Access to Nutritional Services and the Effect on Maternal Weight Gain
Primary Purpose
Pregnancy, Obesity
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutritional Counseling
Sponsored by

About this trial
This is an interventional treatment trial for Pregnancy focused on measuring Pregnancy, Obesity, Nutrition therapy
Eligibility 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
Sites / Locations
- Abington Memorial HospitalRecruiting
- Abington Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Routine Obstetric Care
Nutritional Counseling
Arm Description
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.
Outcomes
Primary Outcome Measures
Weight gain
change in weight from baseline prepregnancy weight
Secondary Outcome Measures
Birth weight
Weight of infant at the time of birth
Fetal anomalies
Ultrasound findings of fetal anomalies or those detected at birth
Hypertensive disease of pregnancy
Development of hypertensive disease during pregnancy
Gestational diabetes
Development of gestational diabetes
Neonatal intensive care admission
Admission to neonatal intensive care unit
APGAR scores
Measurement at birth
Mode of delivery
vaginal delivery or cesarean section
Intrauterine Fetal Demise
Death of fetus prior to delivery
Neonatal Death
Death of neonate from birth to 28 days of life
Full Information
NCT ID
NCT01713712
First Posted
September 6, 2012
Last Updated
April 18, 2013
Sponsor
Abington Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01713712
Brief Title
Access to Nutritional Services and the Effect on Maternal Weight Gain
Official Title
Ease of Access to Nutritional Services and the Effect on Maternal Weight in an Obese Urban Population
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
February 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abington Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Obesity
Keywords
Pregnancy, Obesity, Nutrition therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Routine Obstetric Care
Arm Type
No Intervention
Arm Title
Nutritional Counseling
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutritional Counseling
Intervention Description
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 Information:
Title
Weight gain
Description
change in weight from baseline prepregnancy weight
Time Frame
one year
Secondary Outcome Measure Information:
Title
Birth weight
Description
Weight of infant at the time of birth
Time Frame
40 weeks
Title
Fetal anomalies
Description
Ultrasound findings of fetal anomalies or those detected at birth
Time Frame
40 weeks
Title
Hypertensive disease of pregnancy
Description
Development of hypertensive disease during pregnancy
Time Frame
40 weeks
Title
Gestational diabetes
Description
Development of gestational diabetes
Time Frame
40 weeks
Title
Neonatal intensive care admission
Description
Admission to neonatal intensive care unit
Time Frame
28 days
Title
APGAR scores
Description
Measurement at birth
Time Frame
At birth
Title
Mode of delivery
Description
vaginal delivery or cesarean section
Time Frame
40 weeks
Title
Intrauterine Fetal Demise
Description
Death of fetus prior to delivery
Time Frame
40 weeks
Title
Neonatal Death
Description
Death of neonate from birth to 28 days of life
Time Frame
28 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin M Murphy, MD
Phone
215-481-4211
Email
emmurphy@amh.org
First Name & Middle Initial & Last Name or Official Title & Degree
Bethany Perry, MD
Phone
215-481-4211
Email
bperry@amh.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin M Murphy, MD
Organizational Affiliation
Abington Memorial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bethany Perry, MD
Organizational Affiliation
Abington Memorial Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin M Murphy, MD
Phone
215-481-4020
Email
emmurphy@amh.org
First Name & Middle Initial & Last Name & Degree
Bethany Perry, MD
Phone
215-481-4020
Email
bperry@amh.org
First Name & Middle Initial & Last Name & Degree
Erin M Murphy, MD
First Name & Middle Initial & Last Name & Degree
Bethany Perry, MD
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin M Murphy, MD
First Name & Middle Initial & Last Name & Degree
Bethany Perry, MD
12. IPD Sharing Statement
Learn more about this trial
Access to Nutritional Services and the Effect on Maternal Weight Gain
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