Expired Study
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Aurora, Colorado


Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

14-1173


NCT ID:

NCT02384226


Secondary ID:

UL1TR001082


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Colorado, Denver


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

200


Enrollment Type:

Anticipated


Overall Contact Information

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

Study Dates

Start Date:September 2015
Completion Date:December 2019
Completion Type:Anticipated
Primary Completion Date:December 2019
Primary Completion Type:Anticipated
Verification Date:January 2019
Last Changed Date:January 15, 2019
First Received Date:March 4, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Acceptability of the Application
Time Frame:4 weeks
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Navigability of the Application
Time Frame:4 weeks
Safety Issues:False
Description: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 par
Outcome Type:Primary Outcome
Measure:Engagement with the Application
Time Frame:4 weeks
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Usability of the Application
Time Frame:4 weeks
Safety Issues:False
Description: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 ta

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Colorado, Denver

Samples and Retentions

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

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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