Back to resultsHealth Coaching to Effect Lifestyle Behaviour Change (HC)
Primary Purpose
Prediabetes, Prehypertension
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Health Coaching
Sponsored by
About this trial
This is an interventional prevention trial for Prediabetes
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
Sites / Locations
- Memorial University of Newfoundland
- Memorial University of Newfoundland
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Health Coaching
Usual Care -Control
Arm Description
Patients assigned to the control (usual care) group will be advised to seek standard lifestyle counselling from their primary care physician.
Outcomes
Primary Outcome Measures
Change from baseline in lifestyle behaviours as measured by the Simple Lifestyle Indicator Questionnaire
Secondary Outcome Measures
Change from baseline in Self-efficacy
Change from baseline in score on the Framingham-based Global Risk Assessment
Change from baseline in blood pressure as measured by the BpTRU device
Change from baseline in fasting blood glucose and HbA1c as measured by the Cholestech Analyser
Change from baseline in health related quality of life
Full Information
NCT ID
NCT01458496
First Posted
October 18, 2011
Last Updated
March 14, 2016
Sponsor
Marshal Godwin
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT01458496
Brief Title
Health Coaching to Effect Lifestyle Behaviour Change
Acronym
HC
Official Title
Health Coaching to Effect Lifestyle Behaviour Change: A Randomized Trial of Individuals With Pre-disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marshal Godwin
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes, Prehypertension
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
219 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Health Coaching
Arm Type
Experimental
Arm Title
Usual Care -Control
Arm Type
No Intervention
Arm Description
Patients assigned to the control (usual care) group will be advised to seek standard lifestyle counselling from their primary care physician.
Intervention Type
Behavioral
Intervention Name(s)
Health Coaching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in lifestyle behaviours as measured by the Simple Lifestyle Indicator Questionnaire
Time Frame
baseline, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Change from baseline in Self-efficacy
Time Frame
baseline, 6 months, 12 months
Title
Change from baseline in score on the Framingham-based Global Risk Assessment
Time Frame
baseline, 6 months, 12 months
Title
Change from baseline in blood pressure as measured by the BpTRU device
Time Frame
baseline, 6 months, 12 months
Title
Change from baseline in fasting blood glucose and HbA1c as measured by the Cholestech Analyser
Time Frame
baseline, 6 months, 12 months
Title
Change from baseline in health related quality of life
Time Frame
baseline, 6 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marshall Godwin, MD, MSc
Organizational Affiliation
Memorial University of Newfoundland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial University of Newfoundland
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Memorial University of Newfoundland
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1N 3V6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Health Coaching to Effect Lifestyle Behaviour Change
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