Many patients receiving pharmacological treatment for hypertension do not reach current guideline blood pressure (BP) targets. Recent European guidance has recommended a target of BP < 130/80 mmHg, but the additional benefit of combining antihypertensive medication with structured lifestyle interventions remains uncertain. The Hypocaloric Mediterranean Diet or Physical Activity (MeDiPA) randomised controlled trial was designed to evaluate whether targeted lifestyle modification can reduce BP in people who remain above treatment targets despite taking antihypertensive drugs.
MeDiPA is a three-arm, parallel-group randomised controlled trial with a 6-month intervention period and follow-up visits planned at baseline, 3, 6 and 12 months. Participants were randomised to one of three arms:
The interventions are intended to assess the effects of dietary weight-loss and increased physical activity on blood pressure and related cardiometabolic outcomes in a population already receiving pharmacological treatment for hypertension.
Inclusion criteria reported in the trial were:
Key exclusion criteria were:
These criteria were chosen to target participants with persistent, moderate hypertension despite pharmacological therapy, who also have overweight/obesity and central adiposity.
A total of 66 participants were enrolled and randomised into the three groups: 21 allocated to the diet intervention, 22 to the physical activity intervention and 23 to the control group. Randomisation procedures are reported in the trial design; group sizes reflect the enrolled sample at baseline.
The primary outcome is the change in 24-h ambulatory blood pressure after 6 months of intervention. Ambulatory monitoring provides a more complete assessment of BP control over a full day compared with office measurements.
Secondary and exploratory outcomes include changes in metabolic parameters and measures of quality of life. Participants undergo study visits at baseline, 3, 6 and 12 months to collect outcome data and monitor changes over time.
Sixty-six participants were included in the trial. Key baseline characteristics reported are:
These baseline data indicate that the enrolled cohort is middle-aged, predominately Norwegian, largely highly educated, and at increased cardiometabolic risk due to obesity and elevated BP despite multiple antihypertensive agents.
The principal analysis will compare 24-h ambulatory BP changes after 6 months across the three groups. Exploratory analyses will examine metabolic outcomes and quality of life. The trial is registered on ClinicalTrials.gov (NCT04155112), with first submission dated 2019-10-23.
MeDiPA is positioned to clarify whether targeted lifestyle interventions—weight-loss through a hypocaloric Mediterranean diet or increased physical activity—provide additional BP reduction in patients already treated with at least two antihypertensive medications but who remain above recommended targets. By using 24-h ambulatory BP as the primary endpoint and enrolling a population with obesity and central adiposity, the trial specifically addresses the question of additive benefits of lifestyle on ambulatory BP control and related cardiometabolic measures in a high-risk, treated population.
Note: All details above are taken from the published trial design and baseline report. No outcome data from the 6-month follow-up are reported in the source abstract.