[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595917":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":46,"studyPopulation":46,"armGroups":51,"interventions":64,"overallOfficials":73,"centralContacts":77,"locations":87,"responsibleParty":105,"collaborators":46,"id":107,"slug":46,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":108,"sex":114,"minAge":115,"maxAge":46,"enrollmentInfo":116,"targetDuration":46,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":127,"overallStatus":90,"whyStopped":46,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Universidade do Porto","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"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.\n\nThe MEDAS score ranges from 0 to 14, with higher scores indicating greater adherence to the Mediterranean Diet. Scores are commonly classified as follows:\n\n* Low adherence: \\\u003C 7\n* Moderate adherence: 7-9\n* High adherence: ≥ 10","Visit 1 (3rd trimester - 30-25 gestational weeks), visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum)",[14,18,21,24,26,30,32],{"measure":15,"description":16,"timeFrame":17},"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.\n\nCardiac reverse remodeling will be assessed as the change (Δ) in left ventricular (LV) mass between the third trimester of pregnancy and 6 months postpartum.\n\nConventional 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.\n\nLeft ventricular mass (g) will be estimated using the following formula:\n\nLV 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","Visit 1 (3rd trimester - 30-25 gestational weeks), visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).",{"measure":19,"description":20,"timeFrame":17},"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.",{"measure":22,"description":23,"timeFrame":17},"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.",{"measure":25,"description":23,"timeFrame":17},"Diastolic blood pressure",{"measure":27,"description":28,"timeFrame":29},"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.","Visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).",{"measure":31,"description":20,"timeFrame":17},"Glucose",{"measure":33,"description":20,"timeFrame":17},"Haemoglobin A1c",[35,38],{"measure":36,"description":37,"timeFrame":29},"Age of Infant at Introduction of Complementary Feeding","To assess the effect of dietary education counseling focused on Mediterranean Diet promotion (intervention group) vs nutritional standard care of the Portuguese National Health System (control group) on the timing of complementary feeding (solid food) introduction in infants.\n\nAt every time points, mothers will be asked using structured parental questionnaires to report the infant's age (in weeks) at the introduction of any solid or semi-solid foods, excluding breast milk or infant formula.\n\nThe primary metric will be the infant's age in weeks at first introduction of complementary feeding.",{"measure":39,"description":40,"timeFrame":29},"Duration of Exclusive Breastfeeding","To assess the effect of dietary education counseling focused on Mediterranean Diet promotion (intervention group) vs nutritional standard care of the Portuguese National Health System (control group) on the duration of exclusive breastfeeding.\n\nExclusive breastfeeding is defined according to WHO criteria as providing only breast milk with no additional food or drink, not even water, except for oral rehydration solutions or drops\u002Fsyrups of vitamins, minerals, or medicines.\n\nData will be collected via structured parental. Mothers will report whether they are exclusively breastfeeding and the age (in weeks) at which exclusive breastfeeding stopped, if applicable.\n\nThe outcome will be reported as the duration of exclusive breastfeeding in weeks.",{"allocation":42,"interventionModel":43,"interventionModelDescription":44,"primaryPurpose":45,"observationalModel":46,"timePerspective":46,"maskingInfo":47},"RANDOMIZED","PARALLEL","Prospective, randomized, two-treatment, one-period, parallel trial","PREVENTION",null,{"masking":48,"maskingDescription":46,"whoMasked":49},"SINGLE",[50],"PARTICIPANT",[52,58],{"label":53,"type":54,"description":55,"interventionNames":56},"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.",[57],"Other: Control Group (Standard Hospital Dietary Care)",{"label":59,"type":60,"description":61,"interventionNames":62},"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.",[63],"Other: Mediterranean Diet Intervention Group",[65,70],{"type":6,"name":59,"description":66,"armGroupLabels":67,"otherNames":68},"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.",[59],[69],"Diet group",{"type":6,"name":53,"description":71,"armGroupLabels":72,"otherNames":46},"The control group will receive standard care from the nutritionist in the hospital.",[53],[74],{"name":75,"affiliation":5,"role":76},"Inês Falcão Pires, PhD","PRINCIPAL_INVESTIGATOR",[78,84],{"name":79,"role":80,"phone":81,"phoneExt":82,"email":83},"Juliana Morais, Master","CONTACT","220426820","+351","ju_morais17@hotmail.com",{"name":85,"role":80,"phone":81,"phoneExt":82,"email":86},"Ana Filipa Ferreira, PhD","anaferreira.ferreira4@gmail.com",[88],{"facility":89,"status":90,"city":91,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"Unidade Local de Saúde de São João","RECRUITING","Porto","Viana do Castelo District","4200-319","Portugal","PT",{"type":97,"coordinates":98},"Point",[99,100],-8.45221,42.0213,{"lat":100,"lon":99},[103],{"name":79,"role":80,"phone":104,"phoneExt":82,"email":83},"225512100 + 962711106",{"type":106,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100595917",false,"NCT07038681","Mediterranean Diet Intervention for Maternal Postpartum","Mediterranean Diet Intervention for Maternal Postpartum Cardiometabolic and Microbiome Health (MedMom Study): a Randomized Trial","MedMom","Inclusion Criteria:\n\n* Adult female (\\>18 years old)\n* Obesity\n* Chronic arterial hypertension\n* Type 2 diabetes\n* Gestational hypertension\n* Gestational diabetes\n\nExclusion Criteria:\n\n* Preexisting cardiomyopathy;\n* Renal disease;\n* Chronic obstructive airway disease;\n* Active systemic infection;\n* Genetic syndromes;\n* Type 1 Diabetes mellitus","FEMALE","18 Years",{"count":117,"type":118},52,"ESTIMATED","INTERVENTIONAL",[121],"NA","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.\n\nThis 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\u002For diabetes.\n\nSecondarily, 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.",[124,125,126],"Postpartum","Cardiometabolic Factors","Cardiac Reverse Remodeling",[128,124,129,126],"Mediterranean Diet","Pregnancy","2025-06-17",{"date":132,"type":133},"2025-06-26","ACTUAL",{"date":135,"type":133},"2025-05-31",{"date":137,"type":118},"2025-12-31",{"name":5,"class":6},1]