Perinatal Outcomes in Nutritionally Monitored Obese Pregnant Women

This study has been completed.
Sponsor:
Information provided by:
Jamaica Hospital Medical Center
ClinicalTrials.gov Identifier:
NCT00740766
First received: August 22, 2008
Last updated: June 4, 2009
Last verified: June 2009
  Purpose

The aim of this prospective randomized study is the prevention of excessive weight gain in obese pregnant women. The study will compare perinatal outcomes of obese pregnant women treated in the traditional way to outcomes of nutritionally monitored obese pregnant women and evaluate a preliminary behavioral model applicable to the general practice of obstetrics.


Condition Intervention
Obesity
Behavioral: Food diary and behavioral model

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Perinatal Outcomes in Nutritionally Monitored Obese Pregnant Women

Resource links provided by NLM:


Further study details as provided by Jamaica Hospital Medical Center:

Primary Outcome Measures:
  • Mean weight gain Proportion with excessive weight gain (greater than 15 pounds) Mean postpartum weight increment Newborn birthweight and length, controlled for gestational age Proportion of macrosomia Incidence of co-morbidities [ Time Frame: From entry until 6-weeks postpartum ] [ Designated as safety issue: No ]

Enrollment: 257
Study Start Date: June 1998
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Monitored Behavioral: Food diary and behavioral model

The monitored group is to be placed on a prenatal nutritional program consisting of 18 to 24 kcal. per kg. (according to the patient's actual weight) with monitoring each visit.

The patients will be weighed each prenatal visit with the monitored patients weighed and blinded to their actual weight (being weighed with her back to the scale). The monitored patients will be requested not to weigh at home and all patients will be asked to wear similar clothing at each visit.

All intervention (monitored) group women will be asked to record in a diary all of the foods eaten during each day. These records will be reviewed at each prenatal visit. Six weeks after delivery, the patient will be weighed and will then exit the study. The food diary notebooks will be collected from each patient at the end of the study.

Other Name: Adherence to prenatal nutritional program
No Intervention: Unmonitored

Detailed Description:

Study Population and Selection:

This study will recruit 200 obese pregnant women at 12 to 28 weeks of gestation with a body mass index (BMI) of greater than 29.9 kg/m2. Women will be eligible if they are pregnant with a single fetus, and are free of diabetes, hypertension, or chronic kidney disease at recruitment.

Methodology:

The patients will be randomized to either traditional or monitored groups. All participants will be counseled at least once regarding conventional prenatal nutrition guidelines. A more detailed dietary intake protocol would be done with the intervention (monitored) group, which would include being placed on a balanced nutritional intake regimen of 18-24 kcal/kg/day (no less than 2000 calories). Each patient will be asked to record in a diary all of the foods she eats during the day, which will be reviewed by the investigator or assignee at each prenatal visit. The patients will be weighed at each prenatal visit with the monitored patients weighed and blinded to their actual weight.

Data analysis:

The two groups will be compared with respect to pregnancy weight gain, proportion of excessive weight gain (greater than 15 pounds), maternal morbidity, intrapartum complications and newborn birthweight. The primary analysis will consist of a two sample t-test comparing the monitored versus non-monitored groups with regard to weight gain at delivery. A secondary analysis using a repeated measures ANOVA will look at weight gain in the two groups from baseline to 6 weeks post partum in order to look at trends over time. Tests of mean contrasts will compare differences between the two groups at each time during and post pregnancy relative to baseline. Additional analyses will be done to look at other outcomes. In the case of continuous variable outcomes (e.g., gestational weight), a student's t-test will be used. while for categorical outcomes (e.g., macrosomia), the chi square test will be used for the comparison. Alpha will be 0.05 for each comparison.

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI greater than 29.9 kg/m2
  • Single fetus

Exclusion Criteria:

  • Diabetes
  • Hypertension or chronic kidney disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740766

Locations
United States, New Jersey
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
United States, New York
Jamaica Hospital Medical Center
New York, New York, United States, 11418
St. Luke's-Roosevelt Hospital
New York, New York, United States, 10025
Sponsors and Collaborators
Jamaica Hospital Medical Center
Investigators
Principal Investigator: Yvonne S Thornton, MD, MPH
  More Information

Publications:
Thornton YS, Smarkola C, Kopacz SM, Ishoof SB. Perinatal Outcomes in Nutritionally Monitored Obese Pregnant Women: A Randomized Clinical Trial. Journal of the National Medical Association 101(6):569-577, 2009.

Responsible Party: Yvonne S. Thornton, M. D., M. P. H., New York Medical College
ClinicalTrials.gov Identifier: NCT00740766     History of Changes
Other Study ID Numbers: IRB#02-017, MMH IRB#R98-05-022, SLRHC IRB#01-138
Study First Received: August 22, 2008
Last Updated: June 4, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Jamaica Hospital Medical Center:
Perinatal Outcomes
Obesity
Pregnant women

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014