User Testing and Feedback for a Mobile Health Program for Postpartum Women: A Pilot Study

March 23, 2022 updated by: University of Colorado, Denver
Refine content and delivery of the mHealth delivered lifestyle intervention program through iterative testing with small groups of users who provide feedback through on-line asynchronous focus groups.

Study Overview

Status

Completed

Conditions

Detailed Description

Participants are asked to:

  • Use mobile app for 4 weeks
  • Receive support from the lifestyle coach
  • Provide weekly and ongoing feedback via an online asynchronous user group platform on usability, navigability, acceptability, and satisfaction.

Study Type

Observational

Enrollment (Actual)

26

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

  • United States
    • Colorado
      • Aurora, Colorado, United States
        • University of Colorado Hospital

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Potential participants will be identified via the Perinatal Clinical & Translational Research Center (CTRC) at the University of Colorado at Anschutz Medical Campus.

Description

Inclusion Criteria:

  • Age 18-45
  • Body Mass Index (BMI): 25 - 45 kg/m2

  • Positive history of one or more of the following complications in most recent singleton pregnancy:

    1. Gestational diabetes mellitus
    2. Preeclampsia (high blood pressure and proteinuria diagnosed after 20 weeks gestation)
    3. Gestational hypertension (new hypertension diagnosed after 20 weeks without proteinuria)
    4. Pre-term delivery (32-37 weeks)
    5. Small for gestational age (<10th percentile for gestational age)
  • Able to communicate in English
  • Access to and be willing to use a wi-fi enabled iPhone or iPod
  • Access to a computer with internet access
  • Capable of providing informed consent
  • Between 4 weeks and 24 weeks after delivery

Exclusion Criteria:

  • Personal history of Type 1 or 2 diabetes
  • Personal history of breast cancer or any other type of cancer other than a basal cell skin cancer;
  • Personal history of major chronic illness including cardiovascular disease (coronary artery disease, congestive heart failure, valvular heart disease, stroke, transient ischemic attack, or intermittent claudication), kidney disease, liver disease, venous or arterial thromboembolic disease, adrenal insufficiency, depression requiring hospitalization within the past 6 months, or non-pregnancy related illness requiring overnight hospitalization in the past 6 months;
  • Underlying disease/treatment that might interfere with participation in/completion of the study (e.g. significant gastrointestinal conditions, major psychiatric disorders, and others at the discretion of the study clinician)

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability of the Application
Time Frame: 4 weeks
Usability is defined via Young's Mobile Phone Usability Questionnaire (MPUQ) as how easy the app is to use and how easy it is to learn. The investigators will assess components of usability including: 1) learnability (how easy is it to accomplish basic tasks the first time the app is used?); 2) efficiency (once users can use the app, how quickly can they perform tasks?); 3) memorability (if a user returns to an app after not using it for some time, how easy is it to re-establish proficiency?); 4) errors (how many, how severe, how easy to recover?); and 5) satisfaction (how pleasant is it to use the app?).
4 weeks
Engagement with the Application
Time Frame: 4 weeks
The quantitative assessment of the daily use of the mobile application, including the response to prompts, interactions with lifestyle coach, points earned, and tracking of weight, diet, and physical activity.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Navigability of the Application
Time Frame: 4 weeks
Navigability is defined via Young's Mobile Phone Usability Questionnaire (MPUQ) as whether people can easily and quickly find what they need. The investigators will assess components of navigability including: 1) Is it relatively easy to move from one part of a task to another? 2) Are the operations of this application (app) simple and uncomplicated? 3) Does the app enable the quick, effective, and economical performance of tasks? 4) Is it easy to access the information that you need? 5) Does the app have all the functions and capabilities you expect it to have? 6) Is it easy to navigate between menus and content?
4 weeks
Acceptability of the Application
Time Frame: 4 weeks
Acceptability is defined whether the intended audience finds the content accessible-meaning that it is written in a way that is easily understood and resonant for this population of postpartum women.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Jacinda M Nicklas, MD, MPH, MA, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2015

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

March 4, 2015

First Submitted That Met QC Criteria

March 4, 2015

First Posted (Estimate)

March 10, 2015

Study Record Updates

Last Update Posted (Actual)

March 25, 2022

Last Update Submitted That Met QC Criteria

March 23, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-1173
  • UL1TR001082 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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