Lifestyle in Pregnancy and Offspring - Comparison Between Children Born to Obese Women and Children Born to Normal Weight Women (LiPO)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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.|
- Child body mass standard deviation score [ Time Frame: On average 2.9 years of age ] [ Designated as safety issue: No ]
- anthropometric outcomes [ Time Frame: On average 2.9 years of age ] [ Designated as safety issue: No ]Fat percent measured by DXA.
- Anthropometric and metabolic outcomes. Bone mineralization [ Time Frame: On average 2.9 years of age ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples Without DNA
We have created a biobank of bloodsamples
|Study Start Date:||February 2011|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
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
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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01918423
|Department of Endocrinology, Odense University Hospital|
|Odense, Denmark, 5000|
|Principal Investigator:||Mette Tanvig, MD||Department of endocrinology, Odense University Hospital|