PregnancyWATENCT01987141
Gestational Weight Gain and the Electronic Medical Record
A study testing EMR Intervention in people with Pregnancy and Weight Gain, run by Loyola University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Weight Gain
- What is being tested?
- EMR Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant with a single intrauterine gestation
- Present for new OB visit up to 13 weeks and 6 days gestation
Who cannot join
- They have a multiple gestation pregnancy
- They are under the age of 18
- They do not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
Official title: WATE Study - Gestational Weight Gain and the Electronic Medical Record
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.
- Conditions
- Pregnancy, Weight Gain
- Being tested
- EMR Intervention
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMR InterventionOther
Electronic medical record flag/notification in the patient's chart
| Study group | Role | What they receive |
|---|---|---|
| EMR intervention | Experimental | Patients will have an electronic medical record popup/highlight in their chart, displaying the recommended guidelines for weight gain in pregnancy. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain
Primary outcome will be measured as the percent of patients who achieve their recommended weight gain goal in pregnancy (IOM guidelines)
Measured: At delivery, average of 40 weeks from enrollment
Secondary outcomes (1)
Patient perception
Survey to patients at the end of pregnancy regarding how patients perceive and are influenced by EMR notifications and counseling
Measured: At end of pregnancy, average of 40 weeks from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2014
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Graziano, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987141
- Sponsor's protocol ID
- 205512
- Acronym
- WATE
- Status last verified
- May 2016
- First submitted
- 29 Oct 2013
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WATE Study - Gestational Weight Gain and the Electronic Medical Record
- ClinicalTrials.gov ID
- NCT01987141
- Acronym / sponsor ID
- WATE / 205512
- Conditions
- Pregnancy, Weight Gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 19 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMR intervention | Experimental | Other: EMR InterventionPatients will have an electronic medical record popup/highlight in their chart, displaying the recommended guidelines for weight gain in pregnancy. |
| Control | No intervention | –The patient's medical record will be displayed as usual, with no flag or highlight for weight gain recommendations |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant with a single intrauterine gestation
- Present for new OB visit up to 13 weeks and 6 days gestation
Key exclusion criteria (3 listed)
- They have a multiple gestation pregnancy
- They are under the age of 18
- They do not speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMR InterventionElectronic medical record flag/notification in the patient's chart | Other | EMR intervention |
Primary outcome
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)
1 secondary outcome
Patient perception
Time frame: At end of pregnancy, average of 40 weeks from enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMR Intervention in people with Pregnancy and Weight Gain, run by Loyola University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight gain (time frame: At delivery, average of 40 weeks from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.