Perinatal Outcomes in Nutritionally Monitored Obese Pregnant Women
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|ClinicalTrials.gov Identifier: NCT00740766|
Recruitment Status : Completed
First Posted : August 25, 2008
Last Update Posted : June 8, 2009
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Food diary and behavioral model||Not Applicable|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||257 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Perinatal Outcomes in Nutritionally Monitored Obese Pregnant Women|
|Study Start Date :||June 1998|
|Actual Primary Completion Date :||May 2005|
|Actual Study Completion Date :||May 2005|
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|
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00740766
|United States, New Jersey|
|Morristown Memorial Hospital|
|Morristown, New Jersey, United States, 07962|
|United States, New York|
|St. Luke's-Roosevelt Hospital|
|New York, New York, United States, 10025|
|Jamaica Hospital Medical Center|
|New York, New York, United States, 11418|
|Principal Investigator:||Yvonne S Thornton, MD, MPH|