Electronically Connected Health Coaching in Type 2 Diabetes

Phase 3

• Conditions: Type 2 Diabetes

• 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

Study Timeline

• Study Start: 2012-02
• Status Verified: 2014-01
• Study First Submitted: 2014-01-06
• Study First Submitted QC: 2014-01-13
• Last Update Submitted: 2014-01-13
• Study First Posted: 2014-01-15
• Last Update Posted: 2014-01-15
• Primary Completion: 2014-05
• Study Completion: 2014-06

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

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c	6 months follow up from baseline	Finger prick A1c test or lab test

Secondary Outcome Measures

Name	Time	Method
Center for Epidemiological Studies Depression Scale	6 months follow up from baseline assessment	Self report measure of psychological distress

Trial Locations

Locations (1)

Black Creek Community Health Centre; 🇨🇦 Toronto, Ontario, Canada