nctId: NCT06370533 id: HGWG-pro briefTitle: Healthy Gestational Weight Gain Programme overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-01-31 date: 2026-01-31 date: 2024-04-17 date: 2024-04-19 name: Peking University class: OTHER name: W.F. Maternal and Child Health Hospital briefSummary: 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 BMI≥24 kg/m2) during the first trimester of pregnancy from Weifang maternal and Child Health Center, Shandong Province, China. 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 10-14 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 smart watch. 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. conditions: Gestational Weight Gain conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: behavioral interventions measure: Total gestational weight gain measure: Gestational weight gain before OGTT screening measure: Weekly rate of gestational weight gain between study clinical assessments measure: Proportion of women who exceed the Chinese reference/2009 IOM guidelines for total gestational weight gain measure: Proportion of women who exceed the Chinese reference/2009 IOM guidelines for appropriate weekly rate of GWG in second and third trimester measure: Proportion of women who exceed the Chinese reference/2009 IOM guidelines for appropriate weekly rate of GWG before OGTT screening measure: Rate of Gestational Diabetes Mellitus diagnosed according to International Association of Diabetes and Pregnancy Study Group (IADPSG) criteria measure: Rate of Preeclampsia/Gestational hypertension measure: Rate of Cesarean Section measure: Absolute/Mean Infant birth weight measure: Rate of Macrosomia measure: Absolute/Mean Apgar scores at 1 min or 5 min measure: Change of Blood pressure measure: Change of body fat percentage (%) measure: Change of fat free mass (kg) measure: Change of muscle mass (kg) measure: Change of handgrip strength (kg) measure: Change of Attitude and knowledge measure: Change of dietary intake measure: Change of physical activity measure: Change of sleep quality measure: Change of Quality of life (12-Item Short Form Survey, SF-12) measure: Incidence of depression measure: Incidence of anxiety measure: The Change of Self-efficacy score (General Self-Efficacy Scale, GSES) measure: The stage of change related to gestational weight control behavior measure: Rate of Postpartum weight retention measure: Absolute/mean offspring weight in kilograms measure: Absolute/mean offspring height in centimetres measure: Absolute/mean offspring head circumference sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False