Lifestyle Intervention for Treating Systemic Hypertension in Primary Care Setting

NCT02492035 | Completed

• 1 other identifier: 20805
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

Hypertension; lifestyle; clinical trials; primary care setting

Outcome Measures

Primary Outcomes (1)

• Systolic and diastolic blood pressure

  6 months

Study Arms (4)

Physical activity

EXPERIMENTAL

Tailoring intervention with kinesiologist

Behavioral: Lifestyle intervention

Diet

EXPERIMENTAL

Tailoring intervention with nutritionist

Behavioral: Lifestyle intervention

Physical activity and diet

EXPERIMENTAL

Tailoring intervention with kinesiologist and nutritionist

Behavioral: Lifestyle intervention

Standard medical care

NO INTERVENTION

Follow with family doctor as usual care.

Interventions

Lifestyle intervention BEHAVIORAL

Diet; Physical activity; Physical activity and diet

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• Sedentary (7-day measured steps/day and self-report)
• Arterial hypertensive (based on 24-h ambulatory blood pressure measurements \[ABPM\])

You may not qualify if:

• secondary hypertension
• diabetes
• dyslipidemia
• cardiovascular diseases with complications
• smoker

Sponsors & Collaborators

• Laval University: lead
• Fondation IUCPQ: collaborator
• CSSS-VC: collaborator
• GMF-UMF Laval-Québec: collaborator

Study Sites (1)

GMF-UMF Laval-Québec

Québec, G1V0B7, Canada

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Caroline Rhéaume, MD,PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD, clinical researcher

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: July 8, 2015
• Study Start: February 1, 2013
• Primary Completion: December 23, 2016
• Study Completion: December 23, 2016
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

CA (1)