Lifestyle in Pregnancy and Offspring

Childhood Obesity Clinical Trial

— LiPO  

Official title:

The Effect of Lifestyle Intervention in Pregnancy - Follow-up on the Offspring in Early Childhood.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01918319
• Other study ID #: LiPO
• Status: Completed
• Phase: N/A
• Start date: February 2011
• Est. completion date: November 2012

Study information

• Verified date: August 2019
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Months to 40 Months

Eligibility

Inclusion Criteria:

• children born to women who were part of the preceding LiP study and who completed the LiP study until birth. Inclusion criteria for the LiP study:

• singleton pregnant

• BMI >/= 30 and </= 45 E xclusion Criteria for preceding LiP study:

• Chronic diseases

• Not Danish speaking

• Abuse of alcohol or drugs

• Preterm delivery in earlier pregnancies

Related Conditions & MeSH terms

• Adiposity
• Body Composition
• Childhood Obesity
• Metabolic Risk Factors
• Pediatric Obesity

Intervention

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.

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 risk factors and 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 measured by dual energy x-ray	On average 2.9 years of age
Primary	Body Mass Index standard deviation score		On average 2.9 years of age
Secondary	Fat mass percent	Fat mass estimated by dxa scans.	On average 2.9 years of age