Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT06370533
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT06370533
Study Brief:
Protocol Section:
NCT06370533