Last reviewed · How we verify
NCT03166332: IMPACTBCN
Improving Mothers for a Better PrenAtal Care Trial Barcelona
Completed
NA
Last updated 19 April 2022
What this trial tests
NA trial testing Mediterranean diet in Intrauterine Growth Restriction in 1,221 participants. Completed in 31 December 2021.
Timeline
1 February 2017
Primary endpoint
31 December 2020
31 December 2020
31 December 2021
Quick facts
| Lead sponsor | Hospital Clinic of Barcelona |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 1,221 |
| Start date | 1 February 2017 |
| Primary completion | 31 December 2020 |
| Estimated completion | 31 December 2021 |
| Sites | 2 locations across Spain |
Drugs / interventions tested
- Mediterranean diet
- Mindfulness
Conditions studied
- Intrauterine Growth Restriction — all drugs for Intrauterine Growth Restriction →
- Fetal Growth Retardation — all drugs for Fetal Growth Retardation →
Sponsor
Hospital Clinic of Barcelona
Who can join
18 and older, female only, with Intrauterine Growth Restriction or Fetal Growth Retardation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
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.
Crovetto F, Crispi F, Casas R, Martín-Asuero A, et al · · 2021 · cited 83× · PMID 34874420 · DOI 10.1001/jama.2021.20178 -
Reliability and Concurrent and Construct Validity of a Food Frequency Questionnaire for Pregnant Women at High Risk to Develop Fetal Growth Restriction.
Juton C, Castro-Barquero S, Casas R, Freitas T, et al · · 2021 · cited 32× · PMID 34066238 · DOI 10.3390/nu13051629 -
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.
Crovetto F, Nakaki A, Arranz A, Borras R, et al · · 2023 · cited 25× · PMID 37606923 · DOI 10.1001/jamanetworkopen.2023.30255 -
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 tri
Crovetto F, Crispi F, Borras R, Paules C, et al · · 2021 · cited 22× · PMID 34030703 · DOI 10.1186/s13063-021-05309-2 -
Effects of a Mediterranean Diet Intervention on Maternal Stress, Well-Being, and Sleep Quality throughout Gestation-The IMPACT-BCN Trial.
Casas I, Nakaki A, Pascal R, Castro-Barquero S, et al · · 2023 · cited 13× · PMID 37242244 · DOI 10.3390/nu15102362 -
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.
Castro-Barquero S, Crovetto F, Estruch R, Ruiz-León AM, et al · · 2024 · cited 6× · PMID 38830408 · DOI 10.1016/j.ajcnut.2024.05.025 -
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.
Selma-Royo M, Crispi F, Castro-Barquero S, Casas I, et al · · 2025 · cited 4× · PMID 40759394 · DOI 10.1016/j.ajcnut.2025.07.030 -
Prediction of low birth weight from fetal ultrasound and clinical characteristics: a comparative study between a low- and middle-income and a high-income country.
Sanchez-Martinez S, Marti-Castellote PM, Hoodbhoy Z, Bernardino G, et al · · 2024 · cited 2× · PMID 39638610 · DOI 10.1136/bmjgh-2024-016088
Verify or expand the search:
- PubMed search for NCT03166332
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Mediterranean diet
Trials testing the same drug.
- NCT07385716 — Evaluation of the Effect of Time-Restricted Feeding and Mediterranean Diet Model in Women With Polycystic Ovary Syndrome · NA · recruiting
- NCT07017127 — Remission of Type 2 Diabetes With Lifestyle Intervention · NA · recruiting
- NCT07055620 — Effects of Different Dietary Models on Eating Behavior and Obesity Management in Overweight and Obese Individuals · NA · completed
- NCT06774079 — Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients · Phase 4 · recruiting
- NCT06765369 — How the Mediterranean Diet Affects You: Predicting Responses Based on Your Microbiome · NA · not yet recruiting
Other recruiting trials for Intrauterine Growth Restriction
Currently open trials in the same condition.
- NCT06534307 — Long-term Follow-up of Children Born in the PETN Studies · recruiting
- NCT06115122 — PEPPI Study: Identification of Women at Risk for Placental Dysfunction · recruiting
- NCT06074601 — MIRACLE of LIFE Study · active not recruiting
- NCT04766866 — sFlt1/PlGF and Planned Delivery to Prevent Preeclampsia at Term. · NA · recruiting
- NCT03398629 — Diagnosis and Management of Intrauterine Growth Restriction and Congenital Anomalies · recruiting
Other Hospital Clinic of Barcelona trials
Trials by the same sponsor.
- NCT07509814 — Extended Versus Short Prehabilitation Programme for Patients With Advanced Ovarian Cancer Undergoing Major Surgery · NA · not yet recruiting
- NCT07469358 — iCBT for Adolescents Obsessive-compulsive Dissorder · NA · active not recruiting
- NCT07358611 — Non-invasive Mapping-Guided Atrial Fibrillation Ablation · NA · recruiting
- NCT07237867 — Frequency-Dependent Effects of Percutaneous Femoral Nerve Stimulation on Quadriceps Strength in Athletes With Patellar T · NA · recruiting
- NCT07163936 — Analysis of the Influence of Dialysis Fluid Composition on Vascular Calcification in Patients With Chronic Kidney Diseas · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03166332 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Clinic of Barcelona
- Last refreshed: 19 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03166332.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing