Hypertension / Metabolic Syndrome / Cardiometabolic Disease · Journal article
Blood Pressure · August 6, 2026
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This is a design paper for the MeDiPA trial, a small three-arm RCT comparing hypocaloric Mediterranean diet, increased physical activity, and control in 66 patients with uncontrolled hypertension despite ≥2 antihypertensives. Baseline characteristics are reported; primary efficacy outcomes (24-h ambulatory BP change at 6 months) are not yet available.
Randomised controlled trial with three parallel arms. Adults with uncontrolled hypertension on pharmacological treatment (≥2 antihypertensives), BMI 25–40 kg/m², and abdominal obesity. Exclusions: BP ≥160/100 mmHg, type 1 diabetes, recent cardiovascular disease, chronic kidney disease.. Intervention: Hypocaloric Mediterranean-style diet (n=21) or increased physical activity (n=22), for 6 months.. Compared with: Control group (n=23) receiving standard care for 6 months.. n = 66. Not explicitly stated; 85% of participants reported as Norwegian, suggesting primary enrolment in Norway..
66 participants enrolled: 21 diet, 22 physical activity, 23 control 56% women; mean age 59 (8) years; 85% Norwegian Mean baseline office BP 137 (15)/90 (8) mmHg with 61% having BP ≥ 140/90 mmHg
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This design paper does not provide evidence on treatment efficacy. Clinicians should await publication of the primary outcome results (24-h ambulatory BP at 6 months) to learn whether lifestyle modification combined with pharmacotherapy improves BP control in resistant hypertension.
This is a design paper reporting baseline characteristics of a small RCT (n=66) not yet reporting efficacy outcomes; the trial will generate evidence but no treatment effect data are presented.
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This design paper does not provide evidence on treatment efficacy. Clinicians should await publication of the primary outcome results (24-h ambulatory BP at 6 months) to learn whether lifestyle modification combined with pharmacotherapy improves BP control in resistant hypertension.
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Background. Many patients pharmacologically treated for hypertension do not reach blood pressure (BP) treatment targets. In Europe, a target of BP < 130/80 mmHg has recently been recommended. Presently, the effect of combining pharmacological approaches and lifestyle changes is unclear. The Hypocaloric Mediterranean Diet or Physical Activity (MeDiPA) randomised controlled trial aims at investigating the effects of lifestyle modifications in patients with uncontrolled hypertension taking antihypertensives. Here, we present the MeDiPA design and baseline population characteristics.Methods. We included participants with office BP ≥ 130/80 mmHg on two occasions, taking at least two antihypertensives, with body mass index (BMI) 25-40 kg/m2 and waist circumference ≥88 cm (women)/≥102 cm (men). We excluded participants with BP ≥ 160/100 mmHg, type 1 diabetes, recent cardiovascular disease or chronic kidney disease. Participants were randomised to a hypocaloric Mediterranean-style diet, increased physical activity or control, for 6 months. The main outcome is changes in 24-h ambulatory BP after 6 months. Exploratory outcomes include changes in metabolic parameters and quality of life.Results. Sixty-six participants were included (56% women): 21, 22 and 23 in the diet, physical activity and control groups, respectively. Mean (standard deviation) age was 59 (8) years, 85% of participants were Norwegian and 83% had higher education. Mean BMI was 32.0 (4.5) kg/m2 and waist circumference was 106.3 (11.8) cm (women)/113.3 (8.6) cm (men). Mean BP was 137 (15)/90 (8) mmHg and 61% of participants had BP ≥ 140/90 mmHg.Conclusion. This trial will improve our understanding of how lifestyle modifications modulate BP in pharmacologically treated patients with uncontrolled hypertension.Trial registration NCT04155112; first submitted 2019-10-23.
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