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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Therapeutic education |
|
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic education | Other | Intensive training individual and collective teaching |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 Months |
| Measure | Description | Time Frame |
|---|---|---|
| -reduction of rapid infancy weight gain between 0 and 6 months | 30 months | |
| -reduction of the number of children with BMI over 19 at 2 years | 30 months | |
| -reduction of incidence of gestational diabetes, preeclampsia, HTA during pregnancy, caesarean, fetal macrosomia |
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Inclusion criteria :
Exclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Sophie PARAT, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Necker | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30242235 | Result | 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. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Follow-up |
| Other |
classical follow-up with two individual consultations |
|
| 30 months |
| -reduction of spontaneous feeding at 4 months | 30 months |
| -increase of breastfeeding (number of women and duration) | 30 months |
| -reduction 1 and 2 years after pregnancy of mother weight and BMI (except second pregnancy) | 30 months |
| -reduction of abnormality of lipid and glycaemia test in women, 2 years after the pregnancy | 30 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |