Recruiting NCT05503849
Born In Guangzhou Intervention Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lifestyle modification.
- Who it may be relevant to
- Registry conditions: Pregnancy Outcomes, Child Development, Pregnancy Complications. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral Lifestyle modification
This lifestyle modification aiming to provide proactive health management during pregnancy, which contains the following: 1) balanced dietary intake based on the Chinese Dietary Guideline; 2) sufficient physical activity; 3) changes in lifestyles (e.g. sleep, sun exposure etc.)
Primary outcome measures
- Maternal gestational weight change [Time frame: From pregnancy until one month postpartum]
- Newborn size [Time frame: Day 1 after birth]
- Neonatal skinfold thickness (at birth) [Time frame: Day 1 after birth]
- Maternal blood lipid profile postpartum (3 years) [Time frame: Three years after delivery]
- Maternal blood glucose profile postpartum (3 years) [Time frame: Three years after delivery]
- Maternal blood insulin profile postpartum (3 years) [Time frame: Three years after delivery]
- Child blood lipid profile (3 years) [Time frame: At three years of age]
- Child blood glucose profile (3 years) [Time frame: At three years of age]
- Child blood insulin profile (3 years) [Time frame: At three years of age]
- Child growth parameters (3 years) [Time frame: At three years of age]
Secondary outcome measures (12)
- Child skinfold thickness (6 months) [Time frame: At six months of age]
- Child skinfold thickness (1 year) [Time frame: At one year of age]
- Child skinfold thickness (3 years) [Time frame: At three years of age]
- Child skinfold thickness (6 years) [Time frame: At six years of age]
- Child growth parameters (6 months) [Time frame: At six months of age]
- Child growth parameters (1 year) [Time frame: At one year of age]
- Child growth parameters (6 years) [Time frame: At six years of age]
- Child blood lipid profile (6 years) [Time frame: At six years of age]
- Child blood sugar profile (6 years) [Time frame: At six years of age]
- Child blood insulin profile (6 years) [Time frame: At six years of age]
- Neurological development of child (1 year) [Time frame: At one year of age]
- Neurological development of child (3 years) [Time frame: At three years of age]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
China · 2 centers
- Fuying Campus, Guangzhou Women and Children's Medical Center, Guangzhou Medical University — Guangzhou
- Zhujiang new town campus, Guangzhou Women and Children's Medical Center, China — Guangzhou
Publications
- 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. PMID 28321694
Identifiers
NCT: NCT05503849 · 2022390B00