NCT04155112|Unknown
Hypocaloric Mediterranean Diet or Physical Activity to Lower Cardiometabolic Risk
MeDiPA
Loading search results
MeDiPA
Sponsor study identifier
interventional
90
1 country
1
Study Start
April 21, 2023
Actual (reported)Primary Completion
October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 23, 2019
Actual (reported)November 7, 2019
Actual (reported)April 21, 2023
Actual (reported)October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change in 24-hour ambulatory SBP among subjects, after 6 months.
24-hour ambulatory blood pressure will be measured with a device that allows free-living. Change = (6 month measurement - baseline measurement).
Baseline to 6 months
Change in 24-hour ambulatory DBP among subjects, after 6 months.
24-hour ambulatory blood pressure will be measured with a device that allows free-living. Change = (6 month measurement - baseline measurement).
baseline to 6 months
Change in other measures of blood pressure, within and among subjects, after 6 and 12 months.
Baseline to 6 months, baseline to 12 months
For 6 months, the participants will be recommended to increase physical activity to ≥ 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. The participants will take part in supervised group classes, twice per week. Each participant will receive a heart rate monitor to bring home and to use while reporting activity via a physical activity diary.
For 6 months, the participants will be recommended to consume a diet for 5-10% body weight loss. This diet will be based on the Mediterranean diet pattern. For the 6 months of the intervention, the participants will weigh themselves weekly and report their progress to the investigator. Adaptations to the diet will be made to ensure the goal of 5-10% weight loss is achieved. Each participant will receive a scale to bring home and to use while reporting weight loss.
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).
Energy deficit to reach 5-10% weight loss within 6 months, based on the Mediterranean diet pattern.
Oslo University Hospital, Aker
Oslo, 0424, Norway
de Sousa ARS, Klemsdal TO, Ghiasvand R, Svendsen M, Birkeland KI, Sveen KA. Lifestyle modifications in individuals with blood pressure beyond treatment target despite pharmacological treatment: design and baseline characteristics of the MeDiPA randomised controlled trial. Blood Press. 2026 Dec;35(1):2705014. doi: 10.1080/08037051.2026.2705014. Epub 2026 Aug 6.
Kari Anne Sveen, MD, PhD
Oslo University Hospital
First Submitted
October 23, 2019
First Posted
November 7, 2019
Study Start
April 21, 2023
Actual (reported)Primary Completion
October 2024
Estimated (date passed)The Inland Norway Healthy Life Center Study
Change in body composition, within and among subjects, after 6 months.
Baseline to 6 months
Change in markers of cardiometabolic risk, within and among subjects, after 6 and 12 months.
Baseline to 6 months, baseline to 12 months
Change in inflammation markers, within and among subjects, after 6 and 12 months.
Baseline to 6 months, baseline to 12 months
Change in safety outcomes, within and among subjects, after 6 and 12 months.
Baseline to 6 months, baseline to 12 months
Change in quality of life, within and among subjects, after 3, 6 and 12 months.
Baseline to 6 months, baseline to 12 months
At baseline, participants will receive usual care, which consists of general information regarding the importance of lifestyle for BP. This information will not be reinforced throughout the study duration.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 9, 2023
Record last verified: 2023-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: