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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02384226
Other study ID # 14-1173
Secondary ID UL1TR001082
Status Completed
Phase
First received
Last updated
Start date September 2015
Est. completion date September 2020

Study information

Verified date March 2022
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date September 2020
Est. primary completion date September 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Locations

Country Name City State
United States University of Colorado Hospital Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Usability of the Application 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
Primary Engagement with the Application 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 Navigability of the Application 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
Secondary Acceptability of the Application 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
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