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

NCT01918423 | Completed

• 1 other identifier: LiPO-2
• Study Type: observational
• Target: 258
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Keywords

Childhood adiposity; Metabolic risk factors; Bone mineralization

Outcome Measures

Primary Outcomes (1)

• Child body mass standard deviation score

  On average 2.9 years of age

Secondary Outcomes (1)

• anthropometric outcomes

  On average 2.9 years of age

Other Outcomes (1)

• Anthropometric and metabolic outcomes. Bone mineralization

  On average 2.9 years of age

Study Arms (3)

Children of obese women from a RCT

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.

Behavioral: Lifestyle intervention during pregnancy

Children of obese mothers from a RCT, controls

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

Children born to normal weight women

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

Interventions

Lifestyle intervention during pregnancy BEHAVIORAL

Energy requirements for each participants´ mother were individually estimated according to weight and level of activity during pregnancy. Women in the active intervention group were encouraged to be moderately physically active 30-60 minutes a day.Women in this group also had free full time membership in a fitness center for six months. In the fitness centers they had closed training classes with trained physiotherapists for one hour each week.

Children of obese women from a RCT

Eligibility Criteria

• Age: 30 Months - 40 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Three groups of children at the ages of 2.5 til 3 years.

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Department of Endocrinology, Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (3)

• 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.

  PMID: 21972411 BACKGROUND

• 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.

  PMID: 25343235 DERIVED

• 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.

  PMID: 24586896 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

We have created a biobank of bloodsamples

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Mette Tanvig, MD

  Department of endocrinology, Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: August 7, 2013
• Study Start: February 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: August 7, 2013

Record last verified: 2013-08

Locations

DK (1)