NCT05503849

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,160

participants targeted

Target at P75+ for not_applicable

Timeline
77mo left

Started Jul 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Jul 2024Sep 2032

First Submitted

Initial submission to the registry

August 9, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed
1.9 years until next milestone

Study Start

First participant enrolled

July 22, 2024

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2030

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2032

Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

6.1 years

First QC Date

August 9, 2022

Last Update Submit

April 7, 2025

Conditions

Pregnancy OutcomesChild DevelopmentPregnancy Complications

Outcome Measures

Primary Outcomes (11)

  • 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 Outcomes (18)

  • Child skinfold thickness (6 months)

    At six months of age

  • Child skinfold thickness (1 year)

    At one year of age

  • Child skinfold thickness (3 years)

    At three years of age

  • Child skinfold thickness (6 years)

    At six years of age

  • Child growth parameters (6 months)

    At six months of age

  • +13 more secondary outcomes

Study Arms (2)

Proactive management during pregnancy

EXPERIMENTAL

A combination of dietary, physical activity and lifestyle modification.

Behavioral: Lifestyle modification

Standard Care

NO INTERVENTION

No additional intervention beyond standard care procedure.

Interventions

Lifestyle modificationBEHAVIORAL

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.)

Proactive management during pregnancy

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Related Publications (1)

  • 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: 28321694BACKGROUND

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Qiu Qiu, Dr.

CONTACT

86+02038367159qxiu0161@163.com

Songying Shen, Msc.

CONTACT

86+02038367160

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Department of Women's Health

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 17, 2022

Study Start

July 22, 2024

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2032

Last Updated

April 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)