Pregnancy OutcomesBIGISNCT05503849
Born In Guangzhou Intervention Study
A study testing Lifestyle modification in people with Pregnancy Outcomes and Child Development, run by Guangzhou Women and Children's Medical Center at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Outcomes, Child Development, Pregnancy Complications
- What is being tested?
- Lifestyle modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,160 participants
- Where
- 2 sitesChina
- Study dates
- 22 Jul 2024to Sep 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Songying Shen, Msc. contact
China2 sites, 2 recruiting
- Recruiting
Fuying Campus, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China
Guangzhou
Xiu Qiu, 086-020-38367160, qxiu0161@163.com
- Recruiting
Zhujiang new town campus, Guangzhou Women and Children's Medical Center, China
Guangzhou
Xiu Qiu, MD,PhD, 86-020-38367160, xiu.qiu@bigcs.org
Jian-Rong He, MD, PhD, 86-020-38367160, jianrong.he@bigcs.org
About this study
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.
- Being tested
- Lifestyle modification
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle modificationBehavioural
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.)
| Study group | Role | What they receive |
|---|---|---|
| Proactive management during pregnancy | Experimental | A combination of dietary, physical activity and lifestyle modification. Receives: Behavioral: Lifestyle modification |
| Standard Care | No intervention | No additional intervention beyond standard care procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From pregnancy until one month postpartum
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.
Measured: Day 1 after birth
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.
Measured: Day 1 after birth
Maternal blood lipid profile postpartum (3 years)
Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L.
Measured: Three years after delivery
Maternal blood glucose profile postpartum (3 years)
Measured by autoanalyzer, blood glucose level in mmol/L.
Measured: Three years after delivery
Maternal blood insulin profile postpartum (3 years)
Measured by commercial ELIZA kit, total and free insulin in pmol/L.
Measured: Three years after delivery
Child blood lipid profile (3 years)
Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L.
Measured: At three years of age
Child blood glucose profile (3 years)
Measured by autoanalyzer, blood glucose level in mmol/L.
Measured: At three years of age
Child blood insulin profile (3 years)
Measured by commercial ELIZA kit, total and free insulin in pmol/L.
Measured: At three years of age
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.
Measured: At three years of age
Incidence of pregnancy complications
Incidence of physician-diagnosed pregnancy complications, including gestational diabetes mellitus, hypertensive disorders
Measured: From 20 weeks' gestation until one month postpartum
Secondary outcomes (18)
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.
Measured: At six months of age
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.
Measured: At one year of age
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.
Measured: At three years of age
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.
Measured: At six years of age
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.
Measured: At six months of age
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.
Measured: At one year of age
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.
Measured: At six years of age
Child blood lipid profile (6 years)
Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L
Measured: At six years of age
Child blood sugar profile (6 years)
Measured by autoanalyzer, blood glucose level in mmol/L.
Measured: At six years of age
Child blood insulin profile (6 years)
Measured by commercial ELIZA kit, total and free insulin in pmol/L.
Measured: At six years of age
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.
Measured: At one year of age
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.
Measured: At three years of age
Maternal hand grip strength during pregnancy
Measured by high precision digital hand dynamometer, in kg
Measured: Between 32-34 weeks' gestation
Maternal hand grip strength after delivery
Measured by high precision digital hand dynamometer, in kg
Measured: At one month postpartum
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.
Measured: At one month postpartum
Maternal blood lipid profile postpartum (6 years)
Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L.
Measured: Six years after delivery
Maternal blood sugar profile postpartum (6 years)
Measured by autoanalyzer, blood glucose level in mmol/L.
Measured: Six years after delivery
Maternal blood insulin profile postpartum (6 years)
Measured by commercial ELIZA kit, total and free insulin in pmol/L.
Measured: Six years after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start22 Jul 2024
- Primary completionSep 2030 (estimated)
- Study completionSep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 1,160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiu Qiu, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503849
- Sponsor's protocol ID
- 2022390B00
- Acronym
- BIGIS
- Status last verified
- Sep 2026
- First submitted
- 9 Aug 2022
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Born In Guangzhou Intervention Study
- ClinicalTrials.gov ID
- NCT05503849
- Acronym / sponsor ID
- BIGIS / 2022390B00
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,160 participants (estimated)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2032 (estimated)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proactive management during pregnancy | Experimental | Behavioral: Lifestyle modificationA combination of dietary, physical activity and lifestyle modification. |
| Standard Care | No intervention | –No additional intervention beyond standard care procedure. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle modificationThis 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.) | Behavioural | Proactive management during pregnancy |
Primary outcome
Maternal gestational weight change
Time frame: From pregnancy until one month postpartum
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.
Newborn size
Time frame: Day 1 after birth
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.
Neonatal skinfold thickness (at birth)
Time frame: Day 1 after 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.
Maternal blood lipid profile postpartum (3 years)
Time frame: Three years after delivery
Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L.
Maternal blood glucose profile postpartum (3 years)
Time frame: Three years after delivery
Measured by autoanalyzer, blood glucose level in mmol/L.
Maternal blood insulin profile postpartum (3 years)
Time frame: Three years after delivery
Measured by commercial ELIZA kit, total and free insulin in pmol/L.
Child blood lipid profile (3 years)
Time frame: At three years of age
Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L.
Child blood glucose profile (3 years)
Time frame: At three years of age
Measured by autoanalyzer, blood glucose level in mmol/L.
Child blood insulin profile (3 years)
Time frame: At three years of age
Measured by commercial ELIZA kit, total and free insulin in pmol/L.
Child growth parameters (3 years)
Time frame: At three years of age
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.
Incidence of pregnancy complications
Time frame: From 20 weeks' gestation until one month postpartum
Incidence of physician-diagnosed pregnancy complications, including gestational diabetes mellitus, hypertensive disorders
18 secondary outcomes
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
Maternal hand grip strength during pregnancy
Time frame: Between 32-34 weeks' gestation
Maternal hand grip strength after delivery
Time frame: At one month postpartum
Maternal body composition postpartum
Time frame: At one month postpartum
Maternal blood lipid profile postpartum (6 years)
Time frame: Six years after delivery
Maternal blood sugar profile postpartum (6 years)
Time frame: Six years after delivery
Maternal blood insulin profile postpartum (6 years)
Time frame: Six years after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 28321694Qiu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Songying Shen, Msc. contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle modification in people with Pregnancy Outcomes and Child Development, run by Guangzhou Women and Children's Medical Center at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiu Qiu, Dr. (86+02038367159, qxiu0161@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal gestational weight change (time frame: From pregnancy until one month postpartum). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05503849, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.