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