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Impact of Education During Pregnancy in Overweight Pregnant Women (ETOIG)

Primary Purpose

Overweight, Obesity, Pregnancy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Therapeutic education
Follow-up
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Prevention, child obesity, pregnancy, overweight women, obese women

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria :

  • Pregnant women who agree the study
  • BMI > 25 kg/m². BMI is based on retrospective self reported weight of the patient before pregnancy.
  • No more that 21 weeks of gestation.
  • Social security

Exclusion criteria :

  • women younger than 18 yrs,
  • multiple gestation,
  • high risk pregnancy,
  • psychiatric pathology,
  • diabetes diagnosed before the inclusion
  • fetal malformation
  • history of obesity surgery
  • Women with no understanding of French language
  • Women planning to move to another area.

Sites / Locations

  • Hôpital Necker

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Therapeutic education

Outcomes

Primary Outcome Measures

30 per cent reduction of rapid infancy weight gain at two years defined as > +0,67 change in weight SD score. The 0,67 SD represents the difference between the displayed centile lines on standard infant growth charts.

Secondary Outcome Measures

-reduction of rapid infancy weight gain between 0 and 6 months
-reduction of the number of children with BMI over 19 at 2 years
-reduction of incidence of gestational diabetes, preeclampsia, HTA during pregnancy, caesarean, fetal macrosomia
-reduction of spontaneous feeding at 4 months
-increase of breastfeeding (number of women and duration)
-reduction 1 and 2 years after pregnancy of mother weight and BMI (except second pregnancy)
-reduction of abnormality of lipid and glycaemia test in women, 2 years after the pregnancy

Full Information

First Posted
December 8, 2008
Last Updated
August 25, 2014
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00804765
Brief Title
Impact of Education During Pregnancy in Overweight Pregnant Women
Acronym
ETOIG
Official Title
Impact of Pregnant Women Education in Case of Overweight or Obesity on Risk of Child Overweight and Pregnancy Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Metabolic environment of the foetus during pregnancy in obese women is altered and the child exposed at an increased risk of obesity. Rapid infancy and childhood weight gain is associated with subsequent obesity. The purpose of the study is to test the efficacy of an educational intervention during pregnancy in obese or overweight women, on the reduction of rapid infancy weight gain in the two first years of life.
Detailed Description
In a first time, we propose to pregnant overweight women to participate a study based on the follow up of their pregnancy and of their child during the two first years of life. Women in agreement with the study sign a consent form and fill in a questionnaire about their quality of live. We secondly randomized the women in two groups: Group A: in this group an intervention is delivered. It provide education, at regularly scheduled sessions (20 weeks, 28 weeks, 35 weeks, and 2 month after delivering) and two dietary consulting. The sessions that stress about healthy eating and modest exercise assemble several women (no more than 10). Women in agreement with this intervention sign a consent form. Group B: in this group, pregnant women are managed with standard care (at least one dietary consulting is proposed around 26 weeks). Risk factors for child obesity are researched by questionnaire (parents smoking habit, mother and father level of education, family history of obesity, risk factors for gestational diabetes…). Mother weight measured at every clinic visit, is recorded as complications during pregnancy (HTA, preeclampsia, diabetes, fetal malformation …) and during delivery. Mother glycosylated haemoglobin is measured at birth. Variables of interest for the children included at birth: gestational age, sex, neonatal pathology, hospitalisations and hypoglycaemia episode. Measurement, and method of infant feeding are recorded at birth, and by phone call every 2 months during 6 months, at 9 month, 1 year, 18 months and 2 years. At 4 months the mother fill in a questionnaire about the amount of milk or other foods eaten by the child. A visit is planed at 2 years for: clinical examination of the child, recording of his nutritional and exercise habits questionnaire about quality of life of the mother and her health measurement of her BMI, arterial pressure, glycaemia before and after 75 g oral glucose-tolerance test, glycosylated hemoglobin, and lipid test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Pregnancy, Childhood Obesity
Keywords
Prevention, child obesity, pregnancy, overweight women, obese women

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
275 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Therapeutic education
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Therapeutic education
Intervention Description
Intensive training individual and collective teaching
Intervention Type
Other
Intervention Name(s)
Follow-up
Intervention Description
classical follow-up with two individual consultations
Primary Outcome Measure Information:
Title
30 per cent reduction of rapid infancy weight gain at two years defined as > +0,67 change in weight SD score. The 0,67 SD represents the difference between the displayed centile lines on standard infant growth charts.
Time Frame
30 Months
Secondary Outcome Measure Information:
Title
-reduction of rapid infancy weight gain between 0 and 6 months
Time Frame
30 months
Title
-reduction of the number of children with BMI over 19 at 2 years
Time Frame
30 months
Title
-reduction of incidence of gestational diabetes, preeclampsia, HTA during pregnancy, caesarean, fetal macrosomia
Time Frame
30 months
Title
-reduction of spontaneous feeding at 4 months
Time Frame
30 months
Title
-increase of breastfeeding (number of women and duration)
Time Frame
30 months
Title
-reduction 1 and 2 years after pregnancy of mother weight and BMI (except second pregnancy)
Time Frame
30 months
Title
-reduction of abnormality of lipid and glycaemia test in women, 2 years after the pregnancy
Time Frame
30 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria : Pregnant women who agree the study BMI > 25 kg/m². BMI is based on retrospective self reported weight of the patient before pregnancy. No more that 21 weeks of gestation. Social security Exclusion criteria : women younger than 18 yrs, multiple gestation, high risk pregnancy, psychiatric pathology, diabetes diagnosed before the inclusion fetal malformation history of obesity surgery Women with no understanding of French language Women planning to move to another area.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie PARAT, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Necker
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
30242235
Citation
Parat S, Negre V, Baptiste A, Valensi P, Bertrand AM, Chollet C, Dabbas M, Altman JJ, Lapillonne A, Treluyer JM, Elie C, Tauber M, Lorenzini F, Cosson E. Prenatal education of overweight or obese pregnant women to prevent childhood overweight (the ETOIG study): an open-label, randomized controlled trial. Int J Obes (Lond). 2019 Feb;43(2):362-373. doi: 10.1038/s41366-018-0205-z. Epub 2018 Sep 21.
Results Reference
derived

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Impact of Education During Pregnancy in Overweight Pregnant Women

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