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Born In Guangzhou Intervention Study (BIGIS)

Primary Purpose

Pregnancy Outcomes, Child Development, Pregnancy Complications

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lifestyle modification
Sponsored by
Guangzhou Women and Children's Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy Outcomes

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Guangzhou Women and Children's Medical Center, China

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Proactive management during pregnancy

Standard Care

Arm Description

A combination of dietary, physical activity and lifestyle modification.

No additional intervention beyond standard care procedure.

Outcomes

Primary Outcome Measures

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.
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.
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.
Maternal blood lipid profile postpartum (3 years)
Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L.
Maternal blood glucose profile postpartum (3 years)
Measured by autoanalyzer, blood glucose level in mmol/L.
Maternal blood insulin profile postpartum (3 years)
Measured by commercial ELIZA kit, total and free insulin in pmol/L.
Child blood lipid profile (3 years)
Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L.
Child blood glucose profile (3 years)
Measured by autoanalyzer, blood glucose level in mmol/L.
Child blood insulin profile (3 years)
Measured by commercial ELIZA kit, total and free insulin in pmol/L.
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.
Incidence of pregnancy complications
Incidence of physician-diagnosed pregnancy complications, including gestational diabetes mellitus, hypertensive disorders

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
Child blood lipid profile (6 years)
Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L
Child blood sugar profile (6 years)
Measured by autoanalyzer, blood glucose level in mmol/L.
Child blood insulin profile (6 years)
Measured by commercial ELIZA kit, total and free insulin in pmol/L.
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.
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.
Maternal hand grip strength during pregnancy
Measured by high precision digital hand dynamometer, in kg
Maternal hand grip strength after delivery
Measured by high precision digital hand dynamometer, in kg
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.
Maternal blood lipid profile postpartum (6 years)
Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L.
Maternal blood sugar profile postpartum (6 years)
Measured by autoanalyzer, blood glucose level in mmol/L.
Maternal blood insulin profile postpartum (6 years)
Measured by commercial ELIZA kit, total and free insulin in pmol/L.

Full Information

First Posted
August 9, 2022
Last Updated
September 11, 2023
Sponsor
Guangzhou Women and Children's Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05503849
Brief Title
Born In Guangzhou Intervention Study
Acronym
BIGIS
Official Title
Born In Guangzhou Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2030 (Anticipated)
Study Completion Date
September 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Women and Children's Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Outcomes, Child Development, Pregnancy Complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
1160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Proactive management during pregnancy
Arm Type
Experimental
Arm Description
A combination of dietary, physical activity and lifestyle modification.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
No additional intervention beyond standard care procedure.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle modification
Intervention Description
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 Measure Information:
Title
Maternal gestational weight change
Description
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
Title
Newborn size
Description
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
Title
Neonatal skinfold thickness (at birth)
Description
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
Title
Maternal blood lipid profile postpartum (3 years)
Description
Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L.
Time Frame
Three years after delivery
Title
Maternal blood glucose profile postpartum (3 years)
Description
Measured by autoanalyzer, blood glucose level in mmol/L.
Time Frame
Three years after delivery
Title
Maternal blood insulin profile postpartum (3 years)
Description
Measured by commercial ELIZA kit, total and free insulin in pmol/L.
Time Frame
Three years after delivery
Title
Child blood lipid profile (3 years)
Description
Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L.
Time Frame
At three years of age
Title
Child blood glucose profile (3 years)
Description
Measured by autoanalyzer, blood glucose level in mmol/L.
Time Frame
At three years of age
Title
Child blood insulin profile (3 years)
Description
Measured by commercial ELIZA kit, total and free insulin in pmol/L.
Time Frame
At three years of age
Title
Child growth parameters (3 years)
Description
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
Title
Incidence of pregnancy complications
Description
Incidence of physician-diagnosed pregnancy complications, including gestational diabetes mellitus, hypertensive disorders
Time Frame
From 20 weeks' gestation until one month postpartum
Secondary Outcome Measure Information:
Title
Child skinfold thickness (6 months)
Description
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
Title
Child skinfold thickness (1 year)
Description
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
Title
Child skinfold thickness (3 years)
Description
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
Title
Child skinfold thickness (6 years)
Description
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
Title
Child growth parameters (6 months)
Description
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
Title
Child growth parameters (1 year)
Description
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
Title
Child growth parameters (6 years)
Description
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
Title
Child blood lipid profile (6 years)
Description
Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L
Time Frame
At six years of age
Title
Child blood sugar profile (6 years)
Description
Measured by autoanalyzer, blood glucose level in mmol/L.
Time Frame
At six years of age
Title
Child blood insulin profile (6 years)
Description
Measured by commercial ELIZA kit, total and free insulin in pmol/L.
Time Frame
At six years of age
Title
Neurological development of child (1 year)
Description
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
Title
Neurological development of child (3 years)
Description
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
Title
Maternal hand grip strength during pregnancy
Description
Measured by high precision digital hand dynamometer, in kg
Time Frame
Between 32-34 weeks' gestation
Title
Maternal hand grip strength after delivery
Description
Measured by high precision digital hand dynamometer, in kg
Time Frame
At one month postpartum
Title
Maternal body composition postpartum
Description
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
Title
Maternal blood lipid profile postpartum (6 years)
Description
Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L.
Time Frame
Six years after delivery
Title
Maternal blood sugar profile postpartum (6 years)
Description
Measured by autoanalyzer, blood glucose level in mmol/L.
Time Frame
Six years after delivery
Title
Maternal blood insulin profile postpartum (6 years)
Description
Measured by commercial ELIZA kit, total and free insulin in pmol/L.
Time Frame
Six years after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiu Qiu
Phone
86-020-38367160
Email
xiu.qiu@bigcs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiu Qiu
Organizational Affiliation
Guangzhou Women and Children's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou Women and Children's Medical Center, China
City
Guangzhou
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28321694
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.
Results Reference
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Born In Guangzhou Intervention Study

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