- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03452215
Mobile Application and Pregnant Patient Knowledge
June 9, 2020 updated by: Allison Reid, University Hospitals Cleveland Medical Center
Impact of Mobile Application on Patient Knowledge of Pregnancy Topics
Randomized controlled trial to investigate the impact of a pregnancy-specific mobile phone application on the knowledge of specific pregnancy topics and guidelines.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- University Hospitals
-
-
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
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 18 years of age or older at time of consent (or 16-17 years of age with guardian present)
- Singleton gestation
Exclusion Criteria:
- Inadequate knowledge of English language
- Inability to read at or above 8th grade level
- Prior diagnosis of eating disorder
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Control
|
Mobile Phone Application Educational Resources
|
|
Experimental: Study
|
Mobile Phone Application Educational Resources
Mobile Phone Application GWG Tracker
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pregnancy-specific topic/guideline questionnaire
Time Frame: Outcome assessed up to 23 weeks gestation
|
Number of participants who correctly answer
|
Outcome assessed up to 23 weeks gestation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pregnancy-specific questionnaire
Time Frame: Outcome assessed up to 23 weeks gestation
|
Description of general patient population knowledge of pregnancy-specific topics and guidelines.
|
Outcome assessed up to 23 weeks gestation
|
|
Gestational weight gain quantification
Time Frame: Outcome assessed through study completion, an average of 7 months
|
Quantify total gestational weight gain with and without intervention from final documented weight during pregnancy.
|
Outcome assessed through study completion, an average of 7 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
October 9, 2018
Primary Completion (Actual)
May 31, 2019
Study Completion (Actual)
June 30, 2019
Study Registration Dates
First Submitted
January 30, 2018
First Submitted That Met QC Criteria
February 25, 2018
First Posted (Actual)
March 2, 2018
Study Record Updates
Last Update Posted (Actual)
June 11, 2020
Last Update Submitted That Met QC Criteria
June 9, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 01-18-30
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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