Impact of Education During Pregnancy in Overweight Pregnant Women

NCT00804765 | Completed

• 1 other identifier: AOM07093
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight; Obesity; Pregnancy; Childhood Obesity

Keywords

Prevention; child obesity; pregnancy; overweight women; obese women

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• -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

  30 months

• -reduction of spontaneous feeding at 4 months

  30 months

• -increase of breastfeeding (number of women and duration)

  30 months

Study Arms (2)

1

EXPERIMENTAL

Therapeutic education

Other: Therapeutic education

2

PLACEBO COMPARATOR

Other: Follow-up

Interventions

Therapeutic education OTHER

Intensive training individual and collective teaching

1

Follow-up OTHER

classical follow-up with two individual consultations

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• women younger than 18 yrs,
• multiple gestation,
• high risk pregnancy,
• psychiatric pathology,
• fetal malformation
• history of obesity surgery
• Women with no understanding of French language
• Women planning to move to another area.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker

Paris, 75015, France

Location

Related Publications (1)

• 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.

  PMID: 30242235 RESULT

MeSH Terms

Conditions

Overweight; Obesity; Pediatric Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sophie PARAT, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 9, 2008
• Study Start: September 1, 2008
• Primary Completion: April 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 20, 2025

Record last verified: 2025-09

Locations

FR (1)