Gestational Weight Gain and the Electronic Medical Record (WATE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Loyola University
Sponsor:
Information provided by (Responsible Party):
Scott Graziano, Loyola University
ClinicalTrials.gov Identifier:
NCT01987141
First received: October 29, 2013
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

Less than one third of pregnant women actually achieve the Institute of Medicine's (IOM) recommended weight gain. To date, there are no randomized controlled trials studying the use of the electronic medical record to alert providers to initiate the counseling of patients on the IOM gestational weight gain recommendations.

In the investigator's planned study intervention, using the EPIC EMR system, an electronic alert (Best Practice Advisory) will appear for providers at each prenatal care visit. This alert will remind providers to counsel patients on the recommendations for gestational weight gain. The control group will receive standard prenatal care, without electronic alerts generated regarding BMI and gestational weight gain.

The investigators hypothesize that a higher percentage of patients who receive the intervention will meet the IOM guidelines for weight gain.


Condition Intervention
Pregnancy
Weight Gain
Other: EMR Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: WATE Study - Gestational Weight Gain and the Electronic Medical Record

Further study details as provided by Loyola University:

Primary Outcome Measures:
  • Weight gain [ Time Frame: At delivery, average of 40 weeks from enrollment ] [ Designated as safety issue: No ]
    Primary outcome will be measured as the percent of patients who achieve their recommended weight gain goal in pregnancy (IOM guidelines)


Secondary Outcome Measures:
  • Patient perception [ Time Frame: At end of pregnancy, average of 40 weeks from enrollment ] [ Designated as safety issue: No ]
    Survey to patients at the end of pregnancy regarding how patients perceive and are influenced by EMR notifications and counseling


Estimated Enrollment: 300
Study Start Date: October 2013
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EMR intervention
Patients will have an electronic medical record popup/highlight in their chart, displaying the recommended guidelines for weight gain in pregnancy.
Other: EMR Intervention
Electronic medical record flag/notification in the patient's chart
No Intervention: Control
The patient's medical record will be displayed as usual, with no flag or highlight for weight gain recommendations

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant with a single intrauterine gestation
  • Present for new OB visit up to 13 weeks and 6 days gestation

Exclusion Criteria:

  • They have a multiple gestation pregnancy
  • They are under the age of 18
  • They do not speak English
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01987141

Contacts
Contact: Scott Graziano, MD MS 708-216-3380 sgrazia@lumc.edu

Locations
United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Scott Graziano, MD MS    708-216-3380    sgrazia@lumc.ed   
Principal Investigator: Scott Graziano, MD MS         
Sponsors and Collaborators
Loyola University
  More Information

No publications provided

Responsible Party: Scott Graziano, Associate Professor, Loyola University
ClinicalTrials.gov Identifier: NCT01987141     History of Changes
Other Study ID Numbers: 205512073013
Study First Received: October 29, 2013
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Weight Gain
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014