Lifestyle in Pregnancy and Offspring (LiPO)
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|ClinicalTrials.gov Identifier: NCT01918319|
Recruitment Status : Completed
First Posted : August 7, 2013
Last Update Posted : August 7, 2013
|Condition or disease||Intervention/treatment||Phase|
|Offspring BMI Standard Deviation Score. Childhood Obesity Adiposity Body Composition Metabolic Risk Factors||Behavioral: Lifestyle intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||157 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effect of Lifestyle Intervention in Pregnancy - Follow-up on the Offspring in Early Childhood.|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Experimental: Lifestyle intervention
The active intervention 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
Energy requirements for each participant 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.
|No Intervention: Control|
- Body Mass Index standard deviation score [ Time Frame: On average 2.9 years of age ]
- Fat mass percent [ Time Frame: On average 2.9 years of age ]Fat mass estimated by dxa scans.
- Anthropometric and metabolic risk factors and 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 measured by dual energy x-ray
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): NCT01918319
|Department of Endocrinology, Odense University Hospital|
|Odense, Denmark, 5000|
|Principal Investigator:||Mette Tanvig, MD||Department of endocrinology, Odense University Hospital|