Hypertension Clinical Trial
Official title:
Lifestyle Intervention for Treating Systemic Hypertension in Primary Care Setting
| NCT number | NCT02492035 |
| Other study ID # | 20805 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | February 2013 |
| Est. completion date | December 23, 2016 |
| Verified date | October 2020 |
| Source | Laval University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The Canadian hypertension education program recommends increased physical activity, adoption of the Dietary Approaches to Stop Hypertension (DASH) diet, and reduction in sodium and alcohol intake for treatment and prevention of hypertension. Objective: To describe patients participating in an interdisciplinary lifestyle intervention to reduce blood pressure in a family medicine primary care setting. Design: Descriptive study. Participants: The study aims to recruit 60 sedentary hypertensive patients to participate in a 6-month randomized-controlled trial. To be eligible, patients must be ≥18 years of age, sedentary (7-day measured steps/day and self-report), hypertensive (based on 24-h ambulatory blood pressure measurements [ABPM]), non-smoker, non-diabetic and without dyslipidemia. Intervention: Patients are recruited by health care professionals of the family medicine unit and are thereafter randomized to one of four intervention groups: 1) standard medical care (control), 2) improved diet (DASH diet), 3) physical activity, or 4) both improved diet and physical activity. Patients are evaluated (pre, mid and post intervention), monitored, and educated by the interdisciplinary health care team that includes a physician, a kinesiologist, a nutritionist and a nurse, depending on the intervention group. T-tests and descriptive statistics were used to analyse data. This study will document the efficacy of a primary care lifestyle intervention program on cardiometabolic and hypertension risk factors.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | December 23, 2016 |
| Est. primary completion date | December 23, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 90 Years |
| Eligibility | Inclusion Criteria: - =18 years of age - Sedentary (7-day measured steps/day and self-report) - Arterial hypertensive (based on 24-h ambulatory blood pressure measurements [ABPM]) Exclusion Criteria: - secondary hypertension - diabetes - dyslipidemia - cardiovascular diseases with complications - smoker |
| Country | Name | City | State |
|---|---|---|---|
| Canada | GMF-UMF Laval-Québec | Québec |
| Lead Sponsor | Collaborator |
|---|---|
| Laval University | CSSS-VC, Fondation IUCPQ, GMF-UMF Laval-Québec |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Systolic and diastolic blood pressure | 6 months |
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