Lifestyle modifications in individuals with blood pressure beyond treatment target despite pharmacological treatment: design and baseline characteristics of the MeDiPA randomized controlled trial.

Authors

Ana R S de Sousa, Tor Ole Klemsdal, Reza Ghiasvand, Mette Svendsen, Kåre I Birkeland, Kari Anne Sveen

Published in

Blood pressure. Pages 1-20. Jul 18, 2026. Epub Jul 18, 2026.

Abstract

A large proportion of patients pharmacologically treated for hypertension do not reach blood pressure (BP) treatment targets. In Europe, a stricter target of BP < 130/80 mmHg has recently been recommended. Presently, it is unknown whether the combination of pharmacological approaches and lifestyle changes can help patients achieve these new targets. The Hypocaloric Mediterranean Diet or Physical Activity (MeDiPA) randomized 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.
We included participants with office BP ≥ 130/80 mmHg on two occasions, taking minimum two antihypertensives, with 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 history of cardiovascular disease, or chronic kidney disease. Participants were randomized to a hypocaloric Mediterranean-style diet, increased physical activity, or control, for six months. Visits took place at baseline, after three, six, and 12 months. The main outcome is changes in 24-hour ambulatory BP after six months. Exploratory outcomes include changes in metabolic parameters and quality of life.
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. In general, participants fulfilled three metabolic syndrome criteria.
The MeDiPA study included participants at high cardiometabolic risk. This trial will add to the knowledge concerning how lifestyle modifications modulate BP in pharmacologically-treated patients with uncontrolled hypertension.
NCT04155112, first submitted 2019-10-23.

PMID:
42471008
Bibliographic data and abstract were imported from PubMed on 19 Jul 2026.

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