NCT03452215

Brief Summary

Randomized controlled trial to investigate the impact of a pregnancy-specific mobile phone application on the knowledge of specific pregnancy topics and guidelines.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 2, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

October 9, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

8 months

First QC Date

January 30, 2018

Last Update Submit

June 9, 2020

Conditions

PregnancyMobile Application

Keywords

PregnancyMobile Phone Application

Outcome Measures

Primary Outcomes (1)

  • Pregnancy-specific topic/guideline questionnaire

    Number of participants who correctly answer

    Outcome assessed up to 23 weeks gestation

Secondary Outcomes (2)

  • Pregnancy-specific questionnaire

    Outcome assessed up to 23 weeks gestation

  • Gestational weight gain quantification

    Outcome assessed through study completion, an average of 7 months

Study Arms (2)

Study

EXPERIMENTAL
Behavioral: Mobile Phone Application Educational ResourcesBehavioral: Mobile Phone Application GWG Tracker

Control

SHAM COMPARATOR
Behavioral: Mobile Phone Application Educational Resources

Interventions

Mobile Phone Application Educational ResourcesBEHAVIORAL

Mobile Phone Application Educational Resources

ControlStudy
Mobile Phone Application GWG TrackerBEHAVIORAL

Mobile Phone Application GWG Tracker

Study

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older at time of consent (or 16-17 years of age with guardian present)
  • Singleton gestation

You may not qualify if:

  • Inadequate knowledge of English language
  • Inability to read at or above 8th grade level
  • Prior diagnosis of eating disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals

Cleveland, Ohio, 44106, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 30, 2018

First Posted

March 2, 2018

Study Start

October 9, 2018

Primary Completion

May 31, 2019

Study Completion

June 30, 2019

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)