Program to promote healthy weight gain during pregnancy
The Effects of Mobile Health Based Lifestyle Intervention on Gestational Weight Gain in Pregnant Women With Overweight and Obesity: A Randomized Controlled Trial
NA · Peking University · NCT06370533
This study is testing a program that helps overweight or obese pregnant women gain a healthy amount of weight and avoid gestational diabetes through a mix of online and in-person support.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Peking University (other) |
| Locations | 2 sites (Beijing, Beijing and 1 other locations) |
| Trial ID | NCT06370533 on ClinicalTrials.gov |
What this trial studies
This program evaluates the effectiveness of a multi-component lifestyle intervention aimed at promoting appropriate gestational weight gain and preventing gestational diabetes mellitus (GDM) among overweight or obese pregnant women. The intervention combines online and offline health education and utilizes mobile health technology through WeChat to engage participants. A total of 200 overweight or obese singleton pregnant women will be recruited and randomly assigned to either the intervention or control group, with follow-up assessments to measure pregnancy and neonatal outcomes. The study is designed to provide insights into effective strategies for managing weight gain during pregnancy.
Who should consider this trial
Good fit: Ideal candidates are overweight or obese pregnant women aged 18-40, between 8-14 weeks of gestation, who are capable of using smartphones and WeChat.
Not a fit: Patients with pre-existing severe health conditions or contraindications to physical activity may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could lead to healthier pregnancy outcomes and reduce the risk of complications associated with excessive weight gain.
How similar studies have performed: Previous studies have shown that lifestyle interventions can be effective in managing weight during pregnancy, but the specific mobile health approach in this study is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing and 1 other locations
- Tongzhou Maternal and Child Health-care Institution — Beijing, Beijing, China (NOT_YET_RECRUITING)
- W.F. Maternal and Child Health Hospital； — Weifang, Shandong, China (RECRUITING)
Study contacts
- Principal investigator: Haixue Wang, Doctor — Peking University
- Study coordinator: Haixue Wang, Doctor
- Email: gwwanghaixue@126.com
- Phone: 13041196856
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gestational Weight Gain, Overweight and Obesity