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Search / Trial NCT06370533

Healthy Gestational Weight Gain Programme

Launched by PEKING UNIVERSITY · Apr 14, 2024

Trial Information

Current as of June 17, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial, called the Healthy Gestational Weight Gain Programme, is studying how a special lifestyle program can help overweight or obese pregnant women gain a healthy amount of weight during pregnancy. The program includes education about healthy eating, exercise, and regular check-ins through phone calls and a mobile app called WeChat. The goal is to see if these lifestyle changes can lead to better pregnancy outcomes, like preventing diabetes and ensuring a healthy delivery for both the mother and baby.

To participate, women must be between 18 and 40 years old, pregnant with one baby, and have a body mass index (BMI) that falls within the overweight or obese range. They should be between 8 to 14 weeks pregnant and comfortable using smartphones for communication. Participants will be randomly assigned to either the lifestyle program or a control group that receives standard prenatal care. Throughout the study, which lasts about six months, participants will receive support and monitoring to help them make healthy choices.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • 1. At 8-14 weeks of gestation
  • 2. Overweight or obese (pre-pregnancy 40 kg/m2≥BMI≥24 kg/m2) based on BMI recommendations of the Group of China Obesity Task Force of the Chinese Ministry of Health accounting for interracial differences (overweight BMI 24-28 kg/m2 and obese BMI≥28kg/m2)
  • 3. 18-40 years of age
  • 4. Singleton pregnant
  • 5. Skilled at using smartphones and WeChat during pregnancy
  • 6. Attend regular antenatal care and plan delivery at W.F. Maternal and Child Health Hospital or Tongzhou Maternal and Child Health-care Institution of Beijing
  • 7. No contraindications to physical activity according to Physical Activity Readiness Questionnaire (PAR-Q)
  • 8. Willing to be randomized and cooperate with research and regular follow-up visits and sign informed consent.
  • Exclusion Criteria:
  • 1. Pre-pregnancy hypertension, severe cardiovascular and cerebrovascular diseases, respiratory disease, hepatic and renal disease, malignant tumors, systemic lupus erythematosus, thyroid disease, severe anemia, and other chronic consumptive diseases.
  • 2. Cervical insufficiency (historical painless cervical dilation leading to recurrent second-trimester births in the absence of other causes; dilated cervix on manual or speculum examination, etc.), multiple pregnancy, or continuous vaginal bleeding, etc.
  • 3. Diabetes before pregnancy
  • 4. Special dietary needs (e.g. , vegetarianism)
  • 5. Severe psychiatric disorders (serious mental health disorders including depression, anxiety, bipolar disorders, etc.)
  • 6. Cognitive impairment, visual impairment or hearing impairment
  • 7. History of bariatric surgery or surgical history involving important organs within 3 months
  • 8. Participated in other clinical trials within 6 months

About Peking University

Peking University is a prestigious institution located in Beijing, China, recognized for its commitment to advancing medical research and education. As a clinical trial sponsor, Peking University leverages its extensive academic resources and collaborative networks to drive innovative healthcare solutions. The university's focus on rigorous scientific methodologies and adherence to ethical standards ensures the integrity and reliability of its clinical research initiatives. By fostering interdisciplinary partnerships, Peking University aims to translate groundbreaking discoveries into tangible health benefits, contributing to the global advancement of medical science.

Locations

Beijing, Beijing, China

Weifang, Shandong, China

Patients applied

0 patients applied

Trial Officials

Haixue Wang, Doctor

Principal Investigator

Peking University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported