Access to Nutritional Services and the Effect on Maternal Weight Gain

Not Applicable

• Conditions: Pregnancy; Obesity
• Interventions: Behavioral: Nutritional Counseling

• Registration Number: NCT01713712
• Lead Sponsor: Abington Memorial Hospital

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2012-09-06
• Study First Submitted QC: 2012-10-24
• Study First Posted: 2012-10-25
• Study Start: 2012-12
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-18
• Last Update Posted: 2013-04-22
• Primary Completion: 2013-12
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutritional Counseling	Nutritional Counseling	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.

Primary Outcome Measures

Name	Time	Method
Weight gain	one year	change in weight from baseline prepregnancy weight

Secondary Outcome Measures

Name	Time	Method
Birth weight	40 weeks	Weight of infant at the time of birth
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
APGAR scores	At birth	Measurement at 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

Trial Locations

Locations (1)

Abington Memorial Hospital; 🇺🇸 Abington, Pennsylvania, United States