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

NCT02384226 | Completed

• 2 other identifiers: 14-1173UL1TR001082
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus; Preeclampsia; Gestational Hypertension; Pre-term Delivery; Delivery of Small for Gestational Age (SGA) Baby

Keywords

mobile application; postpartum; weight loss

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Navigability of the Application

  4 weeks

• Acceptability of the Application

  4 weeks

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, United States

Location

Related Publications (1)

• 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.

  PMID: 32271149 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Weight Loss

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacinda M Nicklas, MD, MPH, MA

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 10, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: March 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)