Impact of Education During Pregnancy in Overweight Pregnant Women

Obesity Clinical Trial

— ETOIG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00804765
• Other study ID #: AOM07093
• Status: Completed
• Phase: N/A
• First received: December 8, 2008
• Last updated: August 25, 2014
• Start date: September 2008
• Est. completion date: November 2013

Study information

• Verified date: August 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: November 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Overweight
• Pediatric Obesity
• Pregnancy

Intervention

Other:
• Therapeutic education
Intensive training individual and collective teaching
• Follow-up
classical follow-up with two individual consultations

Locations

Country	Name	City	State
France	Hôpital Necker	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	-reduction of rapid infancy weight gain between 0 and 6 months		30 months	No
Secondary	-reduction of the number of children with BMI over 19 at 2 years		30 months	No
Secondary	-reduction of incidence of gestational diabetes, preeclampsia, HTA during pregnancy, caesarean, fetal macrosomia		30 months	No
Secondary	-reduction of spontaneous feeding at 4 months		30 months	No
Secondary	-increase of breastfeeding (number of women and duration)		30 months	No
Secondary	-reduction 1 and 2 years after pregnancy of mother weight and BMI (except second pregnancy)		30 months	No
Secondary	-reduction of abnormality of lipid and glycaemia test in women, 2 years after the pregnancy		30 months	No