NCT01713712

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 25, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

April 22, 2013

Status Verified

April 1, 2013

Enrollment Period

1 year

First QC Date

September 6, 2012

Last Update Submit

April 18, 2013

Conditions

PregnancyObesity

Keywords

PregnancyObesityNutrition therapy

Outcome Measures

Primary Outcomes (1)

  • Weight gain

    change in weight from baseline prepregnancy weight

    one year

Secondary Outcomes (9)

  • Birth weight

    40 weeks

  • Fetal anomalies

    40 weeks

  • Hypertensive disease of pregnancy

    40 weeks

  • Gestational diabetes

    40 weeks

  • Neonatal intensive care admission

    28 days

  • +4 more secondary outcomes

Study Arms (2)

Routine Obstetric Care

NO INTERVENTION

Nutritional Counseling

EXPERIMENTAL

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

Interventions

Nutritional CounselingBEHAVIORAL

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.

Nutritional Counseling

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

RECRUITING

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Erin M Murphy, MD

    Abington Memorial Hospital

    PRINCIPAL INVESTIGATOR

  • Bethany Perry, MD

    Abington Memorial Hospital

    STUDY DIRECTOR

Central Study Contacts

Erin M Murphy, MD

CONTACT

215-481-4211emmurphy@amh.org

Bethany Perry, MD

CONTACT

215-481-4211bperry@amh.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 6, 2012

First Posted

October 25, 2012

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Study Completion

February 1, 2014

Last Updated

April 22, 2013

Record last verified: 2013-04

Locations

US(2)