Access to Nutritional Services and the Effect on Maternal Weight Gain

Abington Memorial Hospital

Status: Unknown

Conditions: Obesity; Pregnancy

Treatments: Behavioral: Nutritional Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT01713712

11-070

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 19 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Routine Obstetric Care

No Intervention group

Nutritional Counseling

Experimental group

Description:

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.

Treatment:

Behavioral: Nutritional Counseling