Lifestyle Intervention for Treating Systemic Hypertension in Primary Care Setting

October 14, 2020 updated by: Caroline, Laval University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Québec, Canada, G1V0B7
        • GMF-UMF Laval-Québec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical activity
Tailoring intervention with kinesiologist
Behavioral: Lifestyle intervention
Experimental: Diet
Tailoring intervention with nutritionist
Behavioral: Lifestyle intervention
Experimental: Physical activity and diet
Tailoring intervention with kinesiologist and nutritionist
Behavioral: Lifestyle intervention
No Intervention: Standard medical care
Follow with family doctor as usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Systolic and diastolic blood pressure
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

Fondation IUCPQ
CSSS-VC
GMF-UMF Laval-Québec

Investigators

  • Principal Investigator: Caroline Rhéaume, MD,PhD, Laval University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

December 23, 2016

Study Completion (Actual)

December 23, 2016

Study Registration Dates

First Submitted

June 3, 2015

First Submitted That Met QC Criteria

July 2, 2015

First Posted (Estimate)

July 8, 2015

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 14, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20805

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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