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

NCT00530439 | Completed Results

• 1 other identifier: 029
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Obesity; Gestational Weight Gain; Obstetric Complications

Outcome Measures

Primary Outcomes (6)

• Cesarean Section

  At delivery

• Preeclampsia/Pregnancy Induced Hypertension

  Delivery

• Gestational Diabetes Mellitus

  Delivery

• Large for Gestational Age

  Delivery

• Neonatal Intensive Care Unit

  Within 1 month postpartum

• Gestational Weight Gain

  Weight at gestational week 35 - weight by inclusion

  Gestational week 35

Secondary Outcomes (1)

• Metabolic Markers

  Until 6 months post partum

Study Arms (2)

Lifestyle intervention

EXPERIMENTAL

physical activity, dietetic counselling

Other: Lifestyle intervention; Behavioral: Physical activity, dietetic counselling

Control

NO INTERVENTION

Other: Control

Interventions

Lifestyle intervention OTHER

Dietician counselling and physical training

Lifestyle intervention

Control OTHER

Repeated measuring of maternal weight gain, blood samples and ultrasound

Control

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.

Lifestyle intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• singleton pregnant
• BMI \>/= 30 and \</= 45

You may not qualify if:

• Chronic diseases
• Not Danish speaking
• Abuse of alcohol or drugs
• Preterm delivery in earlier pregnancies

Sponsors & Collaborators

• Odense University Hospital: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Odense University Hospital

Odense C, DK-5000, Denmark

Location

Related Publications (6)

• 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.

  PMID: 30061318 DERIVED

• 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.

  PMID: 25343235 DERIVED

• 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.

  PMID: 24989831 DERIVED

• 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.

  PMID: 24834792 DERIVED

• 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.

  PMID: 24586896 DERIVED

• 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.

  PMID: 21972411 DERIVED

MeSH Terms

Conditions

Pregnancy in Obesity; Gestational Weight Gain

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Christina Vinter
• Organization: Odense University Hospital

c.vinter@dadlnet.dk

+45 21782118

Study Officials

• Christina A. Vinter, Ph.d. Student

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2007
• First Posted: September 17, 2007
• Study Start: October 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: July 22, 2011
• Results First Posted: July 14, 2011

Record last verified: 2008-04

Locations

DK (1)