ObesityePPOP-IDNCT02924636
Electronic-personalized Program for Obesity in Pregnancy to Improve Delivery
A study testing ePPOP-ID program in people with Obesity and Pregnancy, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- What is being tested?
- ePPOP-ID program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 857 participants
- Where
- 1 siteFrance
- Study dates
- 13 Nov 2017to 13 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- ePPOP-ID program
- Keywords
- C-section, Instrumental delivery, Pregnancy complications, Macrosomia, Neonatal complications
- Medical subject headings
- Obesity, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePPOP-ID programBehavioural
This is a personalized and online program. The website will provide secure communication with dietician and lifestyle coaches.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: ePPOP-ID program |
| Control | No intervention | standard care with oral information about the goal of nutritional needs during pregnancy and gestational weight gain guidelines according to BMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of obstetrical interventions
Caesarean section and instrumental delivery (forceps and vacuum extractor)
Measured: at birth
Secondary outcomes (19)
Total gestational weight gain
Measured: at birth
Gestational hypertension
blood pressure > 140 and/or 90 mmHg after 20 weeks
Measured: at birth
Preeclampsia
gestational hypertension and proteinuria = 0.30 g/24 h
Measured: 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
Measured: at birth
Premature birth
Measured: at birth
gestational age
Measured: at birth
Birth weight
Measured: at birth
Apgar score
Measured: at birth
Arterial umbilical cord pH
Measured: at birth
Neonatal traumatism
composite outcome (shoulder dystocia + fracture + brachial plexus injury)
Measured: at birth
Hyperbilirubinemia
Measured: 1st week after birth
Neonatal respiratory distress syndrome
Measured: 1st week after birth
Transfer in neonatal intensive care unit
Measured: 1st week after birth
Maternal fever
Measured: 1st week after delivery
Thromboembolic event
Measured: 1st week after delivery
Hemorrhage
Measured: 1st week after delivery
Breastfeeding duration
Measured: 8 weeks +/- 2 weeks after delivery
Maternal weight
Measured: 8 weeks +/- 2 weeks after delivery
child weight
Measured: 8 weeks +/- 2 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start13 Nov 2017
- Primary completion13 Mar 2022
- Study completion13 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 857 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Philippe Deruelle, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924636
- Sponsor's protocol ID
- 2015_03
- Other IDs
- 2015-A00937-42
- Acronym
- ePPOP-ID
- Status last verified
- Dec 2025
- First submitted
- 4 Oct 2016
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33028261
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic-personalized Program for Obesity in Pregnancy to Improve Delivery - ePPOP Study
- ClinicalTrials.gov ID
- NCT02924636
- Acronym / sponsor ID
- ePPOP-ID / 2015_03
- Keywords
- C-section, Instrumental delivery, Pregnancy complications, Macrosomia, Neonatal complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 857 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 13 Mar 2022 (actual)
- Study completion
- 13 Apr 2022 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: ePPOP-ID programpersonalized 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. |
| Control | No intervention | –standard care with oral information about the goal of nutritional needs during pregnancy and gestational weight gain guidelines according to BMI |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ePPOP-ID programThis is a personalized and online program. The website will provide secure communication with dietician and lifestyle coaches. | Behavioural | Intervention |
Primary outcome
rate of obstetrical interventions
Time frame: at birth
Caesarean section and instrumental delivery (forceps and vacuum extractor)
19 secondary outcomes
Total gestational weight gain
Time frame: at birth
Gestational hypertension
Time frame: at birth
Preeclampsia
Time frame: at birth
Gestational diabetes mellitus
Time frame: at birth
Premature birth
Time frame: at birth
gestational age
Time frame: at birth
Birth weight
Time frame: at birth
Apgar score
Time frame: at birth
Arterial umbilical cord pH
Time frame: at birth
Neonatal traumatism
Time frame: at birth
Hyperbilirubinemia
Time frame: 1st week after birth
Neonatal respiratory distress syndrome
Time frame: 1st week after birth
Transfer in neonatal intensive care unit
Time frame: 1st week after birth
Maternal fever
Time frame: 1st week after delivery
Thromboembolic event
Time frame: 1st week after delivery
Hemorrhage
Time frame: 1st week after delivery
Breastfeeding duration
Time frame: 8 weeks +/- 2 weeks after delivery
Maternal weight
Time frame: 8 weeks +/- 2 weeks after delivery
child weight
Time frame: 8 weeks +/- 2 weeks after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Results publication: PubMed 33028261Deruelle 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.
- Individual participant dataSharing planned: No
Related trials for Obesity
Active, not recruitingPhase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
Electric Stimulation Therapy, Obesity
Not yet recruiting
High-Flow Nasal Oxygen-Assisted Deep Extubation Versus Awake Extubation in Morbidly Obese Patients
Deep Tracheal Extubation
Active, not recruiting
Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function
Obesity, Weight Loss
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Deruelle, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ePPOP-ID program in people with Obesity and Pregnancy, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of obstetrical interventions (time frame: at birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02924636, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.