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Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women (LiP)

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ClinicalTrials.gov Identifier: NCT00530439
Recruitment Status : Completed
First Posted : September 17, 2007
Results First Posted : July 14, 2011
Last Update Posted : July 22, 2011
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by:
Odense University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Maternal Obesity
Gestational Weight Gain
Obstetric Complications
Interventions Other: Lifestyle intervention
Other: Control
Behavioral: Physical activity, dietetic counselling
Enrollment 360
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lifestyle Intervention Control
Hide Arm/Group Description physical activity, dietetic counselling [Not Specified]
Period Title: Overall Study
Started 180 180
Completed 150 154
Not Completed 30 26
Reason Not Completed
GDM             9             3
Withdraw             18             14
Missed abortion             1             4
Misclassification             2             0
Twin pregnancy             0             2
Severe malformation/abortion             0             3
Arm/Group Title Lifestyle Intervention Control Total
Hide Arm/Group Description physical activity, dietetic counselling [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 180 180 360
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 180 participants 360 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
180
 100.0%
180
 100.0%
360
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 180 participants 180 participants 360 participants
29.6  (4.35) 29.05  (4.12) 29.3  (4.2)
Age Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 180 participants 180 participants 360 participants
29
(27 to 32)
29
(26 to 32)
29
(26 to 32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 180 participants 360 participants
Female
180
 100.0%
180
 100.0%
360
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Denmark Number Analyzed 180 participants 180 participants 360 participants
180 180 360
1.Primary Outcome
Title Cesarean Section
Hide Description [Not Specified]
Time Frame At delivery
Outcome Measure Data Not Reported
2.Primary Outcome
Title Preeclampsia/Pregnancy Induced Hypertension
Hide Description [Not Specified]
Time Frame Delivery
Outcome Measure Data Not Reported
3.Primary Outcome
Title Gestational Diabetes Mellitus
Hide Description [Not Specified]
Time Frame Delivery
Outcome Measure Data Not Reported
4.Primary Outcome
Title Large for Gestational Age
Hide Description [Not Specified]
Time Frame Delivery
Outcome Measure Data Not Reported
5.Primary Outcome
Title Neonatal Intensive Care Unit
Hide Description [Not Specified]
Time Frame Within 1 month postpartum
Outcome Measure Data Not Reported
6.Primary Outcome
Title Gestational Weight Gain
Hide Description Weight at gestational week 35 - weight by inclusion
Time Frame Gestational week 35
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lifestyle Intervention Control
Hide Arm/Group Description:
physical activity, dietetic counselling
[Not Specified]
Overall Number of Participants Analyzed 144 148
Median (Inter-Quartile Range)
Unit of Measure: kg
7.0
(4.7 to 10.6)
8.6
(5.7 to 11.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lifestyle Intervention, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Metabolic Markers
Hide Description [Not Specified]
Time Frame Until 6 months post partum
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lifestyle Intervention Control
Hide Arm/Group Description physical activity, dietetic counselling [Not Specified]
All-Cause Mortality
Lifestyle Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Lifestyle Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/180 (0.00%)   0/180 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lifestyle Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/180 (0.00%)   0/180 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Christina Vinter
Organization: Odense University Hospital
Phone: +45 21782118
EMail: c.vinter@dadlnet.dk
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Christina Vinter, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00530439    
Other Study ID Numbers: 029
First Submitted: September 13, 2007
First Posted: September 17, 2007
Results First Submitted: June 13, 2011
Results First Posted: July 14, 2011
Last Update Posted: July 22, 2011