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Completed

NCT Number: NCT01918423

Lifestyle in Pregnancy and Offspring - Comparison Between Children Born to Obese Women and Children Born to Normal Weight Women

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.In addition, we have included an extra control group of children born to normal weight women, who were not part of a lifestyle intervention program during pregnancy. We have the hypothesis that the children of the normal weight women have a better metabolic profile than the children born to the obese women.

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Key information

Conditions

Childhood Obesity Body Weight 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

Observational

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

  • All children born to obese women who participated in the LiP study (a randomized controlled trial of lifestyle intervention during pregnancy) and children born at term to healthy women with a normal pregestational BMI.

Exclusion criteria

  • The children born to normal weight women only: preterm birth, congenital anomalies, maternal gestational diabetes, maternal diabetes mellitus, severe medical conditions in either child or mother.

Treatment and study plan

Lifestyle intervention during pregnancy

Behavioral

Energy requirements for each participants´ mother 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. Child body mass standard deviation score

    Time frame: On average 2.9 years of age

Secondary outcomes

  1. anthropometric outcomes

    Time frame: On average 2.9 years of age

    Fat percent measured by DXA.

Other outcomes

  1. Anthropometric and metabolic outcomes. 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 estimated with dual energy x-ray and a computer program estimating bone health index (BHI) from x-rays of the hand.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

The Effects of Lifestyle Intervention During Pregnancy in Obese Women on Offspring Adiposity and Metabolic Risk Factors- Comparison With Offspring of Normal Weight Women Not Participating in a Lifestyle Intervention Programme.

Acronym: LiPO

Important dates

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

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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