Lifestyle Intervention for Treating Systemic Hypertension in Primary Care Setting

NCT ID: NCT02492035

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-12-23

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Physical activity

Tailoring intervention with kinesiologist

Group Type EXPERIMENTAL

Lifestyle intervention

Intervention Type BEHAVIORAL

Diet

Tailoring intervention with nutritionist

Group Type EXPERIMENTAL

Lifestyle intervention

Intervention Type BEHAVIORAL

Physical activity and diet

Tailoring intervention with kinesiologist and nutritionist

Group Type EXPERIMENTAL

Lifestyle intervention

Intervention Type BEHAVIORAL

Standard medical care

Follow with family doctor as usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lifestyle intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation IUCPQ

OTHER

Sponsor Role collaborator

CSSS-VC

UNKNOWN

Sponsor Role collaborator

GMF-UMF Laval-Québec

UNKNOWN

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role lead

Responsible Party

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Caroline

MD,PhD, clinical researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Caroline Rhéaume, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

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GMF-UMF Laval-Québec

Québec, , Canada

Site Status

Countries

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Canada

Other Identifiers

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20805

Identifier Type: -

Identifier Source: org_study_id

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