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Completed

NCT Number: NCT00804765

Impact of Education During Pregnancy in Overweight Pregnant Women

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Necker

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Therapeutic education

Other

Intensive training individual and collective teaching

Follow-up

Other

classical follow-up with two individual consultations

Primary outcomes

  1. 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 outcomes

  1. -reduction of rapid infancy weight gain between 0 and 6 months

    Time frame: 30 months

  2. -reduction of the number of children with BMI over 19 at 2 years

    Time frame: 30 months

  3. -reduction of incidence of gestational diabetes, preeclampsia, HTA during pregnancy, caesarean, fetal macrosomia

    Time frame: 30 months

  4. -reduction of spontaneous feeding at 4 months

    Time frame: 30 months

  5. -increase of breastfeeding (number of women and duration)

    Time frame: 30 months

  6. -reduction 1 and 2 years after pregnancy of mother weight and BMI (except second pregnancy)

    Time frame: 30 months

  7. -reduction of abnormality of lipid and glycaemia test in women, 2 years after the pregnancy

    Time frame: 30 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Impact of Pregnant Women Education in Case of Overweight or Obesity on Risk of Child Overweight and Pregnancy Outcome

Acronym: ETOIG

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Dec 9, 2008
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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