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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01458496
Other study ID # 243401
Secondary ID
Status Completed
Phase N/A
First received October 18, 2011
Last updated March 14, 2016
Start date October 2011
Est. completion date December 2015

Study information

Verified date March 2016
Source Memorial University of Newfoundland
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 219
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 60 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Canada Memorial University of Newfoundland St. John's Newfoundland and Labrador
Canada Memorial University of Newfoundland St. John's Newfoundland and Labrador

Sponsors (2)

Lead Sponsor Collaborator
Marshal Godwin Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in lifestyle behaviours as measured by the Simple Lifestyle Indicator Questionnaire baseline, 6 months, 12 months No
Secondary Change from baseline in Self-efficacy baseline, 6 months, 12 months No
Secondary Change from baseline in score on the Framingham-based Global Risk Assessment baseline, 6 months, 12 months No
Secondary Change from baseline in blood pressure as measured by the BpTRU device baseline, 6 months, 12 months No
Secondary Change from baseline in fasting blood glucose and HbA1c as measured by the Cholestech Analyser baseline, 6 months, 12 months No
Secondary Change from baseline in health related quality of life baseline, 6 months, 12 months No
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