Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-26 @ 5:13 PM
Study NCT ID:
NCT03166332
Status:
COMPLETED
Last Update Posted:
2022-04-19
First Post:
2017-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Mothers for a Better PrenAtal Care Trial Barcelona
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005317', 'term': 'Fetal Growth Retardation'}], 'ancestors': [{'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D038441', 'term': 'Diet, Mediterranean'}, {'id': 'D064866', 'term': 'Mindfulness'}], 'ancestors': [{'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'Care provider will not know the arm of randomization'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial with 3 arms of intervention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1221}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-16', 'studyFirstSubmitDate': '2017-04-19', 'studyFirstSubmitQcDate': '2017-05-22', 'lastUpdatePostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fetal Programming', 'timeFrame': 'Up to 24 months of age', 'description': 'Neurodevelopment assessment with Bayley III test'}, {'measure': 'Epigenetics', 'timeFrame': 'Delivery', 'description': 'Different epigenetic changes in fetal cord blood in pregnancies affected by FGR who attend the interventional program as compared to pregnancies with no intervention'}], 'primaryOutcomes': [{'measure': 'Fetal Growth Restriction (FGR)', 'timeFrame': 'Delivery', 'description': 'Birth weight \\<10th percentile'}], 'secondaryOutcomes': [{'measure': 'Adverse Perinatal Outcome (APO) Adverse Perinatal Outcome (APO)', 'timeFrame': 'Pregnancy', 'description': 'Development of one of the following conditions: preeclampsia, preterm delivery, severe FGR (birth weight \\<3rd percentile), perinatal mortality, metabolic acidosis, mejor neonatal morbidity (presence of intraventricular hemorrhage grade III/IV, necrotizing enterocolitis, periventricular leucomalacia, sepsis, broncopulmonary dysplasia, hypoxic ischemic encephalopathy)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mindfulness', 'Mediterranean diet', 'Neurodevelopment', 'Epigenetics', 'Fetal growth restriction'], 'conditions': ['Intrauterine Growth Restriction', 'Fetal Growth Retardation']}, 'referencesModule': {'references': [{'pmid': '40759394', 'type': 'DERIVED', 'citation': 'Selma-Royo M, Crispi F, Castro-Barquero S, Casas I, Larroya M, Genero M, Paules C, Benitez L, Youssef L, Pascal R, Encabo N, Nakaki A, Martin-Asuero A, Oller-Guzman MT, Arranz A, Vieta E, Casas R, Estruch R, Gratacos E, Collado MC, Crovetto F. Effects of Mediterranean diet or Mindfulness-Based Stress Reduction during pregnancy on maternal gut and vaginal microbiota: a subanalysis of the Improving Mothers for a better PrenAtal Care Trial BarCeloNa (IMPACT BCN) trial. Am J Clin Nutr. 2025 Oct;122(4):1121-1133. doi: 10.1016/j.ajcnut.2025.07.030. Epub 2025 Aug 5.'}, {'pmid': '38830408', 'type': 'DERIVED', 'citation': 'Castro-Barquero S, Crovetto F, Estruch R, Ruiz-Leon AM, Larroya M, Sacanella E, Casanovas-Garriga F, Casas I, Nakaki A, Youssef L, Trejo-Dominguez A, Benitez L, Genero M, Vieta E, Gratacos E, Crispi F, Casas R. Validation of a pregnancy-adapted Mediterranean Diet Adherence Screener (preg-MEDAS): a validation study nested in the Improving Mothers for a better PrenAtal Care Trial BarCeloNa (IMPACT BCN) trial. Am J Clin Nutr. 2024 Aug;120(2):449-458. doi: 10.1016/j.ajcnut.2024.05.025. Epub 2024 Jun 1.'}, {'pmid': '37839546', 'type': 'DERIVED', 'citation': 'Nakaki A, Crovetto F, Urru A, Piella G, Borras R, Comte V, Vellve K, Paules C, Segales L, Dacal M, Gomez Y, Youssef L, Casas R, Castro-Barquero S, Martin-Asuero A, Oller Guzman T, Morilla I, Martinez-Aran A, Camacho A, Pascual Tutusaus M, Arranz A, Rebollo-Polo M, Gomez-Chiari M, Bargallo N, Pozo OJ, Gomez-Gomez A, Izquierdo Renau M, Eixarch E, Vieta E, Estruch R, Crispi F, Gonzalez-Ballester MA, Gratacos E. Effects of Mediterranean diet or mindfulness-based stress reduction on fetal and neonatal brain development: a secondary analysis of a randomized clinical trial. Am J Obstet Gynecol MFM. 2023 Dec;5(12):101188. doi: 10.1016/j.ajogmf.2023.101188. Epub 2023 Oct 14.'}, {'pmid': '37606923', 'type': 'DERIVED', 'citation': 'Crovetto F, Nakaki A, Arranz A, Borras R, Vellve K, Paules C, Boutet ML, Castro-Barquero S, Freitas T, Casas R, Martin-Asuero A, Oller Guzman T, Morilla I, Martinez-Aran A, Camacho A, Pasqual M, Izquierdo Renau M, Pozo OJ, Gomez-Gomez A, Estruch R, Vieta E, Crispi F, Gratacos E. Effect of a Mediterranean Diet or Mindfulness-Based Stress Reduction During Pregnancy on Child Neurodevelopment: A Prespecified Analysis of the IMPACT BCN Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2330255. doi: 10.1001/jamanetworkopen.2023.30255.'}, {'pmid': '34874420', 'type': 'DERIVED', 'citation': 'Crovetto F, Crispi F, Casas R, Martin-Asuero A, Borras R, Vieta E, Estruch R, Gratacos E; IMPACT BCN Trial Investigators. Effects of Mediterranean Diet or Mindfulness-Based Stress Reduction on Prevention of Small-for-Gestational Age Birth Weights in Newborns Born to At-Risk Pregnant Individuals: The IMPACT BCN Randomized Clinical Trial. JAMA. 2021 Dec 7;326(21):2150-2160. doi: 10.1001/jama.2021.20178.'}, {'pmid': '34030703', 'type': 'DERIVED', 'citation': 'Crovetto F, Crispi F, Borras R, Paules C, Casas R, Martin-Asuero A, Arranz A, Vieta E, Estruch R, Gratacos E. Mediterranean diet, Mindfulness-Based Stress Reduction and usual care during pregnancy for reducing fetal growth restriction and adverse perinatal outcomes: IMPACT BCN (Improving Mothers for a better PrenAtal Care Trial BarCeloNa): a study protocol for a randomized controlled trial. Trials. 2021 May 24;22(1):362. doi: 10.1186/s13063-021-05309-2.'}]}, 'descriptionModule': {'briefSummary': 'High risk women for growth restricted fetuses will randomized in the second trimester into different strategies applied to the mothers: a stress reduction program based on mindfulness techniques or a nutrition interventional program based on Mediterranean diet.', 'detailedDescription': "Randomized controlled trial among women at higher risk to have a growth restricted fetus (30%) according to Royal College of Obstetrics and Gynecology (RCOG) Guidelines. These high-risk women will be randomized in order to evaluate an improvement in several outcomes thanks to different strategies applied to the mothers: a stress reduction program based on mindfulness techniques or a nutrition interventional program based on Mediterranean diet.\n\nMain hypothesis: specific interventions improving maternal lifestyle and well being have a positive impact on pregnancy outcomes as well as on fetal growth and development.\n\nSecondary hypothesis is that interventions to improve maternal lifestyle well being have a positive impact on offspring's outcome later in life, in terms of neurodevelopment and cardiovascular profile, mediated by epigenetic changes in offspring."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Maternal age at recruitment ≥18 years\n* Speak Spanish fluently\n* Viable singleton non-malformed fetus\n* High-risk pregnancy to develop FGR.\n* 19-23 weeks of gestation\n\nExclusion Criteria:\n\n* Fetal anomalies including chromosomal abnormalities or structural malformations detected by ultrasound.\n* Mental retardation or other mental or psychiatric disorders that impose doubts regarding the true patient´s willingness to participate in the study.\n* No possibility to come to additional visits.'}, 'identificationModule': {'nctId': 'NCT03166332', 'acronym': 'IMPACTBCN', 'briefTitle': 'Improving Mothers for a Better PrenAtal Care Trial Barcelona', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Improving Mothers for a Better PrenAtal Care Trial Barcelona', 'orgStudyIdInfo': {'id': 'IMPACT BCN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mediterranean diet', 'description': 'Mediterranean diet supplemented with extra-virgin olive oil and mixed nuts.', 'interventionNames': ['Behavioral: Mediterranean diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mindfulness', 'description': 'Mindfulness-Based Stress Reduction program (MBSR)', 'interventionNames': ['Behavioral: Mindfulness']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'No intervention strategy'}], 'interventions': [{'name': 'Mediterranean diet', 'type': 'BEHAVIORAL', 'description': 'Mediterranean diet supplemented with extra-virgin olive oil and nuts', 'armGroupLabels': ['Mediterranean diet']}, {'name': 'Mindfulness', 'type': 'BEHAVIORAL', 'description': 'Mindfulness-Based Stress Reduction program (MBSR)', 'armGroupLabels': ['Mindfulness']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Sant Joan de Deu', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Participants will be recruited in our unit and data will be available only for researchers involved in the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of ICGON and BCNatal', 'investigatorFullName': 'Eduard Gratacós Solsona', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}