Healthy Gestational Weight Gain Programme (NCT06370533) | Clinical Trial Compass
CompletedNot Applicable
Healthy Gestational Weight Gain Programme
China200 participantsStarted 2024-04-19
Plain-language summary
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.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Total gestational weight gain
Timeframe: From pre-pregnancy to gestational week 32-36
2
Gestational weight gain before OGTT screening
Timeframe: From pre-pregnancy to midterm (24-28 weeks)
✕. 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
✕. Special dietary needs (e.g. , vegetarianism)
✕. 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
✕. Participated in other clinical trials within 6 months