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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00804765
First received: December 8, 2008
Last updated: August 25, 2014
Last verified: August 2014

December 8, 2008
August 25, 2014
September 2008
April 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00804765 on ClinicalTrials.gov Archive Site
  • -reduction of rapid infancy weight gain between 0 and 6 months [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • -reduction of the number of children with BMI over 19 at 2 years [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • -reduction of incidence of gestational diabetes, preeclampsia, HTA during pregnancy, caesarean, fetal macrosomia [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • -reduction of spontaneous feeding at 4 months [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • -increase of breastfeeding (number of women and duration) [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • -reduction 1 and 2 years after pregnancy of mother weight and BMI (except second pregnancy) [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • -reduction of abnormality of lipid and glycaemia test in women, 2 years after the pregnancy [ Time Frame: 30 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Impact of Education During Pregnancy in Overweight Pregnant Women
Impact of Pregnant Women Education in Case of Overweight or Obesity on Risk of Child Overweight and Pregnancy Outcome

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Overweight
  • Obesity
  • Pregnancy
  • Childhood Obesity
  • Other: Therapeutic education
    Intensive training individual and collective teaching
    Other Name: Therapeutic education
  • Other: Follow-up
    classical follow-up with two individual consultations
    Other Name: Follow-up
  • Experimental: 1
    Therapeutic education
    Intervention: Other: Therapeutic education
  • Placebo Comparator: 2
    Intervention: Other: Follow-up
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
275
November 2013
April 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00804765
AOM07093
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Sophie PARAT, MD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP