Access to Nutritional Services and the Effect on Maternal Weight Gain

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01713712
• Other study ID #: 11-070
• Status: Recruiting
• Phase: N/A
• First received: September 6, 2012
• Last updated: April 18, 2013
• Start date: December 2012
• Est. completion date: February 2014

Study information

• Verified date: April 2013
• Source: Abington Memorial Hospital
• Contact: Erin M Murphy, MD
• Phone: 215-481-4211
• Email: emmurphy[@]amh.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Abington Memorial Hospital	Abington	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abington Memorial Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight gain	change in weight from baseline prepregnancy weight	one year	No
Secondary	Birth weight	Weight of infant at the time of birth	40 weeks	No
Secondary	Fetal anomalies	Ultrasound findings of fetal anomalies or those detected at birth	40 weeks	No
Secondary	Hypertensive disease of pregnancy	Development of hypertensive disease during pregnancy	40 weeks	No
Secondary	Gestational diabetes	Development of gestational diabetes	40 weeks	No
Secondary	Neonatal intensive care admission	Admission to neonatal intensive care unit	28 days	No
Secondary	APGAR scores	Measurement at birth	At birth	No
Secondary	Mode of delivery	vaginal delivery or cesarean section	40 weeks	No
Secondary	Intrauterine Fetal Demise	Death of fetus prior to delivery	40 weeks	No
Secondary	Neonatal Death	Death of neonate from birth to 28 days of life	28 days	No