Healthy lifestyle before and during pregnancy to prevent childhood obesity: study protocol for a parallel group randomised trial — the PRE-STORK trial
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 fact...
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BMJ Publishing Group
2025-01-01
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| author | Tina Vilsbøll Signe S Torekov Julie Lyng Forman Romain Barrès Andreas Andersen Filip K Knop Signe Foghsgaard Klaus Bønnelykke Thomas Bergholt Karoline Kragelund Nielsen Christina Anne Vinter Majken Lillholm Pico Louise Groth Grunnet Nina Kornerup Julie Hagstrøm Danielsen Ronni Eg Sahl Mette Yun Johansen Louise Kelstrup Nida Ghauri Emilie Grønlund Lærke Lund |
| author_facet | Tina Vilsbøll Signe S Torekov Julie Lyng Forman Romain Barrès Andreas Andersen Filip K Knop Signe Foghsgaard Klaus Bønnelykke Thomas Bergholt Karoline Kragelund Nielsen Christina Anne Vinter Majken Lillholm Pico Louise Groth Grunnet Nina Kornerup Julie Hagstrøm Danielsen Ronni Eg Sahl Mette Yun Johansen Louise Kelstrup Nida Ghauri Emilie Grønlund Lærke Lund |
| author_sort | Tina Vilsbøll |
| collection | DOAJ |
| description | 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). |
| format | Article |
| id | doaj-art-139fbbdde5724caea0c65c3ef94398e6 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMJ Publishing Group |
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| spelling | doaj-art-139fbbdde5724caea0c65c3ef94398e62025-01-27T09:35:10ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2024-087895Healthy lifestyle before and during pregnancy to prevent childhood obesity: study protocol for a parallel group randomised trial — the PRE-STORK trialTina Vilsbøll0Signe S Torekov1Julie Lyng Forman2Romain Barrès3Andreas Andersen4Filip K Knop5Signe Foghsgaard6Klaus Bønnelykke7Thomas Bergholt8Karoline Kragelund Nielsen9Christina Anne Vinter10Majken Lillholm Pico11Louise Groth Grunnet12Nina Kornerup13Julie Hagstrøm Danielsen14Ronni Eg Sahl15Mette Yun Johansen16Louise Kelstrup17Nida Ghauri18Emilie Grønlund19Lærke Lund20Steno Diabetes Centre Copenhagen, University of Copenhagen, Herlev, DenmarkDepartment of Biomedical Sciences, University of Copenhagen, Copenhagen, DenmarkSection of Biostatistics, Department of Public Health, University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, DenmarkNovo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark1Bandim Health Project, Indepth Network, Bissau, Guinea-BissauDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, DenmarkDepartment of Obstetrics, Herlev Hospital, Herlev, Hovedstaden, DenmarkCopenhagen Prospective Studies on Asthma in Childhood (COPSAC), Gentofte, DenmarkDepartment of Obstetrics, Copenhagen University Hospital - Rigshospitalet, Copenhagen, DenmarkDepartment of Prevention, Health Promotion and Community Care, Steno Diabetes Center Copenhagen, Herlev, DenmarkDepartment of Clinical Research, University of Southern Denmark, Odense, Denmark4 Copenhagen University Hospital, Steno Diabetes Center Copenhagen, Herlev, Denmark4 Copenhagen University Hospital, Steno Diabetes Center Copenhagen, Herlev, DenmarkClinical and Translational Research, Steno Diabetes Center Copenhagen, Herlev, DenmarkClinical and Translational Research, Steno Diabetes Center Copenhagen, Herlev, DenmarkClinical and Translational Research, Steno Diabetes Center Copenhagen, Herlev, DenmarkClinical and Translational Research, Steno Diabetes Center Copenhagen, Herlev, DenmarkDepartment of Clinical Medicine, University of Copenhagen Faculty of Health and Medical Sciences, Kobenhavn, DenmarkClinical and Translational Research, Steno Diabetes Center Copenhagen, Herlev, DenmarkClinical and Translational Research, Steno Diabetes Center Copenhagen, Herlev, DenmarkClinical and Translational Research, Steno Diabetes Center Copenhagen, Herlev, DenmarkIntroduction 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).https://bmjopen.bmj.com/content/15/1/e087895.full |
| spellingShingle | Tina Vilsbøll Signe S Torekov Julie Lyng Forman Romain Barrès Andreas Andersen Filip K Knop Signe Foghsgaard Klaus Bønnelykke Thomas Bergholt Karoline Kragelund Nielsen Christina Anne Vinter Majken Lillholm Pico Louise Groth Grunnet Nina Kornerup Julie Hagstrøm Danielsen Ronni Eg Sahl Mette Yun Johansen Louise Kelstrup Nida Ghauri Emilie Grønlund Lærke Lund Healthy lifestyle before and during pregnancy to prevent childhood obesity: study protocol for a parallel group randomised trial — the PRE-STORK trial BMJ Open |
| title | Healthy lifestyle before and during pregnancy to prevent childhood obesity: study protocol for a parallel group randomised trial — the PRE-STORK trial |
| title_full | Healthy lifestyle before and during pregnancy to prevent childhood obesity: study protocol for a parallel group randomised trial — the PRE-STORK trial |
| title_fullStr | Healthy lifestyle before and during pregnancy to prevent childhood obesity: study protocol for a parallel group randomised trial — the PRE-STORK trial |
| title_full_unstemmed | Healthy lifestyle before and during pregnancy to prevent childhood obesity: study protocol for a parallel group randomised trial — the PRE-STORK trial |
| title_short | Healthy lifestyle before and during pregnancy to prevent childhood obesity: study protocol for a parallel group randomised trial — the PRE-STORK trial |
| title_sort | healthy lifestyle before and during pregnancy to prevent childhood obesity study protocol for a parallel group randomised trial the pre stork trial |
| url | https://bmjopen.bmj.com/content/15/1/e087895.full |
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