Obesity, Pregnancy
Conditions
Keywords
Pregnancy, Obesity, Nutrition therapy
Brief summary
The purpose of this study is to evaluate the effect of access to nutrition services on pregnancy outcomes in the obese urban population. There are many studies that have shown that obesity has a negative impact on pregnancy. However, currently there are only a few small studies that specifically look at ease of access to nutrition services in an obese urban population and the effect this has on maternal weight gain and pregnancy outcomes. This study will compare two groups of pregnant women with a BMI of 30 or greater. The investigators hypothesize that access to nutritional services will lead to decreased weight gain during pregnancy and improved pregnancy outcomes.
Detailed description
The purpose of this study is to evaluate the effect of access to nutrition services on pregnancy outcomes in the obese urban population. Approximately one fourth of women in the United States are overweight and nearly one third are considered to be obese. Pregnancy places obese women at increased risk for several adverse events in the antepartum, intrapartum, and postpartum period. There are many studies that have shown that obesity in pregnancy has a negative impact on pregnancy. However, currently there are few studies in the United States that specifically look at ease of access to nutrition services in an obese urban population and the effect this has on pregnancy outcomes. This study will be a randomized controlled study that will compare two groups of pregnant women with a BMI of 30 or greater one of which has access to nutritional services along with routine prenatal care while the other gets only routine prenatal care. The investigators hypothesize that the obese parturient who has access to nutritional services will have decreased weight gain during pregnancy and ultimately have improved pregnancy outcomes. This will help to guide future care for the obese parturient in the urban population who may have limited access to services.
Interventions
BEHAVIORALNutritional Counseling
Patients will keep a daily diary of nutritional intake as well as physical activity. They will also follow up with the nutritional counselor six weeks postpartum.
Sponsors
Abington Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* primigravid women * age 19-40yrs * less than or equal to 18 weeks gestation at time of enrollment * body mass index (BMI) greater than or equal to 30
Exclusion criteria
* multiparous women * less than 19 yrs of age or older than 40 * greater than 18 weeks gestation at time of enrollment * body mass index (BMI) less than 30 * any significant past medical history including hypertension, diabetes, renal disease, coagulopathy * past surgical history of gastric bypass/weight loss surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight gain | one year | change in weight from baseline prepregnancy weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fetal anomalies | 40 weeks | Ultrasound findings of fetal anomalies or those detected at birth |
| Hypertensive disease of pregnancy | 40 weeks | Development of hypertensive disease during pregnancy |
| Gestational diabetes | 40 weeks | Development of gestational diabetes |
| Neonatal intensive care admission | 28 days | Admission to neonatal intensive care unit |
| Birth weight | 40 weeks | Weight of infant at the time of birth |
| Mode of delivery | 40 weeks | vaginal delivery or cesarean section |
| Intrauterine Fetal Demise | 40 weeks | Death of fetus prior to delivery |
| Neonatal Death | 28 days | Death of neonate from birth to 28 days of life |
| APGAR scores | At birth | Measurement at birth |
Countries
United States
Contacts
Primary ContactErin M Murphy, MD
Backup ContactBethany Perry, MD
Outcome results
None listed