NCT01987141

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 19, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

October 29, 2013

Last Update Submit

May 10, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Patient perception

    At end of pregnancy, average of 40 weeks from enrollment

Study Arms (2)

EMR intervention

EXPERIMENTAL

Patients will have an electronic medical record popup/highlight in their chart, displaying the recommended guidelines for weight gain in pregnancy.

Other: EMR Intervention

Control

NO INTERVENTION

The patient's medical record will be displayed as usual, with no flag or highlight for weight gain recommendations

Interventions

Electronic medical record flag/notification in the patient's chart

EMR intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • They have a multiple gestation pregnancy
  • They are under the age of 18
  • They do not speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 29, 2013

First Posted

November 19, 2013

Study Start

October 1, 2013

Primary Completion

October 1, 2014

Study Completion

May 1, 2016

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations