Trial record 2 of 3283 for:    (childhood OR child) AND (female OR girl) NOT (male OR men)

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00804765
First received: December 8, 2008
Last updated: November 19, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Overweight
Obesity
Pregnancy
Childhood Obesity
Other: Therapeutic education
Other: Follow-up

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • -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 ]

Estimated Enrollment: 800
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)
Arms Assigned Interventions
Experimental: 1
Therapeutic education
Other: Therapeutic education
Intensive training individual and collective teaching
Other Name: Therapeutic education
Placebo Comparator: 2 Other: Follow-up
classical follow-up with two individual consultations
Other Name: Follow-up

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00804765

Locations
France
Hôpital Necker
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Sophie PARAT, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00804765     History of Changes
Other Study ID Numbers: AOM07093
Study First Received: December 8, 2008
Last Updated: November 19, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Prevention
child obesity
pregnancy
overweight women
obese women

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014