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Gestational Weight Gain and the Electronic Medical Record (WATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01987141
Recruitment Status : Completed
First Posted : November 19, 2013
Last Update Posted : May 12, 2016
Information provided by (Responsible Party):
Scott Graziano, Loyola University

Brief Summary:

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 or disease Intervention/treatment Phase
Pregnancy Weight Gain Other: EMR Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: WATE Study - Gestational Weight Gain and the Electronic Medical Record
Study Start Date : October 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Weight gain [ Time Frame: At delivery, average of 40 weeks from enrollment ]
    Primary outcome will be measured as the percent of patients who achieve their recommended weight gain goal in pregnancy (IOM guidelines)

Secondary Outcome Measures :
  1. Patient perception [ Time Frame: At end of pregnancy, average of 40 weeks from enrollment ]
    Survey to patients at the end of pregnancy regarding how patients perceive and are influenced by EMR notifications and counseling

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01987141

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United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
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Responsible Party: Scott Graziano, Associate Professor, Loyola University Identifier: NCT01987141    
Other Study ID Numbers: 205512
First Posted: November 19, 2013    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Body Weight
Weight Gain
Gestational Weight Gain
Body Weight Changes