NCT02924636

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
857

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 13, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2022

Completed
Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

4.3 years

First QC Date

October 4, 2016

Last Update Submit

December 4, 2025

Conditions

PregnancyObesity

Keywords

C-sectionInstrumental deliveryPregnancy complicationsMacrosomiaNeonatal complications

Outcome Measures

Primary Outcomes (1)

  • rate of obstetrical interventions

    Caesarean section and instrumental delivery (forceps and vacuum extractor)

    at birth

Secondary Outcomes (19)

  • Total gestational weight gain

    at birth

  • Gestational hypertension

    at birth

  • Preeclampsia

    at birth

  • Gestational diabetes mellitus

    at birth

  • Premature birth

    at birth

  • +14 more secondary outcomes

Study Arms (2)

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.

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

Interventions

ePPOP-ID programBEHAVIORAL

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

Intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Lille

Lille, France

Location

Related Publications (1)

  • 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.

    PMID: 33028261RESULT

MeSH Terms

Conditions

ObesityPregnancy Complications

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Philippe Deruelle, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2016

First Posted

October 5, 2016

Study Start

November 13, 2017

Primary Completion

March 13, 2022

Study Completion

April 13, 2022

Last Updated

December 11, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)