N/A
N=439
Preventing Alcohol Exposed Pregnancy Among Urban Native Young Women: Mobile CHOICES
Alcohol Exposed Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT04376346 ↗Enrolled (actual)
439
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Alcohol Use — 86; 82; 131; 137 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Native WYSE CHOICES (Behavioral)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alcohol Use |
71; 74; 84; 88; 63; 59 | — |
| PRIMARY Alcohol Use |
71; 74; 84; 88; 63; 59 | — |
| PRIMARY Alcohol Use |
71; 74; 84; 88; 63; 59 | — |
| PRIMARY Alcohol Use |
71; 74; 84; 88; 63; 59 | — |
| PRIMARY Effective Contraceptive Use |
146; 146; 10; 18; 62; 57 | — |
| PRIMARY Effective Contraceptive Use |
146; 146; 10; 18; 62; 57 | — |
| PRIMARY Effective Contraceptive Use |
146; 146; 10; 18; 62; 57 | — |
| PRIMARY Effective Contraceptive Use |
146; 146; 10; 18; 62; 57 | — |
Summary
Fetal Alcohol Syndrome Disorders (FASD) result in lifelong disability and are a leading cause of preventable birth defects in the US. Urban American Indian and Alaska Native (AIAN) young women are at high risk for alcohol exposed pregnancies (AEPs) which can cause FASD. In this project, the inverstigators will test the effectiveness of a culturally adapted mobile health intervention to prevent AEP, using social media to recruit AIAN young women from urban centers across the nation.
Eligibility Criteria
Inclusion Criteria
- Identifies as American Indian or Alaska Native (AIAN)
- Biologically female
- 16-20 years old
- Not pregnant
- Not living in tribal reservation or in an Alaska Native Village
- Live in an urban area that is at least 50,000 in population
- Not breastfeeding
- Has an email account
- Has a smart phone
Exclusion Criteria
- Age 15 or younger, and 21 or older
- Biologically male
- Not AIAN
- Pregnant or breastfeeding women
- People who live on a tribal land or in communities with less than 50,000 in population
- Reside in the state of Alaska (until study obtains local IRB approval)
Data sourced from ClinicalTrials.gov (NCT04376346). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.