Lipid-focused dietary education intervention in pregnant women: study protocol for an open-label, parallel, randomised, intervention study addressing adverse pregnancy outcomes in China

Yadi Zhang; Xiaoge Gao; Haiyan Zhu; Shengzhi Sun; Isobel R Contento; Pamela Ann Koch; Huanling Yu

doi:10.1136/bmjopen-2023-076911

Lipid-focused dietary education intervention in pregnant women: study protocol for an open-label, parallel, randomised, intervention study addressing adverse pregnancy outcomes in China

BMJ Open. 2024 Jan 4;14(1):e076911. doi: 10.1136/bmjopen-2023-076911.

Authors

Yadi Zhang^#¹, Xiaoge Gao^#², Haiyan Zhu³, Shengzhi Sun¹, Isobel R Contento², Pamela Ann Koch⁴, Huanling Yu⁵

Affiliations

¹ School of Public Health, Beijing Key Laboratory of Environmental Toxicology, Capital Medical University, Beijing, China.
² Program in Nutrition, Department of Health Studies & Applied Educational Psychology, Teachers College, Columbia University, New York city, New York, USA.
³ Department of Obstetrics and Gynecology, Capital Medical University, Beijing, China.
⁴ Program in Nutrition, Department of Health Studies & Applied Educational Psychology, Teachers College, Columbia University, New York city, New York, USA pak14@tc.columbia.edu yuhlzjl@ccmu.edu.cn.
⁵ School of Public Health, Beijing Key Laboratory of Environmental Toxicology, Capital Medical University, Beijing, China pak14@tc.columbia.edu yuhlzjl@ccmu.edu.cn.

^# Contributed equally.

Abstract

Introduction: The incidence of infants who are large-for-gestational-age (LGA) is on the rise in China, and its detrimental effects on health have received increasing attention. Diet-based interventions have the potential to reduce adverse birth outcomes, particularly in decreasing the occurrence of LGA infants. We aim to evaluate the effect of lipid-focused diet education based on the theories of behaviour change in pregnant women on maternal and offspring outcomes through a randomised controlled trial.

Methods and analysis: We have designed an open-label, parallel, multicentre randomised controlled trial in collaboration with three hospitals in Beijing, China.Pregnant women will be recruited before reaching 12 weeks of gestation and will be randomised in a 1:1:1 ratio into three arms: (1) online education arm, (2) pregnancy nutrition checklist and 'one-page flyer' arm and (3) routine antenatal education. The primary outcome LGA will be recorded at birth. Demographic information, physical activity, sleep and medical history will be collected through questionnaires and case cards prior to enrolment. Questionnaires will also be used to collect dietary behaviours and psychosocial factors of pregnant women at enrolment, at 24-28 weeks and 34-36 weeks of gestation. Additionally, information on breastfeeding and complementary food supplementation for infants and young children will be obtained through questionnaires. Physical development indicators of children and taste tests will be assessed 3 years after delivery.

Ethics and dissemination: The study has received ethical approval from the Capital Medical University Ethics Committee and other collaborating study centres. Informed consent will be introduced to pregnant women, and their consent will be obtained. The findings will be reported in relevant national and international academic conferences and peer-reviewed publications.

Trial registration number: ChiCTR2300071126.

Keywords: EPIDEMIOLOGIC STUDIES; Health Education; Obesity; PUBLIC HEALTH; Primary Prevention.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Child
Child, Preschool
Diet
Female
Humans
Infant, Newborn
Lipids
Pregnancy
Pregnancy Complications* / epidemiology
Pregnancy Outcome*
Pregnant Women
Randomized Controlled Trials as Topic
Weight Gain

Substances

Lipids

Associated data

ChiCTR/ChiCTR2300071126