Piloting JUN_Pregnancy Mobile Medical App

NCT06636110 | Completed DMC FDA Device

• 1 other identifier: STUDY00000755
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This research activity looks at the safety of an investigational intervention, a mobile health (mHealth) app called JUN, that uses artificial intelligence (AI) to track symptoms and give time-sensitive feedback to pregnant women. JUN is an intervention being developed to provide education and assist with decision making during pregnancy. The researchers hope to learn differences in how effectively the participant use of the app is amongst women with and without criminal justice oversight such as adult probation or parole.

Conditions

Pregnancy Related; Pregnancy

Keywords

Community Supervision; Criminal Justice Oversight; Jun App

Outcome Measures

Primary Outcomes (3)

• Self Rated Abilities for Health Practice (SRAHP)

  The Self Rated Abilities for Health Practices Scale (SRAHP) is a 28-item, 5-point scale to measure self-perceived ability to implement health-promoting behaviors. SRAHP contains four subscales: Exercise, Nutrition, Responsible Health Practice, and Psychological Well Being. Each subscale has seven items. Respondents are asked to rate the extent to which they are able to perform health practices related to these four domains. An example of an item from the Health Practices subscale is "I am able to get help from others when I need it." Items are rated from 0 (not at all) to 4 (completely). Ratings for each subscale are summed to yield subscale scores. Subscale scores are summed to obtain a total score. Total scores range from 0-112. Higher scores indicate greater self-efficacy for health practices.

  Baseline to Post-Intervention survey (approximately 3 months)

• JUN mHealth app Timing

  Timing of use of JUN app.

  Month 1 to Month 3

• JUN mHealth app Frequency

  Frequency of use of the JUN app

  Month 1 to Month 3

Secondary Outcomes (5)

• Accountable Health Communities Health-Related Social Needs Screening (AHC HRSN)

  Baseline to Post-Intervention survey (approximately 3 months)

• Sigma-Related Rejection Scale

  Baseline to Post-Intervention survey (approximately 3 months)

• Abuse Assessment Screening tool (AAS)

  Baseline to Post-Intervention survey (approximately 3 months)

• Patient Health Questionnaire (PHQ)

  Baseline to Post-Intervention survey (approximately 3 months)

• Generalized Anxiety Disorder (GAD2)

  Baseline to Post-Intervention survey (approximately 3 months)

Study Arms (2)

Pregnant without Criminal Justice Oversight

EXPERIMENTAL

Pregnant women who are without criminal justice oversight

Device: Jun mHealth app

Pregnant with Criminal Justice Oversight

EXPERIMENTAL

Pregnant women who are under Community Supervision (CS), on probation or parole with criminal justice oversight

Device: Jun mHealth app

Interventions

Jun mHealth app DEVICE

The intervention will be a mHealth app, JUN, across 3 months during pregnancy.

Also known as: Mobile Medical Health App

Pregnant with Criminal Justice Oversight; Pregnant without Criminal Justice Oversight

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant women in their first 6 months of pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant female 18-50 years
• Within first 6 months of pregnancy
• Either on community supervision or without criminal system involvement
• Located in Texas, Minnesota or Oregon

You may not qualify if:

• Individuals who do not identify as women
• Later pregnancy, beyond the first 6 months

Sponsors & Collaborators

• The University of Texas at San Antonio: collaborator
• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Study Officials

• Allison Ihle, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 selection of pregnant women with and without criminal justice oversight. There will be further random selection of a sub-sample (n=20) (n=10 with and n=10 without criminal justice oversight to interview using Health Belief Model (HBM)

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: March 3, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At the conclusion of this project's period, appropriate plans will be made to maintain data stored on UTHSCSA servers or otherwise upload it to a publicly-available repositor.

Locations

US (1)