CHU Lille
Lille, France
NCT Number: NCT02924636
The purpose of this study is to assess the efficacy of an electronic-based intervention to help pregnant overweight and obese women gain an appropriate amount of weight and improve their delivery i.e. to reduce the rate of labour procedures and interventions. We chose a composite outcome including instrumental delivery and Caesarean section, as clinically relevant outcomes because the mode of delivery is one of the major goals of the obstetrical management and is is strongly associated with body mass index and gestational weight gain.
Looking for future studies?
Notify Me18 year–45 year
Female
Interventional
Not applicable
Lille, France
Our study is an open, multicenter, randomized, parallel-group, controlled trial. This study will include obese pregnant women recruited in 11 French university hospitals. Patients will be randomized into two-parallel groups. One group underwent the electronic-personalized program (the interventional group) and the other underwent standard care (the control group). Due to the intervention by itself, a blind study would not be achievable.
Intervention group (the electronic-personalized program) The intervention will be presented as a comprehensive dietary and lifestyle intervention called "e-PPOP-ID" (electronic Personalized Programmed for Obesity in Pregnancy to Improve Delivery), including a combination of dietary, exercise, and behavioral strategies delivered on a web site.
The intervention will start at the latest by 20 weeks of pregnancy throughout the pregnancy and 8 weeks post-partum.
Pregnant women of the intervention group will be given an access to a personalized patient centric e-health platform. The platform we be specifically designed for this program. Various modules of this platform will be activated:
Dieticians and adapted physical education teachers will develop the content.These lessons will include nutritional needs, motivational and behavioral advices, recipes, and movies of exercises easily achievable. The objective e-learning program is to limit weight gain by encouraging to healthy balance of carbohydrates, fat, protein, reducing high-energy foods intake (refined carbohydrates and saturated fats), increasing intake of fruits and vegetables and also by encouraging to physical activity. A second evaluation at around the 30th gestational weeks will allow adapting the lessons of the e-learning program, according to the progress of patients.
A Social network:
The platform will propose various social networking tools that can link the patient together or link the patient with the care team. Using a pseudo, patient will be able to connect together and interact with various tools such as a secured instant message system, a secured videoconference and a forum.
Motivation concepts Pregnant women will receive emails, which will encourage them to log in website and follow an e-learning lessons.A newsletter will be sent every month and will link to the new contents of the web site.Adhesion of program will be measured monthly by self-questionnaire of satisfaction and by measuring the time spent on the website including the forum.
Control group (Standard care):
The control group will receive standard care with oral information about the goal of nutritional needs during pregnancy and gestational weight gain guidelines according to BMI.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This is a personalized and online program. The website will provide secure communication with dietician and lifestyle coaches.
Time frame: at birth
Caesarean section and instrumental delivery (forceps and vacuum extractor)
Time frame: at birth
Time frame: at birth
blood pressure > 140 and/or 90 mmHg after 20 weeks
Time frame: at birth
gestational hypertension and proteinuria = 0.30 g/24 h
Time frame: at birth
Diagnosed by a 75g-oral glucose tolerance test (OGTT) between 24 and 28 according to French guidelines and International Association diabetic and Pregnancy Study Group
Time frame: at birth
Time frame: at birth
Time frame: at birth
Time frame: at birth
Time frame: at birth
Time frame: at birth
composite outcome (shoulder dystocia + fracture + brachial plexus injury)
Time frame: 1st week after birth
Time frame: 1st week after birth
Time frame: 1st week after birth
Time frame: 1st week after delivery
Time frame: 1st week after delivery
Time frame: 1st week after delivery
Time frame: 8 weeks +/- 2 weeks after delivery
Time frame: 8 weeks +/- 2 weeks after delivery
Time frame: 8 weeks +/- 2 weeks after delivery
University Hospital, Lille
Other
Electronic-personalized Program for Obesity in Pregnancy to Improve Delivery - ePPOP Study
Acronym: ePPOP-ID
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03509805
Apnea, Apnea, Obstructive Sleep
Lille, North, France
View Trial DetailsNCT02701426
Behavior, Body Weight
Lille, France
View Trial DetailsNCT00804765
Body Weight, Childhood Obesity
Paris, France
View Trial DetailsNCT02791568
Body Weight, Female Urogenital Diseases and Pregnancy Complications
Madison, Wisconsin, United States
View Trial Details