Access to Nutritional Services and the Effect on Maternal Weight Gain

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Abington Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Erin M. Murphy, MD, Abington Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01713712
First received: September 6, 2012
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Pregnancy
Obesity
Behavioral: Nutritional Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ease of Access to Nutritional Services and the Effect on Maternal Weight in an Obese Urban Population

Resource links provided by NLM:


Further study details as provided by Abington Memorial Hospital:

Primary Outcome Measures:
  • Weight gain [ Time Frame: one year ] [ Designated as safety issue: No ]
    change in weight from baseline prepregnancy weight


Secondary Outcome Measures:
  • Birth weight [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
    Weight of infant at the time of birth

  • Fetal anomalies [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
    Ultrasound findings of fetal anomalies or those detected at birth

  • Hypertensive disease of pregnancy [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
    Development of hypertensive disease during pregnancy

  • Gestational diabetes [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
    Development of gestational diabetes

  • Neonatal intensive care admission [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Admission to neonatal intensive care unit

  • APGAR scores [ Time Frame: At birth ] [ Designated as safety issue: No ]
    Measurement at birth

  • Mode of delivery [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
    vaginal delivery or cesarean section

  • Intrauterine Fetal Demise [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
    Death of fetus prior to delivery

  • Neonatal Death [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Death of neonate from birth to 28 days of life


Estimated Enrollment: 120
Study Start Date: December 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   19 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713712

Contacts
Contact: Erin M Murphy, MD 215-481-4211 emmurphy@amh.org
Contact: Bethany Perry, MD 215-481-4211 bperry@amh.org

Locations
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Erin M Murphy, MD    215-481-4020    emmurphy@amh.org   
Contact: Bethany Perry, MD    215-481-4020    bperry@amh.org   
Principal Investigator: Erin M Murphy, MD         
Sub-Investigator: Bethany Perry, MD         
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Principal Investigator: Erin M Murphy, MD         
Sub-Investigator: Bethany Perry, MD         
Sponsors and Collaborators
Abington Memorial Hospital
Investigators
Principal Investigator: Erin M Murphy, MD Abington Memorial Hospital
Study Director: Bethany Perry, MD Abington Memorial Hospital
  More Information

No publications provided

Responsible Party: Erin M. Murphy, MD, Principal Investigator, Abington Memorial Hospital
ClinicalTrials.gov Identifier: NCT01713712     History of Changes
Other Study ID Numbers: 11-070
Study First Received: September 6, 2012
Last Updated: April 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Abington Memorial Hospital:
Pregnancy
Obesity
Nutrition therapy

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014