search
Back to results

Impact of GWG Tool on Patient Knowledge

Primary Purpose

Weight Gain, Pregnancy Related

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gestational Weight Gain Card
Sponsored by
MetroHealth Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Weight Gain focused on measuring Pregnancy, Gestational weight gain, Weight gain, Patient education, Patient knowledge, Institute of Medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Standard-of-Care

    Arm Description

    Subjects to receive the Gestational Weight Gain Card at enrollment in addition to standard prenatal care.

    No intervention to be delivered. Subjects to receive standard prenatal care.

    Outcomes

    Primary Outcome Measures

    Pregnancy-specific topic/guideline questionnaire responses
    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.

    Secondary Outcome Measures

    Pregnancy-specific topic/guideline questionnaire responses
    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.

    Full Information

    First Posted
    February 27, 2018
    Last Updated
    March 5, 2018
    Sponsor
    MetroHealth Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03455712
    Brief Title
    Impact of GWG Tool on Patient Knowledge
    Official Title
    Impact of a Patient Education Intervention on Maternal Knowledge of Gestational Weight Gain Recommendations
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 27, 2016 (Actual)
    Primary Completion Date
    November 1, 2016 (Actual)
    Study Completion Date
    September 7, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    MetroHealth Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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'.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weight Gain, Pregnancy Related
    Keywords
    Pregnancy, Gestational weight gain, Weight gain, Patient education, Patient knowledge, Institute of Medicine

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Subjects to be enrolled into the intervention and standard-of-care groups depending on their gestational age at the time of consent during the expected 2 month period of enrollment. Any subject who is between 6 weeks 0 days and 14 weeks 6 days of pregnancy at the time of consent and who has had no prior prenatal visits will be enrolled in the intervention group. Any subject who is between 15 weeks 0 days to 22 weeks 6 days of pregnancy at the time of consent and who has had at least one prior prenatal visit will be enrolled in the control group.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    140 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Subjects to receive the Gestational Weight Gain Card at enrollment in addition to standard prenatal care.
    Arm Title
    Standard-of-Care
    Arm Type
    No Intervention
    Arm Description
    No intervention to be delivered. Subjects to receive standard prenatal care.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Gestational Weight Gain Card
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Pregnancy-specific topic/guideline questionnaire responses
    Description
    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.
    Time Frame
    Outcome assessed up to 23 weeks gestation
    Secondary Outcome Measure Information:
    Title
    Pregnancy-specific topic/guideline questionnaire responses
    Description
    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.
    Time Frame
    Outcome assessed up to 23 weeks gestation

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Erica Berggren, MD, MSCR
    Organizational Affiliation
    Case Western Reserve University School of Medicine, MetroHealth Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Impact of GWG Tool on Patient Knowledge

    We'll reach out to this number within 24 hrs