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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Pregnancy
• Intervention / Treatment: Behavioral: ePPOP-ID program

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
• Enrollment (Anticipated): 860
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philippe Deruelle, MD,PhD; Phone Number: +33 +33 320446307; Email: philippe.deruelle@chru-lille.fr

Study Locations

• France
  • Lille, France
    • Recruiting
    • CHU Lille
    • Contact: Sylvie Deghilage; Phone Number: 0320446467; Email: sylvie.deghilage@chru-lille.fr
    • Principal Investigator: Sandy Hanssens, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of obstetrical interventions	Caesarean section and instrumental delivery (forceps and vacuum extractor)	at birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apgar score		at birth
Total gestational weight gain		at birth
Gestational hypertension	blood pressure > 140 and/or 90 mmHg after 20 weeks	at birth
Preeclampsia	gestational hypertension and proteinuria = 0.30 g/24 h	at birth
Gestational diabetes mellitus	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	at birth
Premature birth		at birth
gestational age		at birth
Birth weight		at birth
Arterial umbilical cord pH		at birth
Neonatal traumatism	composite outcome (shoulder dystocia + fracture + brachial plexus injury)	at birth
Hyperbilirubinemia		1st week after birth
Neonatal respiratory distress syndrome		1st week after birth
Transfer in neonatal intensive care unit		1st week after birth
Maternal fever		1st week after delivery
Thromboembolic event		1st week after delivery
Hemorrhage		1st week after delivery
Breastfeeding duration		8 weeks +/- 2 weeks after delivery
Maternal weight		8 weeks +/- 2 weeks after delivery
child weight		8 weeks +/- 2 weeks after delivery

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Philippe Deruelle, MD, PhD, University Hospital, Lille

Publications and helpful links

General Publications

• Deruelle P, Lelorain S, Deghilage S, Couturier E, Guilbert E, Berveiller P, Senat MV, Vayssiere C, Sentilhes L, Perrotin F, Gallot D, Chauleur C, Sananes N, Roth E, Luton D, Caputo M, Lorio E, Chatelet C, Couster J, Timbely O, Doret-Dion M, Duhamel A, Pigeyre M. Rationale and design of ePPOP-ID: a multicenter randomized controlled trial using an electronic-personalized program for obesity in pregnancy to improve delivery. BMC Pregnancy Childbirth. 2020 Oct 7;20(1):602. doi: 10.1186/s12884-020-03288-x.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2017
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: October 4, 2016
• First Submitted That Met QC Criteria: October 4, 2016
• First Posted (Estimate): October 5, 2016

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: C-section; Pregnancy complications; Macrosomia; Instrumental delivery; Neonatal complications
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Pregnancy Complications; Obesity; Obesity, Maternal
• Other Study ID Numbers: 2015_03; 2015-A00937-42 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No