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

Completed

• Conditions: Preeclampsia; Pre-term Delivery; Gestational Hypertension; Delivery of Small for Gestational Age (SGA) Baby; Gestational Diabetes Mellitus

• Registration Number: NCT02384226
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

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 Timeline

• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-10
• Study Start: 2015-09
• Primary Completion: 2020-09
• Study Completion: 2020-09
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-23
• Last Update Posted: 2022-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Usability of the Application	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?).
Engagement with the Application	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.

Secondary Outcome Measures

Name	Time	Method
Navigability of the Application	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?
Acceptability of the Application	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.

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States