Kornerup Nina, Danielsen Julie Hagstrøm, Sahl Ronni Eg, Pico Majken Lillholm, Johansen Mette Yun, Knop Filip K, Bønnelykke Klaus, Bergholt Thomas, Kelstrup Louise, Foghsgaard Signe, Ghauri Nida, Grønlund Emilie, Lund Lærke, Vinter Christina Anne, Lyng Forman Julie, Barrès Romain, Kragelund Nielsen Karoline, Andersen Andreas, Torekov Signe S, Groth Grunnet Louise, Vilsbøll Tina
Clinical and Translational Research, Steno Diabetes Center Copenhagen, Herlev, Denmark.
Department of Prevention, Health Promotion & Community Care, Steno Diabetes Center Copenhagen, Herlev, Denmark.
BMJ Open. 2025 Jan 25;15(1):e087895. doi: 10.1136/bmjopen-2024-087895.
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.
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/m) 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 and 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.
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.
ClinicalTrials.gov: NCT05578690 (October 2022).
自1975年以来，全球超重人群的患病率增长了两倍，超过40%的丹麦女性在怀孕时超重。随着儿童、青少年和成年人肥胖率的不断上升，迫切需要采取预防措施。儿童肥胖的风险因素包括孕前母亲超重或肥胖以及孕期体重过度增加。旨在改变孕期母亲生活方式的干预措施对儿童健康的积极影响微乎其微或没有影响。“孕前及孕期健康生活方式预防儿童肥胖——PRE-STORK试验”旨在深入了解超重或肥胖女性在孕前开始并在孕期持续进行的生活方式干预对其子女新生儿肥胖的影响。
在这项随机、双臂、平行组对照试验中，我们将纳入360名超重或肥胖女性（年龄18 - 40岁；体重指数25 - 44kg/m²）及其伴侣。这些女性将被随机分为接受标准护理或接受以孕前体重减轻、定期体育锻炼、健康饮食以及来自导师的支持和孕期指导为重点的生活方式干预组。主要结局是其子女出生时测量的新生儿肥胖差异。试验期间受孕的儿童将构成一个出生队列，监测对他们健康的影响直至18岁。
该试验已获得丹麦首都地区卫生研究伦理区域委员会的批准（识别号H - 22011403），并将按照《赫尔辛基宣言》进行。所有结果，无论阳性、阴性还是无结论性，都将在国家或国际科学会议以及同行评审的科学期刊上发表。
ClinicalTrials.gov：NCT05578690（2022年10月）
