Lifestyle in Pregnancy and Offspring (LiPO)
Primary Purpose
Childhood Obesity, Adiposity, Body Composition
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Lifestyle intervention
Sponsored by
About this trial
This is an interventional prevention trial for Childhood Obesity
Eligibility 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
Sites / Locations
- Department of Endocrinology, Odense University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Lifestyle intervention
Control
Arm Description
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.
Outcomes
Primary Outcome Measures
Body Mass Index standard deviation score
Secondary Outcome Measures
Fat mass percent
Fat mass estimated by dxa scans.
Full Information
NCT ID
NCT01918319
First Posted
August 2, 2013
Last Updated
August 30, 2019
Sponsor
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01918319
Brief Title
Lifestyle in Pregnancy and Offspring
Acronym
LiPO
Official Title
The Effect of Lifestyle Intervention in Pregnancy - Follow-up on the Offspring in Early Childhood.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Adiposity, Body Composition, Metabolic Risk Factors
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
157 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention
Intervention Description
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 Outcome Measure Information:
Title
Body Mass Index standard deviation score
Time Frame
On average 2.9 years of age
Secondary Outcome Measure Information:
Title
Fat mass percent
Description
Fat mass estimated by dxa scans.
Time Frame
On average 2.9 years of age
Other Pre-specified Outcome Measures:
Title
Anthropometric and metabolic risk factors and bone mineralization
Description
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
Time Frame
On average 2.9 years of age
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Months
Maximum Age & Unit of Time
40 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette Tanvig, MD
Organizational Affiliation
Department of endocrinology, Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Endocrinology, Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
21972411
Citation
Vinter CA, Jensen DM, Ovesen P, Beck-Nielsen H, Jorgensen JS. The LiP (Lifestyle in Pregnancy) study: a randomized controlled trial of lifestyle intervention in 360 obese pregnant women. Diabetes Care. 2011 Dec;34(12):2502-7. doi: 10.2337/dc11-1150. Epub 2011 Oct 4.
Results Reference
background
PubMed Identifier
25343235
Citation
Tanvig M, Vinter CA, Jorgensen JS, Wehberg S, Ovesen PG, Beck-Nielsen H, Christesen HT, Jensen DM. Effects of lifestyle intervention in pregnancy and anthropometrics at birth on offspring metabolic profile at 2.8 years: results from the Lifestyle in Pregnancy and Offspring (LiPO) study. J Clin Endocrinol Metab. 2015 Jan;100(1):175-83. doi: 10.1210/jc.2014-2675.
Results Reference
derived
PubMed Identifier
24586896
Citation
Tanvig M, Vinter CA, Jorgensen JS, Wehberg S, Ovesen PG, Lamont RF, Beck-Nielsen H, Christesen HT, Jensen DM. Anthropometrics and body composition by dual energy X-ray in children of obese women: a follow-up of a randomized controlled trial (the Lifestyle in Pregnancy and Offspring [LiPO] study). PLoS One. 2014 Feb 24;9(2):e89590. doi: 10.1371/journal.pone.0089590. eCollection 2014.
Results Reference
derived
Learn more about this trial
Lifestyle in Pregnancy and Offspring
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