Clinical trial NCT02384226: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes Mellitus
Preeclampsia
Gestational Hypertension
Pre-term Delivery
Delivery of Small for Gestational Age (SGA) Baby
Keywords: mobile application
postpartum
weight loss
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-03-10
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Potential participants will be identified via the Perinatal Clinical \& Translational Research Center (CTRC) at the University of Colorado at Anschutz Medical Campus.

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.

Eligibility 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)

Primary outcomes:
measure: Usability of the Application
timeFrame: 4 weeks
measure: Engagement with the Application
timeFrame: 4 weeks
Secondary outcomes:
measure: Navigability of the Application
timeFrame: 4 weeks
measure: Acceptability of the Application
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jacinda M Nicklas, MD, MPH, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.