Perinatal Outcomes in Nutritionally Monitored Obese Pregnant Women
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Food diary and behavioral model
Intervention type(s): Behavioral
Intervention description(s): 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 intervention name(s): Adherence to prenatal nutritional program
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Perinatal Outcomes; Obesity; Pregnant women