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Completed

NCT Number: NCT02924636

Electronic-personalized Program for Obesity in Pregnancy to Improve Delivery

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.

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Key information

About this study

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:

  • An e-learning program: An e-Learning module will propose personalized content to each patient. Before the program, patients have to fill in questionnaires about food consumption (FFQ), Eating behavior (TFEQ) and physical activity (IPAQ). The answers of these questionnaires will be taken into account to define the e-learning lessons that patients must follow.Multi educational supports such as videos, fact sheets, quiz will be integrated into this program. Patient will be motivated to validate their program thanks to a reward system (access to new content by earning stars) and their knowledge can be estimated thanks to a quiz system.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Obese pregnant women (30 ≤ BMI < 40 kg/m2)
  • Singleton pregnancy between 12+0 to 19+6 weeks of pregnancy
  • Having an email address and an Internet access

Exclusion criteria

  • BMI < 30 kg/m2 or BMI > 40 kg/m2
  • History of more than 2 miscarriages
  • Severe heart disease (arrhythmias, history of myocardial infarction)
  • Multiple pregnancy
  • Unstable thyroid disease
  • Uncontrolled hypertension
  • Pre-gestational diabetes
  • Bariatric surgery
  • Any medical condition that may interfere with physical activity during pregnancy
  • No access to Internet
  • Minor
  • Absence of health insurance
  • Guardianship
  • Refusal to participate in research

Treatment and study plan

ePPOP-ID program

Behavioral

This is a personalized and online program. The website will provide secure communication with dietician and lifestyle coaches.

Primary outcomes

  1. rate of obstetrical interventions

    Time frame: at birth

    Caesarean section and instrumental delivery (forceps and vacuum extractor)

Secondary outcomes

  1. Total gestational weight gain

    Time frame: at birth

  2. Gestational hypertension

    Time frame: at birth

    blood pressure > 140 and/or 90 mmHg after 20 weeks

  3. Preeclampsia

    Time frame: at birth

    gestational hypertension and proteinuria = 0.30 g/24 h

  4. Gestational diabetes mellitus

    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

  5. Premature birth

    Time frame: at birth

  6. gestational age

    Time frame: at birth

  7. Birth weight

    Time frame: at birth

  8. Apgar score

    Time frame: at birth

  9. Arterial umbilical cord pH

    Time frame: at birth

  10. Neonatal traumatism

    Time frame: at birth

    composite outcome (shoulder dystocia + fracture + brachial plexus injury)

  11. Hyperbilirubinemia

    Time frame: 1st week after birth

  12. Neonatal respiratory distress syndrome

    Time frame: 1st week after birth

  13. Transfer in neonatal intensive care unit

    Time frame: 1st week after birth

  14. Maternal fever

    Time frame: 1st week after delivery

  15. Thromboembolic event

    Time frame: 1st week after delivery

  16. Hemorrhage

    Time frame: 1st week after delivery

  17. Breastfeeding duration

    Time frame: 8 weeks +/- 2 weeks after delivery

  18. Maternal weight

    Time frame: 8 weeks +/- 2 weeks after delivery

  19. child weight

    Time frame: 8 weeks +/- 2 weeks after delivery

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

Electronic-personalized Program for Obesity in Pregnancy to Improve Delivery - ePPOP Study

Acronym: ePPOP-ID

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Oct 5, 2016
Registry last updated
Dec 11, 2025

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.

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