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Completed

NCT Number: NCT02384226

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

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.

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Key information

Conditions

Gestational Diabetes Mellitus Body Weight Body Weight Changes Cardiovascular Diseases Delivery of Small for Gestational Age (SGA) Baby Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Hypertension Glucose Metabolism Disorders Hypertension Hypertension, Pregnancy-Induced Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Pre-Eclampsia Pre-term Delivery Preeclampsia Pregnancy Complications Signs and Symptoms Urogenital Diseases Vascular Diseases Weight Loss

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Colorado Hospital

Aurora, Colorado, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Gestational diabetes mellitus
  • Preeclampsia (high blood pressure and proteinuria diagnosed after 20 weeks gestation)
  • Gestational hypertension (new hypertension diagnosed after 20 weeks without proteinuria)
  • Pre-term delivery (32-37 weeks)
  • 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)

Treatment and study plan

Primary outcomes

  1. 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?).

  2. 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.

Secondary outcomes

  1. 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?

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Mar 10, 2015
Registry last updated
Mar 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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