Prediabetes Clinical Trial
— HCOfficial title:
Health Coaching to Effect Lifestyle Behaviour Change: A Randomized Trial of Individuals With Pre-disease
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 |
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.
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 |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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 |
Lead Sponsor | Collaborator |
---|---|
Marshal Godwin | Canadian Institutes of Health Research (CIHR) |
Canada,
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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