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

Childhood Obesity Clinical Trial

— LiPO  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01918423
• Other study ID #: LiPO-2
• Status: Completed
• Phase: N/A
• First received: August 2, 2013
• Last updated: August 5, 2013
• Start date: February 2011
• Est. completion date: November 2012

Study information

• Verified date: August 2013
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Months to 40 Months

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Lifestyle intervention during pregnancy
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.

Locations

Country	Name	City	State
Denmark	Department of Endocrinology, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Vinter CA, Jensen DM, Ovesen P, Beck-Nielsen H, Jørgensen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anthropometric and metabolic outcomes. Bone mineralization	BMI, Skinfold thicknesses, abdominal circumference, hip circumference, abdominal to hip circumference ratio, height, weight. DXA scan: fat mass, fat mass percent, lean mass, lean mass percent, body fat distribution. Bone mass density, bone mass content. Fasting blood glucose, HbA1C, fasting insulin, fasting c-peptide, fasting lipids; HDL; LDL, triglycerides, total cholesterol. 25-hydroxy vitamin D. Bone mineralization estimated with dual energy x-ray and a computer program estimating bone health index (BHI) from x-rays of the hand.	On average 2.9 years of age	No
Primary	Child body mass standard deviation score		On average 2.9 years of age	No
Secondary	anthropometric outcomes	Fat percent measured by DXA.	On average 2.9 years of age	No