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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mette Tanvig, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01918423
First received: August 2, 2013
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Childhood Obesity
Behavioral: Lifestyle intervention during pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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.

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Child body mass standard deviation score [ Time Frame: On average 2.9 years of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • anthropometric outcomes [ Time Frame: On average 2.9 years of age ] [ Designated as safety issue: No ]
    Fat percent measured by DXA.


Other Outcome Measures:
  • Anthropometric and metabolic outcomes. Bone mineralization [ Time Frame: On average 2.9 years of age ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

We have created a biobank of bloodsamples


Enrollment: 258
Study Start Date: February 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Children of obese women from a RCT
Children born to obese women who were in the active intervention arm of the randomized controlled trial LiP. The lifestyle intervention during pregnancy 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 during pregnancy
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.
Children of obese mothers from a RCT, controls
Children born to obese mothers who were in the control arm of the randomized controlled trial LiP.
Children born to normal weight women
Children born to women with a pregestationally normal BMI and who were not part of a lifestyle intervention programme during pregnancy.

  Eligibility

Ages Eligible for Study:   30 Months to 40 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Three groups of children at the ages of 2.5 til 3 years.

Criteria

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01918423

Locations
Denmark
Department of Endocrinology, Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Mette Tanvig, MD Department of endocrinology, Odense University Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mette Tanvig, Medical Doctor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01918423     History of Changes
Other Study ID Numbers: LiPO-2
Study First Received: August 2, 2013
Last Updated: August 5, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Odense University Hospital:
Childhood adiposity
Metabolic risk factors
Bone mineralization

Additional relevant MeSH terms:
Pediatric Obesity
Nutrition Disorders
Obesity
Overnutrition

ClinicalTrials.gov processed this record on November 20, 2014