Overweight or ObesityMeDiPANCT04155112
Hypocaloric Mediterranean Diet or Physical Activity to Lower Cardiometabolic Risk
A study testing Physical activity and Hypocaloric Mediterranean diet in people with Overweight or Obesity and Obesity, Abdominal, run by Oslo University Hospital at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Overweight or Obesity, Obesity, Abdominal, Hypertension
- What is being tested?
- Physical activity and Hypocaloric Mediterranean diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteNorway
- Study dates
- 21 Apr 2023to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital, Aker
Oslo, 0424
Kari Anne Sveen, MD, PhD, kasvee@ous-hf.no
About this study
Official title: Hypocaloric Mediterranean Diet or Physical Activity to Lower Cardiometabolic Risk in Vulnerable Populations: the MeDiPA Study
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.
- Conditions
- Overweight or Obesity, Obesity, Abdominal, Hypertension
- Being tested
- Physical activity, Hypocaloric Mediterranean diet
- Keywords
- Hypertension, Lifestyle, Mediterranean diet, Physical activity, Weight loss
- Medical subject headings
- Overweight, Obesity, Obesity, Abdominal, Hypertension, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
Also called PA
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).
Hypocaloric Mediterranean dietBehavioural
Also called MeDi
Energy deficit to reach 5-10% weight loss within 6 months, based on the Mediterranean diet pattern.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity (PA) | Experimental | 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. Receives: Behavioral: Physical activity |
| Hypocaloric Mediterranean diet (MeDi) | Experimental | 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. Receives: Behavioral: Hypocaloric Mediterranean diet |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: baseline to 6 months
Secondary outcomes (5)
Change in other measures of blood pressure, within and among subjects, after 6 and 12 months.
Blood pressure will be measured with 24-hour ambulatory blood pressure monitors and in-office. Other measures of blood pressure include daytime blood pressure, nighttime blood pressure, and office systolic and diastolic blood pressure.
Change = (6 or 12 month measurement - baseline measurement)
Measured: Baseline to 6 months, baseline to 12 months
Change in body composition, within and among subjects, after 6 months.
Office measures of body composition will include weight, waist and hip circumferences, BMI, waist-to-hip ratio, and bioimpedance analysis (BIA). Additional measures of body composition will be acquired via Dual-energy X-ray absorptiometry (DXA), including fat mass, fat-free body mass, visceral adipose tissue, subcutaneous adipose tissue, and bone mineral content and density.
Change = (6 month measurement - baseline measurement)
Measured: Baseline to 6 months
Change in markers of cardiometabolic risk, within and among subjects, after 6 and 12 months.
Cardiometabolic risk factors (including measures of glucose regulation, blood lipids, NORRISK 2 score, metabolic syndrome) will be measured via blood samples and additional clinical parameters.
Change = (6 or 12 month measurement - baseline measurement)
Measured: Baseline to 6 months, baseline to 12 months
Change in inflammation markers, within and among subjects, after 6 and 12 months.
Inflammation markers will be measured via blood tests (including CRP and differential leucocyte count).
Change = (6 or 12 month measurement - baseline measurement)
Measured: Baseline to 6 months, baseline to 12 months
Change in safety outcomes, within and among subjects, after 6 and 12 months.
Safety outcomes will be measured via blood tests (including hematology, kidney, liver, and thyroid markers).
Change = (6 or 12 month measurement - baseline measurement)
Measured: Baseline to 6 months, baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start21 Apr 2023
- Primary completionOct 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight or ObesityStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The National Association for Public Health, Norway
- Responsible party
- Principal investigator, Kari Anne Sveen, Oslo University Hospital
- Investigators
- Kari Anne Sveen, MD, PhD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155112
- Sponsor's protocol ID
- 2019/696
- Acronym
- MeDiPA
- Status last verified
- May 2023
- First submitted
- 23 Oct 2019
- Last updated
- 9 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42471008
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypocaloric Mediterranean Diet or Physical Activity to Lower Cardiometabolic Risk in Vulnerable Populations: the MeDiPA Study
- ClinicalTrials.gov ID
- NCT04155112
- Acronym / sponsor ID
- MeDiPA / 2019/696
- Conditions
- Overweight or Obesity, Obesity, Abdominal, Hypertension
- Keywords
- Hypertension, Lifestyle, Mediterranean diet, Physical activity, Weight loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- The National Association for Public Health, Norway
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical activity (PA) | Experimental | Behavioral: Physical activityFor 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. |
| Hypocaloric Mediterranean diet (MeDi) | Experimental | Behavioral: Hypocaloric Mediterranean dietFor 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityAlso: PAIncreased 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). | Behavioural | Physical activity (PA) |
| Hypocaloric Mediterranean dietAlso: MeDiEnergy deficit to reach 5-10% weight loss within 6 months, based on the Mediterranean diet pattern. | Behavioural | Hypocaloric Mediterranean diet (MeDi) |
Primary outcome
Change in 24-hour ambulatory SBP among subjects, after 6 months.
Time frame: Baseline to 6 months
24-hour ambulatory blood pressure will be measured with a device that allows free-living. Change = (6 month measurement - baseline measurement).
Change in 24-hour ambulatory DBP among subjects, after 6 months.
Time frame: baseline to 6 months
24-hour ambulatory blood pressure will be measured with a device that allows free-living. Change = (6 month measurement - baseline measurement).
5 secondary outcomes
Change in other measures of blood pressure, within and among subjects, after 6 and 12 months.
Time frame: Baseline to 6 months, baseline to 12 months
Change in body composition, within and among subjects, after 6 months.
Time frame: Baseline to 6 months
Change in markers of cardiometabolic risk, within and among subjects, after 6 and 12 months.
Time frame: Baseline to 6 months, baseline to 12 months
Change in inflammation markers, within and among subjects, after 6 and 12 months.
Time frame: Baseline to 6 months, baseline to 12 months
Change in safety outcomes, within and among subjects, after 6 and 12 months.
Time frame: Baseline to 6 months, baseline to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Derived from this study: PubMed 42471008de 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.
- Individual participant dataSharing planned: No
Related trials for Overweight or Obesity
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 3
Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)
Obesity or Overweight
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
RecruitingPhase 2
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
Overweight or Obesity
Active, not recruitingPhase 3
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Diabetes Mellitus, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kari Anne Sveen, MD, PhD study chair
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity and Hypocaloric Mediterranean diet in people with Overweight or Obesity and Obesity, Abdominal, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kari Anne Sveen, MD, PhD (0047 915 02 770, kasvee@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24-hour ambulatory SBP among subjects, after 6 months. (time frame: Baseline to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04155112, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.