Lifestyle in Pregnancy and Offspring - Comparison Between Children Born to Obese Women and Children Born to Normal Weight Women (LiPO)
|ClinicalTrials.gov Identifier: NCT01918423|
Recruitment Status : Completed
First Posted : August 7, 2013
Last Update Posted : August 7, 2013
|Condition or disease||Intervention/treatment|
|Childhood Obesity||Behavioral: Lifestyle intervention during pregnancy|
|Study Type :||Observational|
|Actual Enrollment :||258 participants|
|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 Start Date :||February 2011|
|Primary Completion Date :||November 2012|
|Study Completion Date :||November 2012|
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.
- Child body mass standard deviation score [ Time Frame: On average 2.9 years of age ]
- anthropometric outcomes [ Time Frame: On average 2.9 years of age ]Fat percent measured by DXA.
- Anthropometric and metabolic outcomes. Bone mineralization [ Time Frame: On average 2.9 years of age ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01918423
|Department of Endocrinology, Odense University Hospital|
|Odense, Denmark, 5000|
|Principal Investigator:||Mette Tanvig, MD||Department of endocrinology, Odense University Hospital|