Ferrari Nina, Schmitz Laura, Schmidt Nikola, Mahabir Esther, Van de Vondel Patricia, Merz Waltraut M, Lehmacher Walter, Stock Stephanie, Brockmeier Konrad, Ensenauer Regina, Fehm Tanja, Joisten Christine
Cologne Centre for Prevention in Childhood and Youth/ Heart Centre Cologne, University Hospital of Cologne, Kerpener Str. 62, 50937 Cologne, Germany.
Department for physical activity in public health, Institute of Movement and Neurosciences, German Sport University Cologne, Am Sportpark Müngersdorf 6, 50933 Cologne, Germany.
BMC Sports Sci Med Rehabil. 2020 Sep 10;12:55. doi: 10.1186/s13102-020-00198-5. eCollection 2020.
The prevalence of obesity in childhood is increasing worldwide and may be affected by genetic factors and the lifestyle (exercise, nutrition behavior) of expectant parents. Lifestyle factors affect adipokines, namely leptin, resistin, and adiponectin as well as cytokines such as tumor necrosis factor alpha (TNF-α) and interleukin-6 (IL-6), which are involved in the regulation of maternal metabolic homeostasis, glucose metabolism, and the development of insulin resistance, metabolic syndrome, gestational diabetes mellitus, and hypertension. However, studies focusing on the effect of exercise or a combination of parental exercise and nutrition on the above-mentioned markers in newborns (venous cord blood) and especially on the long-term development of infants' weight gain are lacking. The study will investigate the effects of a multimodal intervention (regular exercise, diet) on parental and childhood adipocytokines (leptin, resistin, adiponectin, TNF-α, IL-6, BDNF). The effect of a lifestyle-related change in "fetal environmental conditions" on the long-term weight development of the child up to the age of two will also be assessed.
METHODS/DESIGN: A randomized multi-center controlled trial will be conducted in Germany, comparing supervised aerobic and resistance training 2x/week (13th to 36th weeks of gestation) and nutritional counseling (6th to 36th weeks of gestation) during pregnancy with usual care. Thirty women (pre-pregnancy Body Mass Index ≥25 kg/m, 6th-10th week of gestation) will be included in each group. Maternal anthropometric and physical measurements as well as blood sampling will occur at the 6th-10th, 13th-14th, 21st-24th, and 36th week of gestation, at delivery as well as 8 weeks and 24 months postpartum. Neonatal measurements and umbilical blood sampling will be performed at birth. Maternal and infants' weight development will be assessed every 6 months till 24 months postpartum. A difference in childhood BMI of 1 kg/m at the age of two years between both groups will be assumed. A power size of 80% using a significance level of 0.05 and an effect size of 1.0 is presumed.
A better understanding of how lifestyle-related changes in the fetal environment might influence infants' outcome after two years of life could have a profound impact on the prevention and development of infants' obesity.
The trial is registered at the German Clinical Trial Register (DRKS00007702); Registered on 10th of August 2016; retrospectively registered https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00007702.
儿童肥胖症在全球范围内的患病率正在上升，可能受到遗传因素以及准父母生活方式（运动、营养行为）的影响。生活方式因素会影响脂肪因子，即瘦素、抵抗素和脂联素，以及细胞因子，如肿瘤坏死因子α（TNF-α）和白细胞介素-6（IL-6），这些因子参与母体代谢稳态、葡萄糖代谢以及胰岛素抵抗、代谢综合征、妊娠期糖尿病和高血压的发展调节。然而，缺乏针对运动或父母运动与营养相结合对新生儿（脐静脉血）上述标志物的影响，尤其是对婴儿体重增加长期发展影响的研究。本研究将调查多模式干预（规律运动、饮食）对准父母及儿童脂肪细胞因子（瘦素、抵抗素、脂联素、TNF-α、IL-6、脑源性神经营养因子）的影响。还将评估“胎儿环境条件”中与生活方式相关的变化对儿童至两岁时体重长期发展的影响。
方法/设计：将在德国进行一项随机多中心对照试验，比较孕期每周两次（妊娠第13至36周）的有监督有氧和抗阻训练以及营养咨询（妊娠第6至36周）与常规护理。每组将纳入30名女性（孕前体重指数≥25kg/m²，妊娠第6至10周）。在妊娠第6至10周、13至14周、21至24周和36周、分娩时以及产后8周和24个月进行母体人体测量和身体检查以及血液采样。出生时进行新生儿测量和脐血采样。产后每6个月评估一次母婴体重发展情况。假设两组在儿童两岁时的BMI差异为1kg/m²。假定检验效能为80%，显著性水平为0.05，效应量为1.0。
更好地了解胎儿环境中与生活方式相关的变化如何可能影响婴儿两岁后的结局，可能对婴儿肥胖症的预防和发展产生深远影响。
该试验已在德国临床试验注册中心（DRKS00007702）注册；于2016年8月10日注册；追溯注册网址为https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00007702 。
