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Lifestyle in Pregnancy and Offspring (LiPO)

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ClinicalTrials.gov Identifier: NCT01918319
Recruitment Status : Completed
First Posted : August 7, 2013
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):
Mette Tanvig, 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.

Condition or disease Intervention/treatment Phase
Offspring BMI Standard Deviation Score. Childhood Obesity Adiposity Body Composition Metabolic Risk Factors Behavioral: Lifestyle intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Lifestyle Intervention in Pregnancy - Follow-up on the Offspring in Early Childhood.
Study Start Date : February 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Arm Intervention/treatment
Experimental: 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.
Behavioral: Lifestyle intervention
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.
No Intervention: Control



Primary Outcome Measures :
  1. Body Mass Index standard deviation score [ Time Frame: On average 2.9 years of age ]

Secondary Outcome Measures :
  1. Fat mass percent [ Time Frame: On average 2.9 years of age ]
    Fat mass estimated by dxa scans.


Other Outcome Measures:
  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



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Ages Eligible for Study:   30 Months to 40 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01918319


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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mette Tanvig, Medical Doctor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01918319     History of Changes
Other Study ID Numbers: LiPO
First Posted: August 7, 2013    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms