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.

Luef, B. M., Jensen, N. H., Knorr, S., Kristensen, K., Overgaard, M., Stentebjerg, L. L., Catalano, P. M., Möller, S., Maindal, H. T., Jensen, D. M., & Vinter, C. A. (2026). 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.. Trials, 27(1), 124.

Abstract

INTRODUCTION: Maternal 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.

METHODS: This study is a follow-up of a randomized controlled trial. In the original trial, 360 pregnant women with a BMI ≥ 30 kg/m2 from Odense and Aarhus University Hospitals were randomized to receive either lifestyle intervention, including diet counseling and physical activity from 12 weeks gestation until delivery, or standard care. A total of 301 mother-child pairs are eligible for follow-up. The mothers and their offspring will be invited to a 2-h clinical examination, which includes fasting venous blood samples, DXA scans, anthropometric measurements, and questionnaires addressing diet, physical activity, mental health, and health literacy. Examinations will include continuous glucose monitoring and activity tracking for 7-10 days. Our primary endpoint is the effect of lifestyle intervention during pregnancy on offspring body composition measured by DXA scanning.

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 REGISTRATION: The 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.

Last updated on 04/01/2026
PubMed