Lifestyle in Pregnancy and Offspring

Study Overview
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Brief Summary
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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.

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

Conditions
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Childhood Obesity, Adiposity, Body Composition, Metabolic Risk Factors

Intervention / Treatment
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* Behavioral: Lifestyle intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Months
Maximum Age: 40 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle intervention<br>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<br>* 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.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index standard deviation score |  | On average 2.9 years of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat mass percent | Fat mass estimated by dxa scans. | On average 2.9 years of age |