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RecruitingNCT05503849BIGISUpdated Sep 16, 2026

Born In Guangzhou Intervention Study

An interventional study of Lifestyle modification in Pregnancy Outcomes, Child Development and Pregnancy Complications, sponsored by Guangzhou Women and Children's Medical Center. Recruiting at 2 sites in China. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Guangzhou Women and Children's Medical Center · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,160
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Pregnancy Outcomes
  • Child Development
  • Pregnancy Complications
03

In context

Pregnancy Complications

411 studies on the registry are indexed under Pregnancy Complications; 113 are open to participants now.

This study's planned enrollment of 1,160 is above the median of 144 across 205 interventional studies indexed under Pregnancy Complications.

Browse Pregnancy Complications studies →

Lead sponsor

Guangzhou Women and Children's Medical Center is the lead sponsor of 58 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
1,160 participants (estimated)

Study arms

  • Experimental
    Proactive management during pregnancy

    A combination of dietary, physical activity and lifestyle modification.

    Behavioral: Lifestyle modification

  • No intervention
    Standard Care

    No additional intervention beyond standard care procedure.

Interventions

  • BehavioralLifestyle 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.)

06

What researchers measure

Primary outcomes

  1. Maternal gestational weight change

    Maternal weight prior to pregnancy (or within 8 weeks of pregnancy), at around 20, 26, 32 weeks' gestation, before delivery and one month postpartum will be determined by digital scales, changes in maternal weight during pregnancy will be recorded in kg.

    Time frame: From pregnancy until one month postpartum

  2. Newborn size

    Weight (kg) will be measured with digital scales and height/length (cm) will be measured in supine with tape, comparing against reference to derived gestational age and sex-specific growth parameter Z-scores. To identify whether the neonates was small/appropriate/large for gestational age.

    Time frame: Day 1 after birth

  3. Neonatal skinfold thickness (at birth)

    Measured with skinfold caliper, a summation of skinfold thickness at several body sites including triceps, biceps, subscapular, suprailiac and thigh, will be derived in cm.

    Time frame: Day 1 after birth

  4. Maternal blood lipid profile postpartum (3 years)

    Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L.

    Time frame: Three years after delivery

  5. Maternal blood glucose profile postpartum (3 years)

    Measured by autoanalyzer, blood glucose level in mmol/L.

    Time frame: Three years after delivery

  6. Maternal blood insulin profile postpartum (3 years)

    Measured by commercial ELIZA kit, total and free insulin in pmol/L.

    Time frame: Three years after delivery

  7. Child blood lipid profile (3 years)

    Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L.

    Time frame: At three years of age

  8. Child blood glucose profile (3 years)

    Measured by autoanalyzer, blood glucose level in mmol/L.

    Time frame: At three years of age

  9. Child blood insulin profile (3 years)

    Measured by commercial ELIZA kit, total and free insulin in pmol/L.

    Time frame: At three years of age

  10. Child growth parameters (3 years)

    Weight measured with digital scales in kg, length measured in standing position in cm, using weight and length to derived body mass index, comparing against age and sex-specific references for Z-score.

    Time frame: At three years of age

  11. Incidence of pregnancy complications

    Incidence of physician-diagnosed pregnancy complications, including gestational diabetes mellitus, hypertensive disorders

    Time frame: From 20 weeks' gestation until one month postpartum

Secondary outcomes

  1. Child skinfold thickness (6 months)

    Measured with skinfold caliper, a summation of skinfold thickness at several body sites including triceps, biceps, subscapular, suprailiac and thigh, will be derived in cm.

    Time frame: At six months of age

  2. Child skinfold thickness (1 year)

    Measured with skinfold caliper, a summation of skinfold thickness at several body sites including triceps, biceps, subscapular, suprailiac and thigh, will be derived in cm.

    Time frame: At one year of age

  3. Child skinfold thickness (3 years)

    Measured with skinfold caliper, a summation of skinfold thickness at several body sites including triceps, biceps, subscapular, suprailiac and thigh, will be derived in cm.

    Time frame: At three years of age

  4. Child skinfold thickness (6 years)

    Measured with skinfold caliper, a summation of skinfold thickness at several body sites including triceps, biceps, subscapular, suprailiac and thigh, will be derived in cm.

    Time frame: At six years of age

  5. Child growth parameters (6 months)

    Weight measured with digital scales in kg, length measured with tape in supine position in cm, using weight and length to derived body mass index, comparing against age and sex-specific references for Z-score.

    Time frame: At six months of age

  6. Child growth parameters (1 year)

    Weight measured with digital scales in kg, length measured with tape in supine position in cm, using weight and length to derived body mass index, comparing against age and sex-specific references for Z-score.

    Time frame: At one year of age

  7. Child growth parameters (6 years)

    Weight measured with digital scales in kg, length measured in standing position in cm, using weight and length to derived body mass index, comparing against age and sex-specific references for Z-score.

    Time frame: At six years of age

  8. Child blood lipid profile (6 years)

    Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L

    Time frame: At six years of age

  9. Child blood sugar profile (6 years)

    Measured by autoanalyzer, blood glucose level in mmol/L.

    Time frame: At six years of age

  10. Child blood insulin profile (6 years)

    Measured by commercial ELIZA kit, total and free insulin in pmol/L.

    Time frame: At six years of age

  11. Neurological development of child (1 year)

    Assessed by using Gesell testing, which measures the child's cognitive, language, motor (gross \& fine) and social-emotional responses. Higher score in each domain is desired, there is no upper limit. Overall score of less than 86 indicates suspected developmental retardation.

    Time frame: At one year of age

  12. Neurological development of child (3 years)

    Assessed by Ages \& Stages Questionnaires, including adaptive, motor (gross \& fine), language, and social function domains, overall score being less than -2SD of age specific mean indicates suspected developmental retardation.

    Time frame: At three years of age

  13. Maternal hand grip strength during pregnancy

    Measured by high precision digital hand dynamometer, in kg

    Time frame: Between 32-34 weeks' gestation

  14. Maternal hand grip strength after delivery

    Measured by high precision digital hand dynamometer, in kg

    Time frame: At one month postpartum

  15. Maternal body composition postpartum

    Measured by dual-energy X-ray absorptiometry by trained physician, fat mass (kg), fat free mass (kg), and relative proportion (%) and distribution of fat mass will be described.

    Time frame: At one month postpartum

  16. Maternal blood lipid profile postpartum (6 years)

    Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L.

    Time frame: Six years after delivery

  17. Maternal blood sugar profile postpartum (6 years)

    Measured by autoanalyzer, blood glucose level in mmol/L.

    Time frame: Six years after delivery

  18. Maternal blood insulin profile postpartum (6 years)

    Measured by commercial ELIZA kit, total and free insulin in pmol/L.

    Time frame: Six years after delivery

07

Study locations

2 of 2 sites recruiting
  • Fuying Campus, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China
    Guangzhou, China
    Recruiting
  • Zhujiang new town campus, Guangzhou Women and Children&#39;s Medical Center, China
    Guangzhou, China
    Recruiting
08

References and documents

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. PubMed 28321694 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Sep 2030, 74 months after the start.

Of 119 non-industry interventional studies with no phase under Pregnancy Complications, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 74 months is above that.

Counting every sponsor, half of 119 studies reached it within 26 months; a quarter within 12 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 9, 2022
First posted
Aug 17, 2022
StartActual
Jul 22, 2024
Primary completionEst.
Sep 2030
CompletionEst.
Sep 2032
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05503849
Lead sponsor
Guangzhou Women and Children's Medical Center
Responsible party
Xiu Qiu (Director of the Department of Women's Health, Guangzhou Women and Children's Medical Center) — Principal investigator
First posted
Aug 17, 2022
Start date
Jul 22, 2024
Primary completion
Sep 2030 (estimated)
Completion
Sep 2032 (estimated)
Last update
Sep 16, 2026

Study contacts

Qiu Qiu, Dr.
Contact
qxiu0161@163.com
86+02038367159
Songying Shen, Msc.
Contact
86+02038367160

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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