Access to Nutritional Services and the Effect on Maternal Weight Gain

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

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Pregnancy
• Intervention / Treatment: Behavioral: Nutritional Counseling

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin M Murphy, MD; Phone Number: 215-481-4211; Email: emmurphy@amh.org
• Study Contact Backup: Name: Bethany Perry, MD; Phone Number: 215-481-4211; Email: bperry@amh.org

Study Locations

• United States
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Recruiting
      • Abington Memorial Hospital
      • Principal Investigator: Erin M Murphy, MD
      • Sub-Investigator: Bethany Perry, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine Obstetric Care
Experimental: 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.	Behavioral: Nutritional 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.

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

Collaborators and Investigators

• Sponsor: Abington Memorial Hospital
• Investigators: Principal Investigator: Erin M Murphy, MD, Abington Memorial Hospital; Study Director: Bethany Perry, MD, Abington Memorial Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): February 1, 2014

Study Registration Dates

• First Submitted: September 6, 2012
• First Submitted That Met QC Criteria: October 24, 2012
• First Posted (Estimate): October 25, 2012

Study Record Updates

• Last Update Posted (Estimate): April 22, 2013
• Last Update Submitted That Met QC Criteria: April 18, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Obesity; Pregnancy; Nutrition therapy
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 11-070