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Health Coaching to Effect Lifestyle Behaviour Change (HC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01458496
First Posted: October 24, 2011
Last Update Posted: March 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Marshal Godwin, Memorial University of Newfoundland
  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: None (Open Label)
Primary Purpose: Prevention
Official Title: Health Coaching to Effect Lifestyle Behaviour Change: A Randomized Trial of Individuals With Pre-disease

Further study details as provided by Marshal Godwin, 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 ]

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

Enrollment: 219
Study Start Date: October 2011
Study Completion Date: December 2015
Primary Completion Date: December 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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01458496


Locations
Canada, Newfoundland and Labrador
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, Canada, A1N 3V6
Sponsors and Collaborators
Marshal Godwin
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Marshall Godwin, MD, MSc Memorial University of Newfoundland
  More Information

Responsible Party: Marshal Godwin, Professor, Faculty of Medicine, Memorial University of Newfoundland
ClinicalTrials.gov Identifier: NCT01458496     History of Changes
Other Study ID Numbers: 243401
First Submitted: October 18, 2011
First Posted: October 24, 2011
Last Update Posted: March 16, 2016
Last Verified: March 2016

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