NCT02128815

Brief Summary

Background: Health coaching is defined as health education, promotion and support by a professional to enhance the well-being of individuals and facilitate the achievement of their health-related goals. However, health coaching has not been adequately assessed in the community health care setting in individuals with T2DM. The purpose of this study is to determine the effect of diabetes health coaching in adults with T2DM in the community health care setting on clinical outcomes, self-care behaviours and health care utilization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
366

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 29, 2018

Status Verified

September 1, 2017

Enrollment Period

2.9 years

First QC Date

April 28, 2014

Last Update Submit

March 27, 2018

Conditions

Keywords

adultscoachingtype 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • change from baseline A1C after one year

    non-fasting venous blood sample (Hemoglobin A1C assay)

    1 year

Secondary Outcomes (3)

  • BMI

    change from baseline in BMI at 1 year

  • Change from baseline self-care behaviours at 1 year

    1 year

  • change from baseline in quality of life at 1 year

    1 year

Study Arms (2)

Coaching

EXPERIMENTAL

diabetes health coaching + usual diabetes self-management education

Other: Coaching

Usual Care

NO INTERVENTION

Usual care or self-management education

Interventions

Care translation - behaviour modification, personalized/tailored diabetes education and psychosocial support

Coaching

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults 18 years of age or older
  • diagnosed type 2 diabetes
  • A1C equal to or over 7.5%
  • able to read, write and understand English
  • have telephone or internet access

You may not qualify if:

  • adults with impaired cognition
  • cohabiting with a participant in the study
  • pregnant or planning a pregnancy
  • have an underlying medical condition that may provide misleading A1C levels

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Langs Community Health Centre

Cambridge, Ontario, N3H 4L6, Canada

Location

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

Related Publications (1)

  • Sherifali D, Brozic A, Agema P, Punthakee Z, McInnes N, O'Reilly D, Usman Ali RM, Ibrahim S, Gerstein HC. Effect of Diabetes Health Coaching on Glycemic Control and Quality of Life in Adults Living With Type 2 Diabetes: A Community-Based, Randomized, Controlled Trial. Can J Diabetes. 2021 Oct;45(7):594-600. doi: 10.1016/j.jcjd.2020.11.012. Epub 2020 Dec 5.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Diana Sherifali, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2014

First Posted

May 1, 2014

Study Start

January 1, 2015

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

March 29, 2018

Record last verified: 2017-09

Locations