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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.
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.
Main hypothesis: specific interventions improving maternal lifestyle and well being have a positive impact on pregnancy outcomes as well as on fetal growth and development.
Secondary 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean diet | Active Comparator | Mediterranean diet supplemented with extra-virgin olive oil and mixed nuts. |
|
| Mindfulness | Active Comparator | Mindfulness-Based Stress Reduction program (MBSR) |
|
| No intervention | No Intervention | No intervention strategy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean diet | Behavioral | Mediterranean diet supplemented with extra-virgin olive oil and nuts |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fetal Growth Restriction (FGR) | Birth weight <10th percentile | Delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Perinatal Outcome (APO) Adverse Perinatal Outcome (APO) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal Programming | Neurodevelopment assessment with Bayley III test | Up to 24 months of age |
| Epigenetics | Different epigenetic changes in fetal cord blood in pregnancies affected by FGR who attend the interventional program as compared to pregnancies with no intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic Barcelona | Barcelona | 08036 | Spain | |||
| Hospital Sant Joan de Deu |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41780730 | Derived | Trejo-Dominguez A, Benitez L, Crovetto F, Casas R, Youssef L, Larroya M, Ruiz-Leon AM, Nakaki A, Genero M, Casas I, Novoa RH, Encabo N, Rahman M, Wang X, O'Sullivan JF, Hegarty NR, Vieta E, Gratacos E, Estruch R, Crispi F, Castro-Barquero S. Ultraprocessed foods consumption and risk of preeclampsia: a secondary analysis of the improving mothers for a better prenatal care trial Barcelona (IMPACT BCN) randomized clinical trial. Am J Clin Nutr. 2026 May;123(5):101255. doi: 10.1016/j.ajcnut.2026.101255. Epub 2026 Mar 2. | |
| 40759394 |
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Participants will be recruited in our unit and data will be available only for researchers involved in the study.
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| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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Randomized controlled trial with 3 arms of intervention
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Care provider will not know the arm of randomization
| Mindfulness | Behavioral | Mindfulness-Based Stress Reduction program (MBSR) |
|
| Pregnancy |
| Delivery |
| Barcelona |
| Spain |
| Derived |
| 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. |
| 38830408 | Derived | 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. |
| 37839546 | Derived | 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. |
| 37606923 | Derived | 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. |
| 34874420 | Derived | 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. |
| 34030703 | Derived | 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. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |