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Hypocaloric Mediterranean Diet or Physical Activity to Lower Cardiometabolic Risk

NCT04155112 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-05-09

No results posted yet for this study

Summary

The purpose of this randomized controlled trial is to test the effects of a hypocaloric Mediterranean diet or of physical activity in participants who take at least 2 antihypertensive drugs but do not reach blood pressure treatment goal.

This study is a randomized, controlled, single-center, parallel group trial with three arms: hypocaloric Mediterranean diet (MeDi), physical activity (PA), or control. The control group will receive usual care (no intervention). This study will not be blinded.

The interventions will last 6 months, while the study follow-up will last 12 months. Four study visits will take place: baseline, at 3 months, at 6 months, at 12 months. The primary outcome is change in mean 24-hour ambulatory systolic blood pressure and diastolic blood pressure among groups after 6 months of intervention. Secondary and exploratory outcomes include change in other measures of blood pressure, body composition, other markers of cardiometabolic disease, inflammation markers, safety outcomes, and quality of life, among others.

Conditions

Interventions

BEHAVIORAL

Physical activity

Increased physical activity to the minimum recommended by health authorities (≥ 150 min of moderate intensity or ≥ 75 min of vigorous intensity aerobic PA (or an equivalent combination) and ≥ 2 days of resistance exercise a week).

BEHAVIORAL

Hypocaloric Mediterranean diet

Energy deficit to reach 5-10% weight loss within 6 months, based on the Mediterranean diet pattern.

Sponsors & Collaborators

  • The National Association for Public Health, Norway

    collaborator OTHER_GOV

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Kari Anne Sveen, MD, PhD · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-21
Primary Completion
2024-10-31
Completion
2025-09-30

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04155112 on ClinicalTrials.gov