NCT06370533Completed
Healthy Gestational Weight Gain Programme
The Effects of Mobile Health Based Lifestyle Intervention on Gestational Weight Gain in Pregnant Women With Overweight and Obesity: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
This study aims to evaluate the efficacy of a multi-component lifestyle interventions during pregnancy on promoting appropriate gestational weight gain, preventing GDM, and improving pregnancy, delivery, and neonatal outcomes among overweight or obese pregnant women. The intervention strategies are developed based on the transtheoretical model and mobile health (via WeChat Public Account in smartphone), and will be conducted online and offline. This study will recruit and follow-up 200 overweight or obese singleton pregnant women (pre-pregnancy 24kg/m2≤BMI≤40 kg/m2) during the first trimester of pregnancy from Weifang Maternal and Child Health Hospital, Shandong Province, China, and Tongzhou Maternal and Child Health-care Institution, Beijing, China, with 100 pregnancy women in each institution. The 200 overweight or obese pregnant women will be randomly allocated at a 1:1 ratio to either the intervention or control group, stratified by the categorical variables of age, BMI and parity. Participants in the control group will be provided usual prenatal care. The lifestyle intervention will last for approximately 6 months (from 10-14 weeks to 32-36 weeks of gestation). Follow-up timepoints included 8-14 weeks of gestation, 24-28 weeks of gestation, 32-36 weeks of gestation. The interventions are composed of health education related to gestational weight gain and healthy lifestyles, diet modification, active physical activity, regular individual in-person and telephone sessions, diet behavior monitoring, physical activity monitoring, and weight monitoring with Huawei Wristband and WeChat Public Account. The hypothesis is that lifestyle interventions based on the transtheoretical model and mobile health will result in more appropriate gestational weight gain and lower risk of adverse pregnancy outcomes compared with usual care.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 200 (actual)
- First submitted
- 31 Mar 2024
- Start date
- 19 Apr 2024
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- Peking University
- Diseases
- Obesity
- NCT number
- NCT06370533
What you commit to
- Study type: Interventional
- Participants enrolled: 200
- From 19 Apr 2024 to the primary completion date, 31 Mar 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- 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.
- Diabetes before pregnancy
- Severe psychiatric disorders (serious mental health disorders including depression, anxiety, bipolar disorders, etc.)
- Cognitive impairment, visual impairment or hearing impairment
- History of bariatric surgery or surgical history involving important organs within 3 months
Other
- Special dietary needs (e.g. , vegetarianism)
- Participated in other clinical trials within 6 months
Who the study is looking for
- At 8-14 weeks of gestation
- 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)
- 18-40 years of age
- Singleton pregnant
- Skilled at using smartphones and WeChat during pregnancy
- 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
- No contraindications to physical activity according to Physical Activity Readiness Questionnaire (PAR-Q)
- Willing to be randomized and cooperate with research and regular follow-up visits and sign informed consent.
Age in the registry: 18 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tongzhou Maternal and Child Health-care Institution Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| W.F. Maternal and Child Health Hospital； Coordinator of this site? Confirm its status | Weifang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.