Health Coaching to Effect Lifestyle Behaviour Change (HC)

Health Coaching to Effect Lifestyle Behaviour Change: A Randomized Trial of Individuals With Pre-disease

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.

Study Overview

• Status: Completed
• Conditions: Prehypertension; Prediabetes
• Intervention / Treatment: Behavioral: Health Coaching

• Study Type: Interventional
• Enrollment (Actual): 219
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Memorial University of Newfoundland
    • St. John's, Newfoundland and Labrador, Canada, A1N 3V6
      • Memorial University of Newfoundland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health Coaching	Behavioral: 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.
No Intervention: Usual Care -Control; Patients assigned to the control (usual care) group will be advised to seek standard lifestyle counselling from their primary care physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in lifestyle behaviours as measured by the Simple Lifestyle Indicator Questionnaire	baseline, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Self-efficacy	baseline, 6 months, 12 months
Change from baseline in score on the Framingham-based Global Risk Assessment	baseline, 6 months, 12 months
Change from baseline in blood pressure as measured by the BpTRU device	baseline, 6 months, 12 months
Change from baseline in fasting blood glucose and HbA1c as measured by the Cholestech Analyser	baseline, 6 months, 12 months
Change from baseline in health related quality of life	baseline, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Marshal Godwin
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Marshall Godwin, MD, MSc, Memorial University of Newfoundland

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 18, 2011
• First Submitted That Met QC Criteria: October 20, 2011
• First Posted (Estimate): October 24, 2011

Study Record Updates

• Last Update Posted (Estimate): March 16, 2016
• Last Update Submitted That Met QC Criteria: March 14, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Prehypertension
• Other Study ID Numbers: 243401