Impact of GWG Tool on Patient Knowledge

April 23, 2024 updated by: Allie Reid, MetroHealth Medical Center

Impact of a Patient Education Intervention on Maternal Knowledge of Gestational Weight Gain Recommendations

Women with singleton pregnancies at one outpatient clinic to be recruited for controlled clinical trial. Over eight weeks, women 15 0/7--22 6/7 weeks' with at least one prior prenatal visit to be enrolled in the control group. Women 6 0/7--14 6/7 weeks' to be enrolled in the intervention group at their first prenatal visit and to receive a pregnancy-specific gestational weight gain card. Women to be encouraged to record their weight at each prenatal care visit. All women to complete a GWG knowledge--based questionnaire at 15 0/7-22 6/7 weeks'.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Singleton gestation
  • Primary prenatal care at MetroHealth Medical Center
  • Planning to deliver at MetroHealth Medical Center

Exclusion Criteria:

  • Any inclusion criteria not met
  • Prior diagnosis of eating disorder
  • Inadequate knowledge of English language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Subjects to receive the Gestational Weight Gain Card at enrollment in addition to standard prenatal care.
Behavioral: Gestational Weight Gain Card
The Gestational Weight Gain Card is designed to be an educational and weight gain tracking tool. Study subjects will be highly encouraged to use the GWG card to gain both important clinical information and to document weight measurements throughout their pregnancy.
No Intervention: Standard-of-Care
No intervention to be delivered. Subjects to receive standard prenatal care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy-specific topic/guideline questionnaire responses
Time Frame: Outcome assessed up to 23 weeks gestation
Comparison of number of participants in control vs. intervention groups who correctly answer multiple choice and free response questions related to pregnancy-specific topics and guidelines following intervention.
Outcome assessed up to 23 weeks gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy-specific topic/guideline questionnaire responses
Time Frame: Outcome assessed up to 23 weeks gestation
Description of general patient population knowledge of pregnancy-specific topics and guidelines from number of participants who correctly answer multiple choice and free response questions related to pregnancy-specific topics and guidelines prior to intervention.
Outcome assessed up to 23 weeks gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MetroHealth Medical Center

Investigators

  • Principal Investigator: Erica Berggren, MD, MSCR, Case Western Reserve University School of Medicine, MetroHealth Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

September 7, 2017

Study Registration Dates

First Submitted

February 27, 2018

First Submitted That Met QC Criteria

February 28, 2018

First Posted (Actual)

March 6, 2018

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB16-00295

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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