Impact of Education During Pregnancy in Overweight Pregnant Women (ETOIG)
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.
Other: Therapeutic education
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||Impact of Pregnant Women Education in Case of Overweight or Obesity on Risk of Child Overweight and Pregnancy Outcome|
- 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 ]
- -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 ]
|Study Start Date:||September 2008|
|Estimated Study Completion Date:||November 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Other: Therapeutic education
Intensive training individual and collective teaching
Other Name: Therapeutic education
|Placebo Comparator: 2||
classical follow-up with two individual consultations
Other Name: Follow-up
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00804765
|Paris, France, 75015|
|Principal Investigator:||Sophie PARAT, MD||Assistance Publique - Hôpitaux de Paris|