Study protocol for a 15-year follow-up of a randomized controlled trial on lifestyle intervention in pregnancy: assessing long-term effects on body composition, metabolic traits, and mental health in mothers and offspring.

introductionMaternal obesity is increasingly linked to adverse health effects across generations, with childhood obesity becoming one of the most critical public health challenges of the twenty-first century. Both a high maternal body mass index (BMI) and excessive gestational weight gain (GWG) are significant and independent predictors of future obesity in both children and adults. This study aims to evaluate the long-term impact of lifestyle interventions during pregnancy on the body composition of mothers and their 15-year-old offspring. Furthermore, we will investigate the influence of these interventions on dysmetabolic traits, and metabolic and inflammatory markers observed in mothers and their offspring 15 years post-pregnancy. The study also aims to examine the relationship between maternal mental health during pregnancy and postpartum, and long-term obesity risk. Finally, we will assess the mental health and health literacy of both mothers and offspring and evaluate its association with obesity risk.

methodsThis study is a follow-up of a randomized controlled trial. In the original trial, 360 pregnant women with a BMI ≥ 30 kg/m DISCUSSION: Our data address critical knowledge gaps in understanding childhood obesity. If pregnancy interventions reduce the risk of offspring's obesity, they could serve as a foundation for implementing changes in clinical practice.

trial registrationThe study was approved by the local ethics committee of the Region of Southern Denmark (S-20220076) and registered on ClinicalTrials.gov (NCT05774652) on March 21, 2023. The findings will be published in international scientific journals and shared with hospitals and policymakers.