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OpenTrials
Completed

NCT Number: NCT00530439

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

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.

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Key information

Conditions

Maternal Obesity Body Weight Body Weight Changes Female Urogenital Diseases and Pregnancy Complications Gestational Weight Gain Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obstetric Complications Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnancy in Obesity Signs and Symptoms Urogenital Diseases Weight Gain

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital

Odense C, DK-5000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lifestyle intervention

Other

Dietician counselling and physical training

Control

Other

Repeated measuring of maternal weight gain, blood samples and ultrasound

Physical activity, dietetic counselling

Behavioral

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 outcomes

  1. Cesarean Section

    Time frame: At delivery

  2. Preeclampsia/Pregnancy Induced Hypertension

    Time frame: Delivery

  3. Gestational Diabetes Mellitus

    Time frame: Delivery

  4. Large for Gestational Age

    Time frame: Delivery

  5. Neonatal Intensive Care Unit

    Time frame: Within 1 month postpartum

  6. Gestational Weight Gain

    Time frame: Gestational week 35

    Weight at gestational week 35 - weight by inclusion

Secondary outcomes

  1. Metabolic Markers

    Time frame: Until 6 months post partum

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Aarhus University Hospital

Registry information

Acronym: LiP

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Sep 17, 2007
Registry last updated
Jul 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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