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OpenTrials
Completed

NCT Number: NCT01918319

Lifestyle in Pregnancy and Offspring

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.

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Key information

Conditions

Childhood Obesity Adiposity Body Composition Body Weight Metabolic Risk Factors Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

30 month–40 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Endocrinology, Odense University Hospital

Odense, 5000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Intervention

Behavioral

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.

Primary outcomes

  1. Body Mass Index standard deviation score

    Time frame: On average 2.9 years of age

Secondary outcomes

  1. Fat mass percent

    Time frame: On average 2.9 years of age

    Fat mass estimated by dxa scans.

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

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

Acronym: LiPO

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 7, 2013
Registry last updated
Sep 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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