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Health Coaching to Effect Lifestyle Behaviour Change (HC)

This study is currently recruiting participants.
Verified November 2012 by Memorial University of Newfoundland
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Marshal Godwin, Memorial University of Newfoundland
ClinicalTrials.gov Identifier:
NCT01458496
First received: October 18, 2011
Last updated: November 9, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Prediabetes
Prehypertension
 Behavioral: Health Coaching

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Health Coaching to Effect Lifestyle Behaviour Change: A Randomized Trial of Individuals With Pre-disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial University of Newfoundland:

Primary Outcome Measures:
  • Change from baseline in lifestyle behaviours as measured by the Simple Lifestyle Indicator Questionnaire [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Self-efficacy [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in score on the Framingham-based Global Risk Assessment [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in blood pressure as measured by the BpTRU device [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in fasting blood glucose and HbA1c as measured by the Cholestech Analyser [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in health related quality of life [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458496

Contacts
Contact: Marshall Godwin, MD, MSc 709-777-8373 godwinm@mun.ca

Locations
Canada, Newfoundland and Labrador
Memorial University of Newfoundland Recruiting
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Contact: Marshall Godwin, MD, MSc     709-777-8373     godwinm@mun.ca    
Principal Investigator: Marshall Godwin, MD, MSc            
Memorial University of Newfoundland Recruiting
St. John's, Newfoundland and Labrador, Canada, A1N 3V6
Contact: Janice Peach            
Sub-Investigator: Andrea E Pike, MSc            
Sub-Investigator: Farah McCrate, MSc            
Sub-Investigator: Veeresh Gadag, PhD            
Sub-Investigator: Holly Etchegary, PhD            
Sub-Investigator: Kris Aubrey, MSc, MD            
Sub-Investigator: Alice Gaudine, PhD            
Sub-Investigator: Sandra LeFort, PhD            
Sub-Investigator: Shabnam Asghari, MD, MPH, PhD            
Sub-Investigator: Shirley Solberg, PhD            
Sponsors and Collaborators
Marshal Godwin
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Marshall Godwin, MD, MSc Memorial University of Newfoundland
  More Information

No publications provided

Responsible Party: Marshal Godwin, Professor, Faculty of Medicine, Memorial University of Newfoundland
ClinicalTrials.gov Identifier: NCT01458496     History of Changes
Other Study ID Numbers: 243401
Study First Received: October 18, 2011
Last Updated: November 9, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Glucose Intolerance
Prediabetic State
Prehypertension
Hyperglycemia
Glucose Metabolism Disorders
 Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013