Clinical trial NCT01918423: Lifestyle in Pregnancy and Offspring - Comparison Between Children Born to Obese Women and Children Born to Normal Weight Women
Official title: The Effects of Lifestyle Intervention During Pregnancy in Obese Women on Offspring Adiposity and Metabolic Risk Factors- Comparison With Offspring of Normal Weight Women Not Participating in a Lifestyle Intervention Programme.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Obesity
Keywords: Childhood adiposity
Metabolic risk factors
Bone mineralization
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2013-08-07
Enrollment: 258
Sex: ALL
Minimum age (years): 30
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Three groups of children at the ages of 2.5 til 3 years.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Child body mass standard deviation score
timeFrame: On average 2.9 years of age
Secondary outcomes:
measure: anthropometric outcomes
timeFrame: On average 2.9 years of age
Other outcomes:
measure: Anthropometric and metabolic outcomes. Bone mineralization
timeFrame: On average 2.9 years of age
Locations:
city: Odense
country: Denmark
facility: Department of Endocrinology, Odense University Hospital
Study officials:
affiliation: Department of endocrinology, Odense University Hospital
name: Mette Tanvig, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vinter CA, Jensen DM, Ovesen P, Beck-Nielsen H, Jorgensen JS. The LiP (Lifestyle in Pregnancy) study: a randomized controlled trial of lifestyle intervention in 360 obese pregnant women. Diabetes Care. 2011 Dec;34(12):2502-7. doi: 10.2337/dc11-1150. Epub 2011 Oct 4.
citation: Tanvig M, Vinter CA, Jorgensen JS, Wehberg S, Ovesen PG, Beck-Nielsen H, Christesen HT, Jensen DM. Effects of lifestyle intervention in pregnancy and anthropometrics at birth on offspring metabolic profile at 2.8 years: results from the Lifestyle in Pregnancy and Offspring (LiPO) study. J Clin Endocrinol Metab. 2015 Jan;100(1):175-83. doi: 10.1210/jc.2014-2675.
citation: Tanvig M, Vinter CA, Jorgensen JS, Wehberg S, Ovesen PG, Lamont RF, Beck-Nielsen H, Christesen HT, Jensen DM. Anthropometrics and body composition by dual energy X-ray in children of obese women: a follow-up of a randomized controlled trial (the Lifestyle in Pregnancy and Offspring [LiPO] study). PLoS One. 2014 Feb 24;9(2):e89590. doi: 10.1371/journal.pone.0089590. eCollection 2014.