Access to Nutritional Services and the Effect on Maternal Weight Gain

Study Overview
=================
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.

Official Title
-----------------
Ease of Access to Nutritional Services and the Effect on Maternal Weight in an Obese Urban Population

Conditions
-----------------
Pregnancy, Obesity

Intervention / Treatment
-----------------
* Behavioral: Nutritional Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine Obstetric Care<br> | |
| Experimental: Nutritional Counseling<br>Patients will receive an initial 90 minute nutritional consult followed by 60 minute follow up consults every 2 weeks to monitor weight gain and nutritional status. | Behavioral: Nutritional Counseling<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain | change in weight from baseline prepregnancy weight | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birth weight | Weight of infant at the time of birth | 40 weeks | 
| Fetal anomalies | Ultrasound findings of fetal anomalies or those detected at birth | 40 weeks | 
| Hypertensive disease of pregnancy | Development of hypertensive disease during pregnancy | 40 weeks | 
| Gestational diabetes | Development of gestational diabetes | 40 weeks | 
| Neonatal intensive care admission | Admission to neonatal intensive care unit | 28 days | 
| APGAR scores | Measurement at birth | At birth | 
| Mode of delivery | vaginal delivery or cesarean section | 40 weeks | 
| Intrauterine Fetal Demise | Death of fetus prior to delivery | 40 weeks | 
| Neonatal Death | Death of neonate from birth to 28 days of life | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, Obesity, Nutrition therapy