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OpenTrials
Completed

NCT Number: NCT02492035

Lifestyle Intervention for Treating Systemic Hypertension in Primary Care Setting

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GMF-UMF Laval-Québec

Québec, G1V0B7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Intervention

Behavioral

Primary outcomes

  1. Systolic and diastolic blood pressure

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • CSSS-VC
  • Fondation IUCPQ
  • GMF-UMF Laval-Québec

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 8, 2015
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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