TY - JOUR
T1 - Healthy lifestyle before and during pregnancy to prevent childhood obesity
T2 - study protocol for a parallel group randomised trial - the PRE-STORK trial
AU - Kornerup, Nina
AU - Danielsen, Julie Hagstrøm
AU - Sahl, Ronni Eg
AU - Pico, Majken Lillholm
AU - Johansen, Mette Yun
AU - Knop, Filip K
AU - Bønnelykke, Klaus
AU - Bergholt, Thomas
AU - Kelstrup, Louise
AU - Foghsgaard, Signe
AU - Ghauri, Nida
AU - Grønlund, Emilie
AU - Lund, Lærke
AU - Vinter, Christina Anne
AU - Lyng Forman, Julie
AU - Barrès, Romain
AU - Kragelund Nielsen, Karoline
AU - Andersen, Andreas
AU - Torekov, Signe S
AU - Groth Grunnet, Louise
AU - Vilsbøll, Tina
N1 - © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.
PY - 2025
Y1 - 2025
N2 - INTRODUCTION: The global prevalence of people living with overweight has tripled since 1975 and more than 40% of Danish women enter pregnancy being overweight. With the increasing rates of obesity observed in children, adolescents and adults, there is an urgent need for preventive measures. Risk factors for childhood obesity include maternal overweight or obesity before conception and excessive weight gain during pregnancy. Interventions aimed at modifying maternal lifestyle during pregnancy have demonstrated minimal positive or no impact on the health of the children. The 'healthy lifestyle before and during pregnancy to prevent childhood obesity - the PRE-STORK trial' aims to provide insights into the effect of a lifestyle intervention initiated before conception and continued during pregnancy in women with overweight or obesity, on neonatal adiposity in their children.METHODS AND ANALYSIS: In this randomised, two-arm, parallel-group, controlled trial, we will include 360 women with overweight or obesity (aged 18-40; body mass index 25-44 kg/m2) and their partners. The women will be randomised to receive either standard of care or a lifestyle intervention focused on preconception body weight reduction, regular physical exercise, healthy diet and support from a mentor before and during pregnancy. The primary outcome is the difference in neonatal adiposity measured in their children at birth. Children conceived during the trial will constitute a birth cohort, monitoring the effects on their health until the age of 18 years.ETHICS AND DISSEMINATION: The trial has been approved by the Regional Committee on Health Research Ethics in the Capital Region of Denmark (identification number H-22011403) and will be conducted in agreement with the Declaration of Helsinki. All results, whether positive, negative and inconclusive, will be disseminated at national or international scientific meetings and in peer-reviewed scientific journals.TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT05578690 (October 2022).
AB - INTRODUCTION: The global prevalence of people living with overweight has tripled since 1975 and more than 40% of Danish women enter pregnancy being overweight. With the increasing rates of obesity observed in children, adolescents and adults, there is an urgent need for preventive measures. Risk factors for childhood obesity include maternal overweight or obesity before conception and excessive weight gain during pregnancy. Interventions aimed at modifying maternal lifestyle during pregnancy have demonstrated minimal positive or no impact on the health of the children. The 'healthy lifestyle before and during pregnancy to prevent childhood obesity - the PRE-STORK trial' aims to provide insights into the effect of a lifestyle intervention initiated before conception and continued during pregnancy in women with overweight or obesity, on neonatal adiposity in their children.METHODS AND ANALYSIS: In this randomised, two-arm, parallel-group, controlled trial, we will include 360 women with overweight or obesity (aged 18-40; body mass index 25-44 kg/m2) and their partners. The women will be randomised to receive either standard of care or a lifestyle intervention focused on preconception body weight reduction, regular physical exercise, healthy diet and support from a mentor before and during pregnancy. The primary outcome is the difference in neonatal adiposity measured in their children at birth. Children conceived during the trial will constitute a birth cohort, monitoring the effects on their health until the age of 18 years.ETHICS AND DISSEMINATION: The trial has been approved by the Regional Committee on Health Research Ethics in the Capital Region of Denmark (identification number H-22011403) and will be conducted in agreement with the Declaration of Helsinki. All results, whether positive, negative and inconclusive, will be disseminated at national or international scientific meetings and in peer-reviewed scientific journals.TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT05578690 (October 2022).
KW - Humans
KW - Female
KW - Pregnancy
KW - Pediatric Obesity/prevention & control
KW - Healthy Lifestyle
KW - Adult
KW - Adolescent
KW - Randomized Controlled Trials as Topic
KW - Denmark
KW - Exercise
KW - Young Adult
KW - Infant, Newborn
KW - Preconception Care/methods
KW - Pregnancy Complications/prevention & control
KW - Body Mass Index
KW - Overweight/prevention & control
U2 - 10.1136/bmjopen-2024-087895
DO - 10.1136/bmjopen-2024-087895
M3 - Journal article
C2 - 39863406
VL - 15
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 1
M1 - e087895
ER -