Recruiting

Nutritional Services

Sponsor:

Abington Memorial Hospital

Code:

NCT01713712

Conditions

Pregnancy

Obesity

Eligibility Criteria

Sex: Female

Age: 19 - 40

Healthy Volunteers: Not accepted

Interventions

Nutritional Counseling

Study Details

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.

Conditions

Pregnancy

Obesity

Study ID

NCT01713712

Start date

Dec, 2012

Status verified date

Apr, 2013

Completion date

Feb, 2014

Anticipated

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 19 - 40

Healthy Volunteers: Not accepted

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

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Weight gain [ Time Frame: one year ]

Central Contacts and Locations

Central contacts

Erin M Murphy, MD

215-481-4211emmurphy@amh.org

Bethany Perry, MD

215-481-4211bperry@amh.org

Locations

Abington Memorial Hospital

Recruiting

Abington, Pennsylvania, United States, 19001

Contacts

Erin M Murphy, MD

215-481-4020emmurphy@amh.org

Bethany Perry, MD

215-481-4020bperry@amh.org

Principal Investigator:

Erin M Murphy, MD

Abington Memorial Hospital

Recruiting

Abington, Pennsylvania, United States, 19001

Principal Investigator:

Erin M Murphy, MD

More Information

Sponsor

Abington Memorial Hospital

Last update posted

Apr 22, 2013

Last verified

Apr, 2013

Keywords

  • Pregnancy
  • Obesity
  • Nutrition therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abington Memorial Hospital on 2013-04-22.