Thibodeau Alexandra, Jean-Denis Farrah, Harnois-Leblanc Soren, Perron Patrice, Mathieu Marie-Eve, Dallaire Frédéric, Morisset Anne-Sophie, Brochu Martin, Baillargeon Jean-Patrice
Department of Medicine, Université de Sherbrooke, Sherbrooke, Quebec, Canada.
Research Center, Centre intégré universitaire de santé et de services sociaux de l'Estrie Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.
BMJ Open. 2025 Apr 17;15(4):e091140. doi: 10.1136/bmjopen-2024-091140.
Maternal preconception obesity and adverse gestational metabolic health increase the risk of childhood obesity in offspring, but the preconception period may be an opportune time to intervene, given the motivation of the mother and the epigenetic changes that may be beneficial for the gametes during this period. However, there is a lack of studies evaluating children born to women who have had a preconception intervention. Our group has therefore designed an ancillary study to assess children born to women enrolled in the obesity-fertility randomised controlled trial (RCT), who were 6-12 years of age, with the objective of evaluating the effect of a lifestyle intervention delivered during preconception and pregnancy on adiposity and cardiometabolic parameters in the offspring. This manuscript details the study protocol.
This is an ancillary nested cohort study of the obesity-fertility RCT. Women with obesity and infertility were recruited at an academic fertility clinic and randomised to the control group, which followed usual care, or to the intervention group, which received a lifestyle intervention alone for the first 6 months and then in combination with fertility treatments for up to 18 months or until the end of pregnancy. Those who have given birth to a single child are invited to participate in this follow-up study with their child aged 6-12 years. This study started in November 2023 and is expected to end in May 2025. The primary outcome is age-adjusted and sex-adjusted body mass index z-scores in children. Secondary outcomes are anthropometry, body composition, lifestyle, physical fitness level and blood or saliva markers of cardiometabolic health in both mothers and children. Of the 130 women who participated in the obesity-fertility RCT, 52 mother-child dyads (24 in the control group; 28 in the intervention group) were potentially eligible for this follow-up study. Comparisons between groups will be performed using unpaired tests and adjusted for potential confounders using multivariable regression models. This study will provide important new data on the impact of a preconception lifestyle intervention, maintained throughout pregnancy, on the health trajectory of children and mothers 6-12 years after delivery.
The study has been approved by the institutional research ethics review boards of the . The results will be widely disseminated to the scientific community, relevant health professionals and general public.
ClinicalTrials.gov (NCT06402825).
孕前肥胖和孕期不良代谢健康状况会增加后代儿童肥胖的风险，但鉴于母亲的积极性以及在此期间可能对配子有益的表观遗传变化，孕前阶段可能是进行干预的合适时机。然而，目前缺乏对接受孕前干预的女性所生育子女的研究。因此，我们团队设计了一项辅助研究，以评估参与肥胖与生育随机对照试验（RCT）的女性所生育的6至12岁儿童，目的是评估孕前和孕期进行的生活方式干预对后代肥胖和心脏代谢参数的影响。本手稿详细介绍了研究方案。
这是肥胖与生育RCT的一项辅助嵌套队列研究。在一家学术性生育诊所招募肥胖且不孕的女性，并将她们随机分为对照组（接受常规护理）或干预组（前6个月仅接受生活方式干预，然后与生育治疗联合进行长达18个月或直至妊娠结束）。那些生育了单胎子女的女性被邀请与她们6至12岁的孩子一起参与这项随访研究。本研究于2023年11月开始，预计于2025年5月结束。主要结局是儿童经年龄和性别调整的体重指数z评分。次要结局包括母亲和儿童的人体测量学、身体成分、生活方式、体能水平以及心脏代谢健康的血液或唾液标志物。在参与肥胖与生育RCT的130名女性中，52对母婴二元组（对照组24对；干预组28对）可能符合这项随访研究的条件。将使用非配对检验进行组间比较，并使用多变量回归模型对潜在混杂因素进行调整。本研究将提供关于孕前生活方式干预在整个孕期持续进行对产后6至12年儿童和母亲健康轨迹影响的重要新数据。
该研究已获得……的机构研究伦理审查委员会的批准。研究结果将广泛传播给科学界、相关健康专业人员和普通公众。
ClinicalTrials.gov（NCT06402825）。
