Lifestyle in Pregnancy and Offspring - Comparison Between Children Born to Obese Women and Children Born to Normal Weight Women (LiPO)
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|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|
|Actual Primary Completion Date :||November 2012|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|