Gestational Diabetes MellitusNCT02384226
User Testing and Feedback for a Mobile Health Program for Postpartum Women: A Pilot Study
An observational study of Gestational Diabetes Mellitus and Preeclampsia, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus, Preeclampsia, Gestational Hypertension
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Potential participants will be identified via the Perinatal Clinical \& Translational Research Center (CTRC) at the University of Colorado at Anschutz Medical Campus.
Who may be able to join
- 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)
Show all 13Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Gestational Diabetes Mellitus, Preeclampsia, Gestational Hypertension, Pre-term Delivery, Delivery of Small for Gestational Age (SGA) Baby
- Keywords
- mobile application, postpartum, weight loss
- Medical subject headings
- Diabetes, Gestational, Pre-Eclampsia, Hypertension, Pregnancy-Induced, Weight Loss
What is being measured
The primary outcome is the main question the study is designed to answer.
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?).
Measured: 4 weeks
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.
Measured: 4 weeks
Secondary outcomes (2)
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?
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacinda M Nicklas, MD, MPH, MA, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384226
- Sponsor's protocol ID
- 14-1173
- Other IDs
- UL1TR001082
- Status last verified
- Mar 2022
- First submitted
- 4 Mar 2015
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Nicklas JM, Leiferman JA, Lockhart S, Daly KM, Bull SS, Barbour LA. Development and Modification of a Mobile Health Program to Promote Postpartum Weight Loss in Women at Elevated Risk for Cardiometabolic Disease: Single-Arm Pilot Study. JMIR Form Res. 2020 Apr 9;4(4):e16151. doi: 10.2196/16151.
PubMed 32271149
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Testing and Feedback for a Mobile Health Program for Postpartum Women: A Pilot Study
- ClinicalTrials.gov ID
- NCT02384226
- Acronym / sponsor ID
- 14-1173
- Conditions
- Gestational Diabetes Mellitus, Preeclampsia, Gestational Hypertension, Pre-term Delivery, Delivery of Small for Gestational Age (SGA) Baby
- Keywords
- mobile application, postpartum, weight loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 10 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Potential participants will be identified via the Perinatal Clinical \& Translational Research Center (CTRC) at the University of Colorado at Anschutz Medical Campus.
Key inclusion criteria (13 listed)
- 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:
- Able to communicate in English
- Access to and be willing to use a wi-fi enabled iPhone or iPod
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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?).
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.
2 secondary outcomes
Navigability of the Application
Time frame: 4 weeks
Acceptability of the Application
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Derived from this study: PubMed 32271149Nicklas JM, Leiferman JA, Lockhart S, Daly KM, Bull SS, Barbour LA. Development and Modification of a Mobile Health Program to Promote Postpartum Weight Loss in Women at Elevated Risk for Cardiometabolic Disease: Single-Arm Pilot Study. JMIR Form Res. 2020 Apr 9;4(4):e16151. doi: 10.2196/16151.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacinda M Nicklas, MD, MPH, MA principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes Mellitus and Preeclampsia, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the Application (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02384226, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.