PregnancyNCT03452215
Mobile Application and Pregnant Patient Knowledge
A study testing Mobile Phone Application Educational Resources and Mobile Phone Application GWG Tracker in people with Pregnancy and Mobile Application, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
Randomized controlled trial to investigate the impact of a pregnancy-specific mobile phone application on the knowledge of specific pregnancy topics and guidelines. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Pregnancy, Mobile Application
- What is being tested?
- Mobile Phone Application Educational Resources and Mobile Phone Application GWG Tracker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 18 years of age or older at time of consent (or 16-17 years of age with guardian present)
- Singleton gestation
Who cannot join
- Inadequate knowledge of English language
- Inability to read at or above 8th grade level
- Prior diagnosis of eating disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pregnancy, Mobile Application
- Being tested
- Mobile Phone Application Educational Resources, Mobile Phone Application GWG Tracker
- Keywords
- Pregnancy, Mobile Phone Application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Phone Application Educational ResourcesBehavioural
Mobile Phone Application Educational Resources
Mobile Phone Application GWG TrackerBehavioural
Mobile Phone Application GWG Tracker
| Study group | Role | What they receive |
|---|---|---|
| Study | Experimental | Not described Receives: Behavioral: Mobile Phone Application Educational Resources; Behavioral: Mobile Phone Application GWG Tracker |
| Control | Sham comparator | Not described Receives: Behavioral: Mobile Phone Application Educational Resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy-specific topic/guideline questionnaire
Number of participants who correctly answer
Measured: Outcome assessed up to 23 weeks gestation
Secondary outcomes (2)
Pregnancy-specific questionnaire
Description of general patient population knowledge of pregnancy-specific topics and guidelines.
Measured: Outcome assessed up to 23 weeks gestation
Gestational weight gain quantification
Quantify total gestational weight gain with and without intervention from final documented weight during pregnancy.
Measured: Outcome assessed through study completion, an average of 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start9 Oct 2018
- Primary completion31 May 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Reid, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452215
- Sponsor's protocol ID
- 01-18-30
- Status last verified
- Jun 2020
- First submitted
- 30 Jan 2018
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mobile Application on Patient Knowledge of Pregnancy Topics
- ClinicalTrials.gov ID
- NCT03452215
- Acronym / sponsor ID
- 01-18-30
- Conditions
- Pregnancy, Mobile Application
- Keywords
- Pregnancy, Mobile Phone Application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 2 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized controlled trial to investigate the impact of a pregnancy-specific mobile phone application on the knowledge of specific pregnancy topics and guidelines.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Behavioral: Mobile Phone Application Educational Resources, Behavioral: Mobile Phone Application GWG Tracker |
| Control | Sham comparator | Behavioral: Mobile Phone Application Educational Resources |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older at time of consent (or 16-17 years of age with guardian present)
- Singleton gestation
Key exclusion criteria (3 listed)
- Inadequate knowledge of English language
- Inability to read at or above 8th grade level
- Prior diagnosis of eating disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Phone Application Educational ResourcesMobile Phone Application Educational Resources | Behavioural | Control, Study |
| Mobile Phone Application GWG TrackerMobile Phone Application GWG Tracker | Behavioural | Study |
Primary outcome
Pregnancy-specific topic/guideline questionnaire
Time frame: Outcome assessed up to 23 weeks gestation
Number of participants who correctly answer
2 secondary outcomes
Pregnancy-specific questionnaire
Time frame: Outcome assessed up to 23 weeks gestation
Gestational weight gain quantification
Time frame: Outcome assessed through study completion, an average of 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Phone Application Educational Resources and Mobile Phone Application GWG Tracker in people with Pregnancy and Mobile Application, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy-specific topic/guideline questionnaire (time frame: Outcome assessed up to 23 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.