Effects of a Mediterranean diet or physical activity on blood pressure in overweight individuals
Hypocaloric Mediterranean Diet or Physical Activity to Lower Cardiometabolic Risk in Vulnerable Populations: the MeDiPA Study
This study is testing whether a Mediterranean diet or increased physical activity can help overweight people who are already on blood pressure medication lower their blood pressure more effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 1 site (Oslo) |
| Trial ID | NCT04155112 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to evaluate the impact of a hypocaloric Mediterranean diet and physical activity on lowering blood pressure in participants who are taking at least two antihypertensive medications but are not achieving their treatment goals. The study involves three groups: one following the Mediterranean diet, another engaging in physical activity, and a control group receiving usual care. Participants will be monitored over a 6-month intervention period, with follow-up assessments at 3, 6, and 12 months to measure changes in blood pressure and other cardiometabolic markers. The primary outcome is the change in mean 24-hour ambulatory blood pressure after the intervention.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 18 to 70 who are overweight, taking multiple antihypertensive medications, and have not achieved their blood pressure goals.
Not a fit: Patients with severe hypertension, diabetes type 1, or significant cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective lifestyle interventions to help patients better manage their blood pressure and reduce cardiometabolic risks.
How similar studies have performed: Previous studies have shown that lifestyle interventions like diet and physical activity can significantly improve blood pressure control, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women * 18 - 70 years * Taking ≥ 2 antihypertensive drugs (includes combination therapy) * Office SBP ≥ 140mmHg and/or DBP ≥ 90mmHg on two occasions * BMI 25 - 40 kg/m2 * Waist circumference ≥ 88 cm (women) or ≥ 102 cm (men) * Sedentary lifestyle (\< 150 minutes/week of moderate intensity physical activity) * Weight stable (± 5 kg in the last 6 months) * Not on a weight loss diet * Willing to comply to an intervention of either a hypocaloric Mediterranean diet or physical activity (or control) for 6 months Exclusion Criteria: * Unable to provide informed consent * Pregnant or lactating * Office BP ≥ 160/100 mmHg * Diabetes mellitus type 1 * History of cardiovascular disease (including uncompensated heart failure, recent infarction or stroke in the last 6 months, severe arrhythmia, heart failure or unstable angina pectoris) * Chronic kidney disease stages 4 or 5 * Cancer in the last 5 years * Changes in concurrent medication (anti-hypertensives, anti-diabetics, lipid-lowering drugs) in the last 3 months * Regular use of oral corticosteroids in excess of 5 mg prednisolone (or equivalent) during the last month * Use of GLP-1 analogues for \< 1 year * Drug or alcohol abuse * Eating disorders or severe dietary restrictions * Impediments to physical activity at recommended levels due to musculoskeletal and other conditions.
Where this trial is running
Oslo
- Oslo University Hospital, Aker — Oslo, Norway (Recruiting)
Study contacts
- Study coordinator: Kari Anne Sveen, MD, PhD
- Email: kasvee@ous-hf.no
- Phone: 0047 915 02 770
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.