Gestational Weight Gain and the Electronic Medical Record

Pregnancy Clinical Trial

— WATE  

Official title:

WATE Study - Gestational Weight Gain and the Electronic Medical Record

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01987141
• Other study ID #: 205512
• Status: Recruiting
• Phase: N/A
• First received: October 29, 2013
• Last updated: September 11, 2014
• Start date: October 2013

Study information

• Verified date: September 2014
• Source: Loyola University
• Contact: Scott Graziano, MD MS
• Phone: 708-216-3380
• Email: sgrazia[@]lumc.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy
• Weight Gain

Intervention

Other:
• EMR Intervention
Electronic medical record flag/notification in the patient's chart

Locations

Country	Name	City	State
United States	Loyola University Medical Center	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight gain	Primary outcome will be measured as the percent of patients who achieve their recommended weight gain goal in pregnancy (IOM guidelines)	At delivery, average of 40 weeks from enrollment	No
Secondary	Patient perception	Survey to patients at the end of pregnancy regarding how patients perceive and are influenced by EMR notifications and counseling	At end of pregnancy, average of 40 weeks from enrollment	No