Trial record 15 of 214 for:    (childhood OR child) AND (female OR girl) AND obesity NOT (male OR men)

Lifestyle in Pregnancy and Offspring (LiPO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mette Tanvig, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01918319
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.


Condition Intervention
Offspring BMI Standard Deviation Score.
Childhood Obesity
Adiposity
Body Composition
Metabolic Risk Factors
Behavioral: Lifestyle intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Lifestyle Intervention in Pregnancy - Follow-up on the Offspring in Early Childhood.

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Body Mass Index standard deviation score [ Time Frame: On average 2.9 years of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fat mass percent [ Time Frame: On average 2.9 years of age ] [ Designated as safety issue: No ]
    Fat mass estimated by dxa scans.


Other Outcome Measures:
  • Anthropometric and metabolic risk factors and 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 measured by dual energy x-ray


Enrollment: 157
Study Start Date: February 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Months to 40 Months
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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: NCT01918319     History of Changes
Other Study ID Numbers: LiPO
Study First Received: August 2, 2013
Last Updated: August 5, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on August 28, 2014