- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00804765
Impact of Education During Pregnancy in Overweight Pregnant Women (ETOIG)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75015
- Hopital Necker
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: 2
|
classical follow-up with two individual consultations
|
|
Experimental: 1
Therapeutic education
|
Intensive training individual and collective teaching
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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.
Time Frame: 30 Months
|
30 Months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
-reduction of rapid infancy weight gain between 0 and 6 months
Time Frame: 30 months
|
30 months
|
|
-reduction of the number of children with BMI over 19 at 2 years
Time Frame: 30 months
|
30 months
|
|
-reduction of incidence of gestational diabetes, preeclampsia, HTA during pregnancy, caesarean, fetal macrosomia
Time Frame: 30 months
|
30 months
|
|
-reduction of spontaneous feeding at 4 months
Time Frame: 30 months
|
30 months
|
|
-increase of breastfeeding (number of women and duration)
Time Frame: 30 months
|
30 months
|
|
-reduction 1 and 2 years after pregnancy of mother weight and BMI (except second pregnancy)
Time Frame: 30 months
|
30 months
|
|
-reduction of abnormality of lipid and glycaemia test in women, 2 years after the pregnancy
Time Frame: 30 months
|
30 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sophie PARAT, MD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AOM07093
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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