Electronically Connected Health Coaching in Type 2 Diabetes

York University

Status and phase: Unknown; Phase 3

Conditions: Type 2 Diabetes

Treatments: Behavioral: Lifestyle counseling with smartphone; Behavioral: Lifestyle counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT02036892

13-001

Details and patient eligibility

About

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).

Full 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

Enrollment: 115 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• > 75 years of age

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 2 patient groups

Lifestyle counseling with smartphones

Experimental group

Description:

Lifestyle counseling assisted by smartphones

Treatment:

Behavioral: Lifestyle counseling with smartphone

Lifestyle counseling

Active Comparator group

Description:

Lifestyle counseling

Treatment:

Behavioral: Lifestyle counseling