Lifestyle intervention to improve outcomes in dichorionic twin pregnancies: study protocol for a multicentre randomised controlled trial with an integrated pilot study – the LIFETWIN trial
9 affiliations
- 1REALIFE Research Group, Research Unit Woman and Child, Department of Development and Regeneration, KU Leuven, Leuven, Belgium
- 2Academic Centre for Nursing and Midwifery (AccentVV), Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium
- 3Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium
- 4L-C&Y, KU Leuven Child & Youth Institute, KU Leuven, Leuven, Belgium
- 5University of Plymouth, Faculty of Health, Plymouth, UK
- 6Institute for Media Studies, Katholieke Universiteit Leuven Faculteit Sociale Wetenschappen, Leuven, Belgium
- 7Obstetrics and Gynecology Department, Centre Hospitalier Regional de la Citadelle, Liège, Belgium
- 8Department of Obstetrics and Gynecology, Hospital East-Limburg, Genk, Belgium
- 9Department of Obstetrics and Gynecology, Brugmann University Hospital, Brussels, Belgium
Abstract
Introduction Preterm birth and small-for-gestational-age (SGA) infants remain major contributors to neonatal morbidity, mortality and healthcare costs. Twin pregnancies account for a disproportionate share of these adverse outcomes, representing 18%–24% of all preterm births in Europe. Despite this high-risk profile, effective preventive strategies for twin pregnancies remain limited and mainly target cervical length. Emerging evidence suggests that maternal lifestyle factors, including diet, physical activity and stress management, may prolong gestational age and improve fetal growth.Methods and analysis The LIFEstyle intervention to improve TWIN pregnancy (LIFETWIN) - study is a multicentre, open-label, randomised controlled trial. A total of 274 women with dichorionic twin pregnancies will be recruited across 15 sites in Belgium. The full trial will be preceded by an integrated pilot study conducted at four sites to assess feasibility using the RE-AIM framework. Participants will be randomised to standard care or a lifestyle intervention in addition to standard care. The intervention consists of eight midwife-led sessions between gestational weeks 16 and 36, focusing on a Mediterranean-type diet, physical activity, mindfulness and prenatal multivitamin supplementation. Data are collected at baseline, in late pregnancy, at delivery and at 6 weeks postpartum, using clinical records, physical examinations and validated questionnaires. The primary outcome is gestational age at delivery. Secondary outcomes include neonatal birth weight, SGA status, neonatal morbidity and mortality, neonatal intensive care unit admission and length of stay, maternal gestational weight gain, postpartum weight and quality of life. The primary outcome, gestational age at delivery, will be analysed using a linear mixed-effects model, accounting for study-site effects and potential clustering by intervention midwife within the intervention arm. Secondary outcomes will be analysed using models appropriate to the outcome type, including linear mixed models, generalised mixed models and frailty models.Ethics and dissemination The trial has been approved by the central ethics committee of Leuven (identification number S68251) and by the local ethics committees of each participating site. The trial will be conducted in accordance with the Declaration of Helsinki. All results, whether positive, negative or inconclusive, will be disseminated at national or international scientific meetings and published in peer-reviewed scientific journals.Trial registration number NCT07270640.
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BibTeX
@article{lodewyckx2026lifestyle,
title = {{Lifestyle intervention to improve outcomes in dichorionic twin pregnancies: study protocol for a multicentre randomised controlled trial with an integrated pilot study – the LIFETWIN trial}},
author = {Katleen Lodewyckx and Yael Winter Shafran and Birgit Coucke and Martien Put and Liesbeth Lewi and Annick Bogaerts and Tim Smits and Laure Noel and Tinne Mesens and Jacques Jani and Roland Devlieger},
journal = {BMJ Open},
year = {2026},
month = oct,
doi = {10.1136/bmjopen-2026-122541},
url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-122541},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Lifestyle intervention to improve outcomes in dichorionic twin pregnancies: study protocol for a multicentre randomised controlled trial with an integrated pilot study – the LIFETWIN trial
AU - Katleen Lodewyckx
AU - Yael Winter Shafran
AU - Birgit Coucke
AU - Martien Put
AU - Liesbeth Lewi
AU - Annick Bogaerts
AU - Tim Smits
AU - Laure Noel
AU - Tinne Mesens
AU - Jacques Jani
AU - Roland Devlieger
PY - 2026
DA - 2026/10/23
JO - BMJ Open
DO - 10.1136/bmjopen-2026-122541
UR - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-122541
AB - Introduction Preterm birth and small-for-gestational-age (SGA) infants remain major contributors to neonatal morbidity, mortality and healthcare costs. Twin pregnancies account for a disproportionate share of these adverse outcomes, representing 18%–24% of all preterm births in Europe. Despite this high-risk profile, effective preventive strategies for twin pregnancies remain limited and mainly target cervical length. Emerging evidence suggests that maternal lifestyle factors, including diet, physical activity and stress management, may prolong gestational age and improve fetal growth.Methods and analysis The LIFEstyle intervention to improve TWIN pregnancy (LIFETWIN) - study is a multicentre, open-label, randomised controlled trial. A total of 274 women with dichorionic twin pregnancies will be recruited across 15 sites in Belgium. The full trial will be preceded by an integrated pilot study conducted at four sites to assess feasibility using the RE-AIM framework. Participants will be randomised to standard care or a lifestyle intervention in addition to standard care. The intervention consists of eight midwife-led sessions between gestational weeks 16 and 36, focusing on a Mediterranean-type diet, physical activity, mindfulness and prenatal multivitamin supplementation. Data are collected at baseline, in late pregnancy, at delivery and at 6 weeks postpartum, using clinical records, physical examinations and validated questionnaires. The primary outcome is gestational age at delivery. Secondary outcomes include neonatal birth weight, SGA status, neonatal morbidity and mortality, neonatal intensive care unit admission and length of stay, maternal gestational weight gain, postpartum weight and quality of life. The primary outcome, gestational age at delivery, will be analysed using a linear mixed-effects model, accounting for study-site effects and potential clustering by intervention midwife within the intervention arm. Secondary outcomes will be analysed using models appropriate to the outcome type, including linear mixed models, generalised mixed models and frailty models.Ethics and dissemination The trial has been approved by the central ethics committee of Leuven (identification number S68251) and by the local ethics committees of each participating site. The trial will be conducted in accordance with the Declaration of Helsinki. All results, whether positive, negative or inconclusive, will be disseminated at national or international scientific meetings and published in peer-reviewed scientific journals.Trial registration number NCT07270640.
SN - 2044-6055
SN - 2044-6055
ER -