Lifestyle in Pregnancy and Offspring - Comparison Between Children Born to Obese Women and Children Born to Normal Weight Women (LiPO)

Odense University Hospital

Status: Completed

Conditions: Childhood Obesity

Treatments: Behavioral: Lifestyle intervention during pregnancy

Study type: Observational

Funder types: Other

Identifiers

NCT01918423

LiPO-2

Details and patient eligibility

About

Children born to obese women are at risk of increased adiposity and later adverse metabolic outcomes. We have conducted a follow-up study on an existing clinical trial, called the LiP study (Lifestyle in Pregnancy), registration number NCT00530439,in which 360 obese pregnant women were randomized to either lifestyle intervention or routine obstetric care. This present study follows the children until 3 years of age. We have the hypothesis, that the intervention during pregnancy results in a lower degree of adiposity and metabolic risk factors in the offspring. Clinical examination is taking place at age 2.5-3 years including anthropometric measurements, Dual energy x-ray (DXA) scans and blood samples measuring metabolic markers.In addition, we have included an extra control group of children born to normal weight women, who were not part of a lifestyle intervention program during pregnancy. We have the hypothesis that the children of the normal weight women have a better metabolic profile than the children born to the obese women.

Enrollment: 258 patients

Sex: All

Ages: 30 to 40 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All children born to obese women who participated in the LiP study (a randomized controlled trial of lifestyle intervention during pregnancy) and children born at term to healthy women with a normal pregestational BMI.

Exclusion criteria

• The children born to normal weight women only: preterm birth, congenital anomalies, maternal gestational diabetes, maternal diabetes mellitus, severe medical conditions in either child or mother.

Trial design

258 participants in 3 patient groups

Children of obese women from a RCT

Description:

Children born to obese women who were in the active intervention arm of the randomized controlled trial LiP. The lifestyle intervention during pregnancy consisted of two major components: dietary counseling and physical activity. Dietary counseling was performed by trained dieticians on four separate occasions at 15, 20, 28 and 35 weeks gestation.

Treatment:

Behavioral: Lifestyle intervention during pregnancy

Children of obese mothers from a RCT, controls

Description:

Children born to obese mothers who were in the control arm of the randomized controlled trial LiP.

Children born to normal weight women

Description:

Children born to women with a pregestationally normal BMI and who were not part of a lifestyle intervention programme during pregnancy.