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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03455712
Other study ID # IRB16-00295
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 27, 2016
Est. completion date September 7, 2017

Study information

Verified date April 2024
Source MetroHealth Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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'.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date September 7, 2017
Est. primary completion date November 1, 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
MetroHealth Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Outcome assessed up to 23 weeks gestation
Secondary 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. Outcome assessed up to 23 weeks gestation
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