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

• Sponsor: Odense University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00530439
• Collaborator: Aarhus University Hospital (Other)
• Enrollment: 360
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 10

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Maternal Obesity; Gestational Weight Gain; Obstetric Complications	Other: Lifestyle intervention; Other: Control; Behavioral: Physical activity, dietetic counselling	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 360 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lifestyle intervention physical activity, dietetic counselling	Other: Lifestyle intervention; Dietician counselling and physical training; Behavioral: Physical activity, dietetic counselling; 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.
No Intervention: Control	Other: Control; Repeated measuring of maternal weight gain, blood samples and ultrasound

Outcome Measures

Primary Outcome Measures

1. Cesarean Section [At delivery]

2. Preeclampsia/Pregnancy Induced Hypertension [Delivery]

3. Gestational Diabetes Mellitus [Delivery]

4. Large for Gestational Age [Delivery]

5. Neonatal Intensive Care Unit [Within 1 month postpartum]

6. Gestational Weight Gain [Gestational week 35]

   Weight at gestational week 35 - weight by inclusion

Secondary Outcome Measures

1. Metabolic Markers [Until 6 months post partum]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Odense University Hospital	Odense C		Denmark	DK-5000

Sponsors and Collaborators

• Odense University Hospital
• Aarhus University Hospital

Investigators

• Principal Investigator: Christina A. Vinter, Ph.d. Student, Odense University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00530439
• Other Study ID Numbers: 029
• First Posted: Sep 17, 2007
• Last Update Posted: Jul 22, 2011
• Last Verified: Apr 1, 2008

• Additional relevant MeSH terms: Obesity, Maternal; Weight Gain; Gestational Weight Gain

Study Results

Participant Flow

Arm/Group Title	Lifestyle Intervention	Control
Arm/Group Description	physical activity, dietetic counselling
Period Title: Overall Study
STARTED	180	180
COMPLETED	150	154
NOT COMPLETED	30	26

Baseline Characteristics

Arm/Group Title	Lifestyle Intervention	Control	Total
Arm/Group Description	physical activity, dietetic counselling	Total of all reporting groups
Overall Participants	180	180	360
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	180 100%	180 100%	360 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.6 (4.35)	29.05 (4.12)	29.3 (4.2)
Age (Years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Years]	29	29	29
Sex: Female, Male (Count of Participants)
Female	180 100%	180 100%	360 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Denmark	180 100%	180 100%	360 100%

Outcome Measures

1. Primary Outcome

Title	Cesarean Section
Time Frame	At delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

2. Primary Outcome

Title	Preeclampsia/Pregnancy Induced Hypertension
Time Frame	Delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Primary Outcome

Title	Gestational Diabetes Mellitus
Time Frame	Delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Primary Outcome

Title	Large for Gestational Age
Time Frame	Delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Primary Outcome

Title	Neonatal Intensive Care Unit
Time Frame	Within 1 month postpartum

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Metabolic Markers
Time Frame	Until 6 months post partum

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Primary Outcome

Title	Gestational Weight Gain
Description	Weight at gestational week 35 - weight by inclusion
Time Frame	Gestational week 35

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Intervention	Control
Arm/Group Description	physical activity, dietetic counselling
Measure Participants	144	148
Median (Inter-Quartile Range) [kg]	7.0	8.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Intervention, Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.014
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Arm/Group Title	Lifestyle Intervention		Control
Arm/Group Description	physical activity, dietetic counselling
All Cause Mortality
	Lifestyle Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lifestyle Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/180 (0%)		0/180 (0%)
Other (Not Including Serious) Adverse Events
	Lifestyle Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/180 (0%)		0/180 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.