Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370533
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-03-31
Brief Title:
Healthy Gestational Weight Gain Programme
Sponsor:
Peking University
Organization:
Peking University
Study Overview
Official Title:
The Effects of Mobile Health Based Lifestyle Intervention on Gestational Weight Gain in Pregnant Women With Overweight and Obesity A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 24kgm2BMI40 kgm2 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 11 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
Detailed Description:
Overweight and obesity is a major public health problem among women in reproductive age Excessive gestational weight gain EGWG among this group is becoming a worldwide epidemic over recent decades EGWG is associated with adverse outcomes including increased risk of developing gestational diabetes mellitus GDM cesarean section hypertensive disorders of pregnancy HDP elevated infant birth weight and adiposity and increased risk of metabolic syndrome and childhood obesity in offspring Therefore interventions are needed to help overweight and obese pregnant women to control GWG
Lifestyle intervention has been proved effective on weight management during pregnancy However the effects of interventions on controlling overweight and obese womens GWG are inconsistent Traditional face-to-face counseling are less cost effective Effective intervention models based on Mobile health that can be scaled up are scarce Thus this randomized controlled trial aims to identify firstly whether the mobile health lifestyle interventions will be effective on improving gestational weight gain and preventing GDM among overweight or obese pregnant women secondly whether the intervention will be beneficial for improving pregnancy outcomes delivery outcomes neonatal outcomes metabolic indicators body composition indicators etc among overweight or obese pregnant women
The interventions are composed of health education online and offline health education on recommended gestational weight gain prenatal dietary guidance and physical activity recommendation diet behavior modification 8 core dietary goal setting and monitoring weekly active physical activity 150 min per week of moderate-to vigorous-intensity physical activity including aerobic exercise brisk walking and resistance exercise goal of 6000 stepsday regular face to face or telephone sessions lifestyle diet and physical activity behavior and weight monitoring via Huawei Wristband or WeChat Public Account Tailoring of the intervention will be guided by the transtheoretical model A total of 200 overweight or obese singleton pregnant women of 8-14 weeks of gestation will be recruited and they will be randomly allocated at a 11 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
Women in both study arms will attend three research appointments at 8-14 weeks baseline24-28 weeks midterm and 32-36 weeks terminal of gestation for data collection via questionnaires physical measurements and clinical laboratory examination Information on demography socioeconomic status medical and family history obstetric history current pregnancy information smoking consumption of alcohol attitude and knowledge about GWG diet and exercise habits sleep situation quality of life mental health depression anxiety social support self-efficacy etc will be collected with questionnaires and interviews by research stuff Physical measurements including weight height blood pressure and body composition using bioelectrical impedance BIA will be obtained using standardized methods Laboratory tests performed in conjunction with antenatal visits include a 75 g 2-hour oral glucose tolerance test OGTT Data on mode of delivery gestational age at birth birth weight Apgar scores perinatal complications etc will be obtained from patient records In addition blood and urine samples will be drawn at three appointments and a sample of cord blood will be collected at birth Maternal postpartum weight 42 days6 months1 year after delivery will be obtained through routine physical examination or telephone follow-up Offspring physical growth indicators such as height weight head circumference etc will be collected from routine physical examination in 42 days 6 months and 12 months of age
Lifestyle intervention has been proved effective on weight management during pregnancy However the effects of interventions on controlling overweight and obese womens GWG are inconsistent Traditional face-to-face counseling are less cost effective Effective intervention models based on Mobile health that can be scaled up are scarce Thus this randomized controlled trial aims to identify firstly whether the mobile health lifestyle interventions will be effective on improving gestational weight gain and preventing GDM among overweight or obese pregnant women secondly whether the intervention will be beneficial for improving pregnancy outcomes delivery outcomes neonatal outcomes metabolic indicators body composition indicators etc among overweight or obese pregnant women
The interventions are composed of health education online and offline health education on recommended gestational weight gain prenatal dietary guidance and physical activity recommendation diet behavior modification 8 core dietary goal setting and monitoring weekly active physical activity 150 min per week of moderate-to vigorous-intensity physical activity including aerobic exercise brisk walking and resistance exercise goal of 6000 stepsday regular face to face or telephone sessions lifestyle diet and physical activity behavior and weight monitoring via Huawei Wristband or WeChat Public Account Tailoring of the intervention will be guided by the transtheoretical model A total of 200 overweight or obese singleton pregnant women of 8-14 weeks of gestation will be recruited and they will be randomly allocated at a 11 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
Women in both study arms will attend three research appointments at 8-14 weeks baseline24-28 weeks midterm and 32-36 weeks terminal of gestation for data collection via questionnaires physical measurements and clinical laboratory examination Information on demography socioeconomic status medical and family history obstetric history current pregnancy information smoking consumption of alcohol attitude and knowledge about GWG diet and exercise habits sleep situation quality of life mental health depression anxiety social support self-efficacy etc will be collected with questionnaires and interviews by research stuff Physical measurements including weight height blood pressure and body composition using bioelectrical impedance BIA will be obtained using standardized methods Laboratory tests performed in conjunction with antenatal visits include a 75 g 2-hour oral glucose tolerance test OGTT Data on mode of delivery gestational age at birth birth weight Apgar scores perinatal complications etc will be obtained from patient records In addition blood and urine samples will be drawn at three appointments and a sample of cord blood will be collected at birth Maternal postpartum weight 42 days6 months1 year after delivery will be obtained through routine physical examination or telephone follow-up Offspring physical growth indicators such as height weight head circumference etc will be collected from routine physical examination in 42 days 6 months and 12 months of age
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None