Clinical trial NCT01918319: Lifestyle in Pregnancy and Offspring
Official title: The Effect of Lifestyle Intervention in Pregnancy - Follow-up on the Offspring in Early Childhood.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Adiposity
Body Composition
Metabolic Risk Factors
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2013-08-07
Enrollment: 157
Sex: ALL
Minimum age (years): 30
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* children born to women who were part of the preceding LiP study and who completed the LiP study until birth. Inclusion criteria for the LiP study:
* singleton pregnant
* BMI \>/= 30 and \</= 45 E xclusion Criteria for preceding LiP study:
* Chronic diseases
* Not Danish speaking
* Abuse of alcohol or drugs
* Preterm delivery in earlier pregnancies

Primary outcomes:
measure: Body Mass Index standard deviation score
timeFrame: On average 2.9 years of age
Secondary outcomes:
measure: Fat mass percent
timeFrame: On average 2.9 years of age
Other outcomes:
measure: Anthropometric and metabolic risk factors and 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.