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Electronic-personalized Program for Obesity in Pregnancy to Improve Delivery (ePPOP-ID)

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ClinicalTrials.gov Identifier: NCT02924636
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : December 2, 2017
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Pregnancy Behavioral: ePPOP-ID program Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 860 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Electronic-personalized Program for Obesity in Pregnancy to Improve Delivery - ePPOP Study
Actual Study Start Date : November 13, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intervention
personalized and online intervention. The intervention website will provide secure communication with dietician and lifestyle coaches. Women will receive emails and monthly newsletters with new content and reminder.
Behavioral: ePPOP-ID program
This is a personalized and online program. The website will provide secure communication with dietician and lifestyle coaches.
No Intervention: Control
standard care with oral information about the goal of nutritional needs during pregnancy and gestational weight gain guidelines according to BMI



Primary Outcome Measures :
  1. rate of obstetrical interventions [ Time Frame: at birth ]
    Caesarean section and instrumental delivery (forceps and vacuum extractor)


Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02924636


Contacts
Contact: Philippe Deruelle, MD,PhD +33 320446307 ext +33 philippe.deruelle@chru-lille.fr

Locations
France
CHU Lille Recruiting
Lille, France
Contact: Sylvie Deghilage    0320446467    sylvie.deghilage@chru-lille.fr   
Sponsors and Collaborators
University Hospital, Lille
Ministry of Health, France
Investigators
Principal Investigator: Philippe Deruelle, MD, PhD University Hospital, Lille

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02924636     History of Changes
Other Study ID Numbers: 2015_03
2015-A00937-42 ( Other Identifier: ID-RCB number, ANSM )
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
C-section
Instrumental delivery
Pregnancy complications
Macrosomia
Neonatal complications

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms