Lifestyle in Pregnancy and Offspring

Not Applicable

Completed

• Conditions: Body Composition; Childhood Obesity; Adiposity; Metabolic Risk Factors
• Interventions: Behavioral: Lifestyle intervention

• Registration Number: NCT01918319
• Lead Sponsor: Odense University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Study First Submitted: 2013-08-02
• Study First Submitted QC: 2013-08-05
• Study First Posted: 2013-08-07
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-30
• Last Update Posted: 2019-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle intervention	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.

Primary Outcome Measures

Name	Time	Method
Body Mass Index standard deviation score	On average 2.9 years of age

Secondary Outcome Measures

Name	Time	Method
Fat mass percent	On average 2.9 years of age	Fat mass estimated by dxa scans.

Trial Locations

Locations (1)

Department of Endocrinology, Odense University Hospital; 🇩🇰 Odense, Denmark