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
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
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
NCT ID
NCT03455712
First Posted
February 27, 2018
Last Updated
March 5, 2018
Sponsor
MetroHealth Medical Center
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
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