Clinical trial NCT01713712: Access to Nutritional Services and the Effect on Maternal Weight Gain
Official title: Ease of Access to Nutritional Services and the Effect on Maternal Weight in an Obese Urban Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Obesity
Keywords: Pregnancy
Obesity
Nutrition therapy
Lead sponsor: Abington Memorial Hospital
Sponsor class: OTHER
First posted: 2012-10-25
Enrollment: 120
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Weight gain
timeFrame: one year
Secondary outcomes:
measure: Birth weight
timeFrame: 40 weeks
measure: Fetal anomalies
timeFrame: 40 weeks
measure: Hypertensive disease of pregnancy
timeFrame: 40 weeks
measure: Gestational diabetes
timeFrame: 40 weeks
measure: Neonatal intensive care admission
timeFrame: 28 days
measure: APGAR scores
timeFrame: At birth
measure: Mode of delivery
timeFrame: 40 weeks
measure: Intrauterine Fetal Demise
timeFrame: 40 weeks
measure: Neonatal Death
timeFrame: 28 days
Other outcomes:
Locations:
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
Study officials:
affiliation: Abington Memorial Hospital
name: Erin M Murphy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abington Memorial Hospital
name: Bethany Perry, MD
role: STUDY_DIRECTOR
References: