Born In Guangzhou Intervention Study (BIGIS)

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 Overview

• Status: Not yet recruiting
• Conditions: Pregnancy Complications; Child Development; Pregnancy Outcomes
• Intervention / Treatment: Behavioral: Lifestyle modification

• Study Type: Interventional
• Enrollment (Estimated): 1160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiu Qiu; Phone Number: 86-020-38367160; Email: xiu.qiu@bigcs.org

Study Locations

• China
  • Guangzhou, China
    • Guangzhou Women and Children's Medical Center, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Proactive management during pregnancy; A combination of dietary, physical activity and lifestyle modification.	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.)
No Intervention: Standard Care; No additional intervention beyond standard care procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Three years after delivery
Maternal blood glucose profile postpartum (3 years)	Measured by autoanalyzer, blood glucose level in mmol/L.	Three years after delivery
Maternal blood insulin profile postpartum (3 years)	Measured by commercial ELIZA kit, total and free insulin in pmol/L.	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.	At three years of age
Child blood glucose profile (3 years)	Measured by autoanalyzer, blood glucose level in mmol/L.	At three years of age
Child blood insulin profile (3 years)	Measured by commercial ELIZA kit, total and free insulin in pmol/L.	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.	At three years of age
Incidence of pregnancy complications	Incidence of physician-diagnosed pregnancy complications, including gestational diabetes mellitus, hypertensive disorders	From 20 weeks' gestation until one month postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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	At six years of age
Child blood sugar profile (6 years)	Measured by autoanalyzer, blood glucose level in mmol/L.	At six years of age
Child blood insulin profile (6 years)	Measured by commercial ELIZA kit, total and free insulin in pmol/L.	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.	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.	At three years of age
Maternal hand grip strength during pregnancy	Measured by high precision digital hand dynamometer, in kg	Between 32-34 weeks' gestation
Maternal hand grip strength after delivery	Measured by high precision digital hand dynamometer, in kg	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.	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.	Six years after delivery
Maternal blood sugar profile postpartum (6 years)	Measured by autoanalyzer, blood glucose level in mmol/L.	Six years after delivery
Maternal blood insulin profile postpartum (6 years)	Measured by commercial ELIZA kit, total and free insulin in pmol/L.	Six years after delivery

Collaborators and Investigators

• Sponsor: Guangzhou Women and Children's Medical Center
• Investigators: Principal Investigator: Xiu Qiu, Guangzhou Women And Children's Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2032

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 14, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications
• Other Study ID Numbers: 2022390B00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No