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. 2025 Jan 25;15(1):e087895.
doi: 10.1136/bmjopen-2024-087895.

Healthy lifestyle before and during pregnancy to prevent childhood obesity: study protocol for a parallel group randomised trial - the PRE-STORK trial

Nina Kornerup  1 , Julie Hagstrøm Danielsen  1 , Ronni Eg Sahl  1 , Majken Lillholm Pico  1   2 , Mette Yun Johansen  1   3 , Filip K Knop  3   4   5 , Klaus Bønnelykke  5   6 , Thomas Bergholt  5   7 , Louise Kelstrup  5   7 , Signe Foghsgaard  1   7 , Nida Ghauri  1 , Emilie Grønlund  1 , Lærke Lund  1 , Christina Anne Vinter  8   9 , Julie Lyng Forman  10 , Romain Barrès  11   12 , Karoline Kragelund Nielsen  2 , Andreas Andersen  1 , Signe S Torekov #  13 , Louise Groth Grunnet #  14 , Tina Vilsbøll #  14   5
Affiliations

Healthy lifestyle before and during pregnancy to prevent childhood obesity: study protocol for a parallel group randomised trial - the PRE-STORK trial

Nina Kornerup et al. BMJ Open. .

Abstract

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).

Keywords: General diabetes; Obesity; Overweight; Paediatric endocrinology; Pregnancy; Randomised Controlled Trial.

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Conflict of interest statement

Competing interests: NK, JHD, RES, MLP, SF, NG, EG, LL, KKN, AA, LGG and TV are employed at Steno Diabetes Center Copenhagen, a public hospital and research institution under the Capital Region of Denmark, which is partly funded by a grant from Novo Nordisk Foundation. RES owns shares in Novo Nordisk A/S. MYJ is currently employed in Novo Nordisk A/S. FKK has served on scientific advisory panels, been part of speaker's bureaus for, served as a consultant to and/or received research support from 89bio, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Gubra, Novo Nordisk, Sanofi, Structure Therapeutics, Zealand Pharma, Zucara; is a co-founder and minority shareholder in Antag Therapeutics and owns shares in Eli Lilly, Novo Nordisk and Zealand Pharma; is currently employed by Novo Nordisk. TB has received lecture fees from Novo Nordisk. LK owns shares in Novo Nordisk A/S. SF has been part of speaker's bureaus for Novo Nordisk. RB has received research grants from the Novo Nordisk Foundation. AA has received lecture fees from Eli Lilly. SST has received grants, honoraria for lectures and membership on an advisory panel for Novo Nordisk, Research grant from Embla, Horaria for lectures from Merck and Ferring. LGG owns shares in Novo Nordisk A/S. TV has served on scientific advisory panels, been part of speaker's bureaus for, served as a consultant to and/or received research support from Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, GSK, Novo Nordisk, Sanofi and Sun Pharmaceuticals.

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