Coppola Serena, Paparo Lorella, Bedogni Giorgio, Nocerino Rita, Costabile Davide, Cuomo Mariella, Chiariotti Lorenzo, Carucci Laura, Agangi Annalisa, Napolitano Marcello, Messina Francesco, Passariello Annalisa, Berni Canani Roberto
Department of Translational Medical Science, University of Naples Federico II, Via Sergio Pansini 5, 80131, Naples, Italy.
CEINGE Advanced Biotechnologies, University of Naples Federico II, Via Gaetano Salvatore 486, 80131, Naples, Italy.
Int J Obes (Lond). 2025 Jan;49(1):101-108. doi: 10.1038/s41366-024-01626-z. Epub 2024 Sep 18.
BACKGROUND/OBJECTIVES: The PREMEDI study was designed to assess the efficacy of nutritional counseling aimed at promoting Mediterranean Diet (MD) during pregnancy on the incidence of overweight or obesity at 24 months in the offspring.
PREMEDI was a parallel-arm randomized-controlled trial. 104 women in their first trimester of pregnancy were randomly assigned in a 1:1 ratio to standard obstetrical and gynecological care alone (CT) or with nutritional counseling promoting MD. Women enrolled in the MD arm were provided with 3 sessions of nutritional counseling (one session per trimester). The main outcome was the proportion of overweight or obesity among the offspring at the age of 24 months. Maternal MD-adherence and weight gain during pregnancy were also evaluated. Lastly, the evaluation of epigenetic modulation of metabolic pathways in the offspring was analyzed in cord blood.
Five women in the MD arm and 2 in the CT arm were lost to follow-up, so a total of 97 completed the study. At 24 months, children of MD mothers were less likely to have overweight or obesity than those of the CT mothers (6% vs. 30%, absolute risk difference = -24%, 95% CI -38% to -9%, p = 0.003, number needed to treat 4, 95% CI 2 to 12, per-protocol analysis). A significantly higher increase of MD-adherence during the trial was observed in the MD arm compared to the CT arm. A similar body weight gain at the end of pregnancy was observed in the two arms. The mean (SD) methylation rate of the leptin gene in cord blood was 30.4 (1.02) % and 16.9 (2.99) % in the MD and CT mothers, respectively (p < 0.0001).
MD during pregnancy could be an effective strategy for preventing pediatric overweight or obesity at 24 months. This effect involves, at least in part, an epigenetic modification of leptin expression.
背景/目的：PREMEDI研究旨在评估孕期旨在促进地中海饮食（MD）的营养咨询对后代24个月时超重或肥胖发生率的影响。
PREMEDI是一项平行组随机对照试验。104名孕早期妇女按1:1比例随机分配，分别接受单纯标准妇产科护理（CT组）或接受促进MD的营养咨询。MD组的妇女接受了3次营养咨询（每孕期1次）。主要结局是后代24个月时超重或肥胖的比例。还评估了孕妇对MD的依从性和孕期体重增加情况。最后，对脐血中后代代谢途径的表观遗传调控进行了分析。
MD组有5名妇女、CT组有2名妇女失访，因此共有97人完成了研究。在24个月时，MD组母亲的孩子超重或肥胖的可能性低于CT组母亲的孩子（6%对30%，绝对风险差异=-24%，95%CI -38%至-9%，p=0.003，治疗所需人数为4，95%CI 2至12，符合方案分析）。与CT组相比，MD组在试验期间MD依从性的增加显著更高。两组在妊娠末期的体重增加相似。MD组和CT组母亲脐血中瘦素基因的平均（标准差）甲基化率分别为30.4（1.02）%和16.9（2.99）%（p<0.0001）。
孕期采用MD可能是预防儿童24个月时超重或肥胖的有效策略。这种效果至少部分涉及瘦素表达的表观遗传修饰。
