Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women (LiP)
Primary Purpose
Maternal Obesity, Gestational Weight Gain, Obstetric Complications
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Lifestyle intervention
Control
Physical activity, dietetic counselling
Sponsored by
About this trial
This is an interventional prevention trial for Maternal Obesity
Eligibility Criteria
Inclusion Criteria:
- singleton pregnant
- BMI >/= 30 and </= 45
Exclusion Criteria:
- Chronic diseases
- Not Danish speaking
- Abuse of alcohol or drugs
- Preterm delivery in earlier pregnancies
Sites / Locations
- Odense University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Lifestyle intervention
Control
Arm Description
physical activity, dietetic counselling
Outcomes
Primary Outcome Measures
Cesarean Section
Preeclampsia/Pregnancy Induced Hypertension
Gestational Diabetes Mellitus
Large for Gestational Age
Neonatal Intensive Care Unit
Gestational Weight Gain
Weight at gestational week 35 - weight by inclusion
Secondary Outcome Measures
Metabolic Markers
Full Information
NCT ID
NCT00530439
First Posted
September 13, 2007
Last Updated
July 15, 2011
Sponsor
Odense University Hospital
Collaborators
Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00530439
Brief Title
Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women
Acronym
LiP
Official Title
Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Odense University Hospital
Collaborators
Aarhus University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Obesity is a serious and increasing health problem in the Western World with about one third of all pregnant women in Denmark being overweight. Among these are more than 11% severe obese.
Obesity in pregnancy is related to higher maternal morbidity and perinatal morbidity and mortality. Observational studies indicate that the rate of pregnancy complications among obese pregnant women can be limited if weight gain during pregnancy is restricted.
Aims of the trial is to study the effects of diet and physical training during pregnancy among Danish obese women. Also to describe the metabolic effects of lifestyle intervention during pregnancy.
360 obese pregnant women with Body Mass Index (BMI) > 30 are randomized to lifestyle intervention group or control group. The intervention is composed of individual dietician counselling and physical training. The physical training includes weekly aerobic exercises in a fitness center and lifestyle coaching in small groups.
Both groups will be examined during pregnancy with extra ultrasound scanning of the fetus, blood pressure, and metabolic markers. All women receive vitamin supplementation to assure sufficient intake.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Obesity, Gestational Weight Gain, Obstetric Complications
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle intervention
Arm Type
Experimental
Arm Description
physical activity, dietetic counselling
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Lifestyle intervention
Intervention Description
Dietician counselling and physical training
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Repeated measuring of maternal weight gain, blood samples and ultrasound
Intervention Type
Behavioral
Intervention Name(s)
Physical activity, dietetic counselling
Intervention 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.
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
Cesarean Section
Time Frame
At delivery
Title
Preeclampsia/Pregnancy Induced Hypertension
Time Frame
Delivery
Title
Gestational Diabetes Mellitus
Time Frame
Delivery
Title
Large for Gestational Age
Time Frame
Delivery
Title
Neonatal Intensive Care Unit
Time Frame
Within 1 month postpartum
Title
Gestational Weight Gain
Description
Weight at gestational week 35 - weight by inclusion
Time Frame
Gestational week 35
Secondary Outcome Measure Information:
Title
Metabolic Markers
Time Frame
Until 6 months post partum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
singleton pregnant
BMI >/= 30 and </= 45
Exclusion Criteria:
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
Christina A. Vinter, Ph.d. Student
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense University Hospital
City
Odense C
ZIP/Postal Code
DK-5000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
30061318
Citation
Vinter CA, Tanvig MH, Christensen MH, Ovesen PG, Jorgensen JS, Andersen MS, McIntyre HD, Jensen DM. Lifestyle Intervention in Danish Obese Pregnant Women With Early Gestational Diabetes Mellitus According to WHO 2013 Criteria Does Not Change Pregnancy Outcomes: Results From the LiP (Lifestyle in Pregnancy) Study. Diabetes Care. 2018 Oct;41(10):2079-2085. doi: 10.2337/dc18-0808. Epub 2018 Jul 30.
Results Reference
derived
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
24989831
Citation
Vinter CA, Jorgensen JS, Ovesen P, Beck-Nielsen H, Skytthe A, Jensen DM. Metabolic effects of lifestyle intervention in obese pregnant women. Results from the randomized controlled trial 'Lifestyle in Pregnancy' (LiP). Diabet Med. 2014 Nov;31(11):1323-30. doi: 10.1111/dme.12548. Epub 2014 Jul 23.
Results Reference
derived
PubMed Identifier
24834792
Citation
Vinter CA, Jensen DM, Ovesen P, Beck-Nielsen H, Tanvig M, Lamont RF, Jorgensen JS. Postpartum weight retention and breastfeeding among obese women from the randomized controlled Lifestyle in Pregnancy (LiP) trial. Acta Obstet Gynecol Scand. 2014 Aug;93(8):794-801. doi: 10.1111/aogs.12429. Epub 2014 Jun 13.
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
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
derived
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Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women
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