Electronically Connected Health Coaching in Type 2 Diabetes

NCT ID: NCT02036892

Last Updated: 2014-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-06-30

Brief Summary

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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

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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

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lifestyle counseling with smartphones

Lifestyle counseling assisted by smartphones

Group Type EXPERIMENTAL

Lifestyle counseling with smartphone

Intervention Type BEHAVIORAL

Lifestyle counseling with health promoting smartphone software

Lifestyle counseling

Lifestyle counseling

Group Type ACTIVE_COMPARATOR

Lifestyle counseling

Intervention Type BEHAVIORAL

Lifestyle counseling

Interventions

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Lifestyle counseling with smartphone

Lifestyle counseling with health promoting smartphone software

Intervention Type BEHAVIORAL

Lifestyle counseling

Lifestyle counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* \> 75 years of age
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Public Health Agency of Canada (PHAC)

OTHER_GOV

Sponsor Role collaborator

York University

OTHER

Sponsor Role lead

Responsible Party

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Paul Ritvo

Associate Professor, School of Kinesiology and Health Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Ritvo, PhD

Role: PRINCIPAL_INVESTIGATOR

York University

Locations

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Black Creek Community Health Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Paul Ritvo, PhD

Role: CONTACT

4165808021

Noah Wayne, MSc

Role: CONTACT

4168897289

Facility Contacts

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Paul Ritvo, PhD

Role: primary

4165808021

Noah Wayne, MSc

Role: backup

4168897289

References

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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.

Reference Type DERIVED
PMID: 26441467 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26199275 (View on PubMed)

Other Identifiers

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13-001

Identifier Type: -

Identifier Source: org_study_id

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