studies Depression Scale6 months follow up from baseline assessment

Self report measure of psychological distress

Trial Locations

Locations (1)

Black Creek Community Health Centre

🇨🇦

Toronto, Ontario, Canada

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