PostpartumMedMomNCT07038681
Mediterranean Diet Intervention for Maternal Postpartum
A study testing Mediterranean Diet Intervention Group in people with Postpartum and Cardiometabolic Factors, run by Universidade do Porto at 1 site in Portugal.
Trial summary
The increasing prevalence of obesity during women's reproductive years highlights the need for effective strategies to improve nutritional literacy as a preventive approach to adverse postnatal outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum, Cardiometabolic Factors, Cardiac Reverse Remodeling
- What is being tested?
- Mediterranean Diet Intervention Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 sitePortugal
- Study dates
- 31 May 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult female (>18 years old)
- Obesity
- Chronic arterial hypertension
- Type 2 diabetes
- Gestational hypertension
- Gestational diabetes
Who cannot join
- Preexisting cardiomyopathy;
- Renal disease;
- Chronic obstructive airway disease;
- Active systemic infection;
- Genetic syndromes;
- Type 1 Diabetes mellitus
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Unidade Local de Saúde de São João
Porto, Viana do Castelo District, 4200-319
Juliana Morais, Master, 225512100 + 962711106 ext. +351, ju_morais17@hotmail.com
About this study
Official title: Mediterranean Diet Intervention for Maternal Postpartum Cardiometabolic and Microbiome Health (MedMom Study): a Randomized Trial
The increasing prevalence of obesity during women's reproductive years highlights the need for effective strategies to improve nutritional literacy as a preventive approach to adverse postnatal outcomes.
This study outlines a protocol for a pilot randomized controlled trial assessing the potential of nutritional education sessions promoting the Mediterranean Diet (MedDiet) to improve adherence to this diet and evaluate its effects on cardiometabolic outcomes, namely on cardiac reverse remodeling, glycemic and blood pressure control, as well as on preconception weight recovery and changes in the fecal microbiota composition in pregnant women with obesity, hypertension, and/or diabetes.
Secondarily, this study aims to evaluate how this dietary intervention indirectly interferes with infants' exclusive breastfeeding and the introduction of complementary feeding. It includes a face-to-face session using an eye-catching 13-page manual, followed by five monthly newsletters sent by e-mail. Participants will be monitored at one, six, and twelve months postpartum to evaluate the intervention's effectiveness. Findings from this study will contribute to the development of an evidence-based nutritional education tool designed to improve maternal health outcomes, with potential applicability for both health professionals and pregnant and postpartum women.
- Being tested
- Mediterranean Diet Intervention Group, Control Group (Standard Hospital Dietary Care)
- Keywords
- Mediterranean Diet, Postpartum, Pregnancy, Cardiac Reverse Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean Diet Intervention GroupOther
Also called Diet group
In the same way as the control group, the intervention group receives standard nutritional care from the hospital nutritionist, since all the pregnant women have at least one of the following risk factors: obesity, diabetes or hypertension, nutritional - standard-care procedure in the Portuguese National Health System.
Control Group (Standard Hospital Dietary Care)Other
The control group will receive standard care from the nutritionist in the hospital.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (Standard Hospital Dietary Care) | Placebo comparator | Since all the pregnant women in this study have at least one of the following risk factors: obesity, diabetes or hypertension, nutritional follow-up is a standard-care procedure in the Portuguese National Health System, therefore the control group receive usual care from the nutritionist in the hospital. Receives: Other: Control Group (Standard Hospital Dietary Care) |
| Mediterranean Diet Intervention Group | Experimental | In addition to the standard-care follow-up in the Portuguese National Health System, the intervention group will have additionally three approaches within the intervention: i) one face-to-face appointment lasting 10 to 15 minutes conducted by a registered dietitian (3rd trimester: 30 - 35 gestational weeks); ii) a 13-page manual that accompanies the dietary education session, which is provided to each participant; and iii) five monthly newsletters sent via e-mail from two weeks after childbirth until the fifth month postpartum. Receives: Other: Mediterranean Diet Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Mediterranean Diet Adherence
To assess the effect of the dietary education counseling focused Mediterranean Diet promotion (intervention group) vs nutritional standard-care of the. Portuguese National Health System (Control Group: Standard Hospital Dietary Care)) on the percentage change of the Mediterranean Diet Adherence Screener (MEDAS) score.
The MEDAS score ranges from 0 to 14, with higher scores indicating greater adherence to the Mediterranean Diet. Scores are commonly classified as follows:
- Low adherence: < 7
- Moderate adherence: 7-9
- High adherence: ≥ 10
Measured: Visit 1 (3rd trimester - 30-25 gestational weeks), visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum)
Secondary outcomes (7)
Left Ventricular Reverse Remodeling Assessed by Echocardiography (Cardiac reserve remodeling)
To assess the effect of dietary education counseling focused on Mediterranean Diet promotion (intervention group) vs control group on cardiac reverse remodeling, evaluated through echocardiographic measurements of cardiac structure and function during pregnancy and postpartum.
Cardiac reverse remodeling will be assessed as the change (Δ) in left ventricular (LV) mass between the third trimester of pregnancy and 6 months postpartum.
Conventional transthoracic echocardiography will be performed using a 3 MHz phased-array probe (ACUSON SC2000 PRIME) by a single operator. Measurements will be obtained from standard parasternal and apical views, according to the European Society of Cardiology recommendations.
Left ventricular mass (g) will be estimated using the following formula:
LV mass = 0.8 × {1.04 × [(LVEDD + PWTd + IVSd)³ - (LVEDD)³]} + 0.6 where: LVEDD = LV end-diastolic diameter PWTdP = posterior wall thickness in diastole IVSd = interventricular septal thickness in diastole
Measured: Visit 1 (3rd trimester - 30-25 gestational weeks), visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).
Gut Microbiota
To assess the effect of the dietary education counseling focused Mediterranean Diet promotion (intervention group) vs nutritional standard-care of the Portuguese National Health System (control group) on the percentage change of the following measures relative to the baseline measures.
Measured: Visit 1 (3rd trimester - 30-25 gestational weeks), visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).
Systolic blood pressure
To assess the effect of the dietary education counseling focused Mediterranean Diet promotion (intervention group) vs nutritional standard-care of the Portuguese National Health System (control group) on the percentage of the following measures relative to the baseline measures.
Measured: Visit 1 (3rd trimester - 30-25 gestational weeks), visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).
Diastolic blood pressure
To assess the effect of the dietary education counseling focused Mediterranean Diet promotion (intervention group) vs nutritional standard-care of the Portuguese National Health System (control group) on the percentage of the following measures relative to the baseline measures.
Measured: Visit 1 (3rd trimester - 30-25 gestational weeks), visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).
Recovery of gestational weight gain
To assess the effect of the dietary education counseling focused Mediterranean Diet promotion (intervention group) vs nutritional standard-care of the Portuguese National Health System (control group) on recovery of the gestational weight gain.
Measured: Visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).
Glucose
To assess the effect of the dietary education counseling focused Mediterranean Diet promotion (intervention group) vs nutritional standard-care of the Portuguese National Health System (control group) on the percentage change of the following measures relative to the baseline measures.
Measured: Visit 1 (3rd trimester - 30-25 gestational weeks), visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).
Haemoglobin A1c
To assess the effect of the dietary education counseling focused Mediterranean Diet promotion (intervention group) vs nutritional standard-care of the Portuguese National Health System (control group) on the percentage change of the following measures relative to the baseline measures.
Measured: Visit 1 (3rd trimester - 30-25 gestational weeks), visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start31 May 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostpartumStudies of the same condition, open and under way.
- 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
- Model description
- Prospective, randomized, two-treatment, one-period, parallel trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Inês Falcão Pires, PhD, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038681
- Sponsor's protocol ID
- MedMom
- Acronym
- MedMom
- Status last verified
- May 2025
- First submitted
- 5 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediterranean Diet Intervention for Maternal Postpartum Cardiometabolic and Microbiome Health (MedMom Study): a Randomized Trial
- ClinicalTrials.gov ID
- NCT07038681
- Acronym / sponsor ID
- MedMom / MedMom
- Keywords
- Mediterranean Diet, Postpartum, Pregnancy, Cardiac Reverse Remodeling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 31 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Jun 2025 (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 increasing prevalence of obesity during women's reproductive years highlights the need for effective strategies to improve nutritional literacy as a preventive approach to adverse postnatal outcomes.
This study outlines a protocol for a pilot randomized controlled trial assessing the potential of nutritional education sessions promoting the Mediterranean Diet (MedDiet) to improve adherence to this diet and evaluate its effects on cardiometabolic outcomes, namely on cardiac reverse remodeling, glycemic and blood pressure control, as well as on preconception weight recovery and changes in the fecal microbiota composition in pregnant women with obesity, hypertension, and/or diabetes.
Secondarily, this study aims to evaluate how this dietary intervention indirectly interferes with infants' exclusive breastfeeding and the introduction of complementary feeding. It includes a face-to-face session using an eye-catching 13-page manual, followed by five monthly newsletters sent by e-mail. Participants will be monitored at one, six, and twelve months postpartum to evaluate the intervention's effectiveness. Findings from this study will contribute to the development of an evidence-based nutritional education tool designed to improve maternal health outcomes, with potential applicability for both health professionals and pregnant and postpartum women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, randomized, two-treatment, one-period, parallel trial
| Arm | Type | Receives |
|---|---|---|
| Control Group (Standard Hospital Dietary Care) | Placebo comparator | Other: Control Group (Standard Hospital Dietary Care)Since all the pregnant women in this study have at least one of the following risk factors: obesity, diabetes or hypertension, nutritional follow-up is a standard-care procedure in the Portuguese National Health System, therefore the control group receive usual care from the nutritionist in the hospital. |
| Mediterranean Diet Intervention Group | Experimental | Other: Mediterranean Diet Intervention GroupIn addition to the standard-care follow-up in the Portuguese National Health System, the intervention group will have additionally three approaches within the intervention: i) one face-to-face appointment lasting 10 to 15 minutes conducted by a registered dietitian (3rd trimester: 30 - 35 gestational weeks); ii) a 13-page manual that accompanies the dietary education session, which is provided to each participant; and iii) five monthly newsletters sent via e-mail from two weeks after childbirth until the fifth month postpartum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult female (>18 years old)
- Obesity
- Chronic arterial hypertension
- Type 2 diabetes
- Gestational hypertension
Key exclusion criteria (6 listed)
- Preexisting cardiomyopathy;
- Renal disease;
- Chronic obstructive airway disease;
- Active systemic infection;
- Genetic syndromes;
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 |
|---|---|---|
| Mediterranean Diet Intervention GroupAlso: Diet groupIn the same way as the control group, the intervention group receives standard nutritional care from the hospital nutritionist, since all the pregnant women have at least one of the following risk factors: obesity, diabetes or hypertension, nutritional - standard-care procedure in the Portuguese National Health System. | Other | Mediterranean Diet Intervention Group |
| Control Group (Standard Hospital Dietary Care)The control group will receive standard care from the nutritionist in the hospital. | Other | Control Group (Standard Hospital Dietary Care) |
Primary outcome
Maternal Mediterranean Diet Adherence
Time frame: Visit 1 (3rd trimester - 30-25 gestational weeks), visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum)
To assess the effect of the dietary education counseling focused Mediterranean Diet promotion (intervention group) vs nutritional standard-care of the. Portuguese National Health System (Control Group: Standard Hospital Dietary Care)) on the percentage change of the Mediterranean Diet Adherence Screener (MEDAS) score. The MEDAS score ranges from 0 to 14, with higher scores indicating greater adherence to the Mediterranean Diet. Scores are commonly classified as follows: * Low adherence: < 7 * Moderate adherence: 7-9 * High adherence: ≥ 10
7 secondary outcomes
Left Ventricular Reverse Remodeling Assessed by Echocardiography (Cardiac reserve remodeling)
Time frame: Visit 1 (3rd trimester - 30-25 gestational weeks), visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).
Gut Microbiota
Time frame: Visit 1 (3rd trimester - 30-25 gestational weeks), visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).
Systolic blood pressure
Time frame: Visit 1 (3rd trimester - 30-25 gestational weeks), visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).
Diastolic blood pressure
Time frame: Visit 1 (3rd trimester - 30-25 gestational weeks), visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).
Recovery of gestational weight gain
Time frame: Visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).
Glucose
Time frame: Visit 1 (3rd trimester - 30-25 gestational weeks), visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).
Haemoglobin A1c
Time frame: Visit 1 (3rd trimester - 30-25 gestational weeks), visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
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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.
Inês Falcão Pires, PhD principal investigator
Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet Intervention Group in people with Postpartum and Cardiometabolic Factors, run by Universidade do Porto at 1 site in Portugal.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 26 Jun 2025. 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 Portugal. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juliana Morais, Master (220426820 ext. +351, ju_morais17@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Mediterranean Diet Adherence (time frame: Visit 1 (3rd trimester - 30-25 gestational weeks), visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2025.