NCT04155112

Hypocaloric Mediterranean Diet or Physical Activity to Lower Cardiometabolic Risk

Hypocaloric Mediterranean Diet or Physical Activity to Lower Cardiometabolic Risk in Vulnerable Populations: the MeDiPA Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

• Overweight or Obesity
• Obesity, Abdominal
• Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-04-21
• Primary completion: 2024-10-01
• Completion: 2025-09-01
• First posted: 2019-11-07
• Last updated: 2023-05-09

Locations

1 site across 1 country: Norway