Health Coaching to Effect Lifestyle Behaviour Change

NCT ID: NCT01458496

Last Updated: 2016-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 219 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2015-12-31

Brief Summary

A health coaching intervention in those with pre-disease (pre-hypertension or pre-diabetes) but without pre-existing cardiovascular disease will effectively help participants change their lifestyle behaviour and prevent or delay onset of cardiovascular disease.

Conditions

Prediabetes; Prehypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Health Coaching

Group Type: EXPERIMENTAL

Health Coaching

Intervention Type: BEHAVIORAL

The intervention will take approximately six months to complete. A combination of group and individual face-to-face meetings will be used. Participants will be divided into groups of 20 for group meetings. Groups will be brought together for a group coaching session at the beginning and the end of the coaching process (i.e., intervention). Each participant will also receive four individual coaching sessions with the health coach and will be able to avail of three one-hour telephone coaching sessions during the six month intervention. Participants will be encouraged to utilize telephone coaching for key support periods.

Usual Care -Control

Patients assigned to the control (usual care) group will be advised to seek standard lifestyle counselling from their primary care physician.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Health Coaching

The intervention will take approximately six months to complete. A combination of group and individual face-to-face meetings will be used. Participants will be divided into groups of 20 for group meetings. Groups will be brought together for a group coaching session at the beginning and the end of the coaching process (i.e., intervention). Each participant will also receive four individual coaching sessions with the health coach and will be able to avail of three one-hour telephone coaching sessions during the six month intervention. Participants will be encouraged to utilize telephone coaching for key support periods.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 40-60 years
• Last recorded fasting blood glucose between 6.0 abd 6.9 mmol/L
• Last recorded blood pressure between 130-139 mmHG systolic and/or85-89 mmHG diastolic

Exclusion Criteria

• Diagnosis of diabetes on the chart
• Diagnosis of hypertension on the chart
• taking an anti-diabetic medication
• taking an antihypertensive medication

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Marshal Godwin

OTHER

Sponsor Role: lead

Responsible Party

Marshal Godwin

Professor, Faculty of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marshall Godwin, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Memorial University of Newfoundland

Locations

Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, Canada

Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, Canada

Countries

Canada

Other Identifiers

243401

Identifier Type: -

Identifier Source: org_study_id