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

NCT ID: NCT02384226

Last Updated: 2022-03-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2020-09-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacinda M Nicklas, MD, MPH, MA

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Hospital

Aurora, Colorado, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32271149 (View on PubMed)

Other Identifiers

UL1TR001082

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14-1173

Identifier Type: -

Identifier Source: org_study_id