Access to Nutritional Services and the Effect on Maternal... | NCT01713712

Studies
Access to Nutritional Services and the Effect on Maternal Weight Gain

NCT01713712

Sponsor

Abington Memorial Hospital

Status

Unknown status

Last Update Posted

Apr 22, 2013Estimated

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Pregnancy
Obesity

Interventions

Nutritional Counseling

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Dec 2013Estimated

Completion Date

Feb 2014Estimated

First Submitted Date

Sep 6, 2012

First Submission Date that Met QC Criteria

Oct 24, 2012

First Posted Date

Oct 25, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2013

Last Update Posted Date

Apr 22, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Erin M. Murphy, MD, Principal Investigator, Abington Memorial HospitalPrincipal Investigator

Lead Sponsor

Abington Memorial HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Nutritional Counseling	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight gain	change in weight from baseline prepregnancy weight	one year

Secondary Outcomes

Measure	Description	Time Frame
Birth weight	Weight of infant at the time of birth	40 weeks
Fetal anomalies	Ultrasound findings of fetal anomalies or those detected at birth

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Erin M Murphy, MD	Contact	215-481-4211		emmurphy@amh.org
Bethany Perry, MD	Contact	215-481-4211		bperry@amh.org

Overall Officials

Name	Affiliation	Role
Erin M Murphy, MD	Abington Memorial Hospital	Principal Investigator
Bethany Perry, MD	Abington Memorial Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abington Memorial Hospital	Recruiting	Abington	Pennsylvania	19001	United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015596	Nutrition Assessment

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided