Clinical trial NCT05503849: Born In Guangzhou Intervention Study
Official title: Born In Guangzhou Intervention Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Outcomes
Child Development
Pregnancy Complications
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 1160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective of this study is to test the efficacy of an intervention package (dietary, physical and lifestyle modification) during pregnancy in improving the clinical outcomes of mother-infant dyads.


Eligibility criteria: Inclusion Criteria:

* Pregnant women attending prenatal care at Guangzhou Women and Children's Medical Center (GWCMC) \<20 weeks' gestation
* Pregnant women plan to deliver at GWCMC
* Pregnant women intend to reside in Guangzhou for at least 3 years

Exclusion Criteria:

* Multiple pregnancies
* Existing medical conditions (uncontrolled diabetes, hypertension or thyroid disease; other serious cardiovascular diseases, respiratory or systematic disorders)
* Use of drugs (aspirin, metformin, low molecular weight heparin)
* Women with reading and/or writing difficulties
* Women with serious mental disorders
* Women with eating disorders

Primary outcomes:
measure: Maternal gestational weight change
timeFrame: From pregnancy until one month postpartum
measure: Newborn size
timeFrame: Day 1 after birth
measure: Neonatal skinfold thickness (at birth)
timeFrame: Day 1 after birth
measure: Maternal blood lipid profile postpartum (3 years)
timeFrame: Three years after delivery
measure: Maternal blood glucose profile postpartum (3 years)
timeFrame: Three years after delivery
measure: Maternal blood insulin profile postpartum (3 years)
timeFrame: Three years after delivery
measure: Child blood lipid profile (3 years)
timeFrame: At three years of age
measure: Child blood glucose profile (3 years)
timeFrame: At three years of age
measure: Child blood insulin profile (3 years)
timeFrame: At three years of age
measure: Child growth parameters (3 years)
timeFrame: At three years of age
measure: Incidence of pregnancy complications
timeFrame: From 20 weeks' gestation until one month postpartum
Secondary outcomes:
measure: Child skinfold thickness (6 months)
timeFrame: At six months of age
measure: Child skinfold thickness (1 year)
timeFrame: At one year of age
measure: Child skinfold thickness (3 years)
timeFrame: At three years of age
measure: Child skinfold thickness (6 years)
timeFrame: At six years of age
measure: Child growth parameters (6 months)
timeFrame: At six months of age
measure: Child growth parameters (1 year)
timeFrame: At one year of age
measure: Child growth parameters (6 years)
timeFrame: At six years of age
measure: Child blood lipid profile (6 years)
timeFrame: At six years of age
measure: Child blood sugar profile (6 years)
timeFrame: At six years of age
measure: Child blood insulin profile (6 years)
timeFrame: At six years of age
measure: Neurological development of child (1 year)
timeFrame: At one year of age
measure: Neurological development of child (3 years)
timeFrame: At three years of age
measure: Maternal hand grip strength during pregnancy
timeFrame: Between 32-34 weeks' gestation
measure: Maternal hand grip strength after delivery
timeFrame: At one month postpartum
measure: Maternal body composition postpartum
timeFrame: At one month postpartum
measure: Maternal blood lipid profile postpartum (6 years)
timeFrame: Six years after delivery
measure: Maternal blood sugar profile postpartum (6 years)
timeFrame: Six years after delivery
measure: Maternal blood insulin profile postpartum (6 years)
timeFrame: Six years after delivery
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: Fuying Campus, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China
city: Guangzhou
country: China
facility: Zhujiang new town campus, Guangzhou Women and Children&#39;s Medical Center, China
Study officials:
References:
citation: Qiu X, Lu JH, He JR, Lam KH, Shen SY, Guo Y, Kuang YS, Yuan MY, Qiu L, Chen NN, Lu MS, Li WD, Xing YF, Zhou FJ, Bartington S, Cheng KK, Xia HM. The Born in Guangzhou Cohort Study (BIGCS). Eur J Epidemiol. 2017 Apr;32(4):337-346. doi: 10.1007/s10654-017-0239-x. Epub 2017 Mar 20.