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Preventing Alcohol Exposed Pregnancy Among Urban Native Young Women: Mobile CHOICES

Preventing Alcohol Exposed Pregnancy Among Urban Native Young Women: Mobile CHOICES

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04376346
Acronym
WYSE CHOICES
Enrollment
439
Registered
2020-05-06
Start date
2021-08-04
Completion date
2024-02-25
Last updated
2025-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Exposed Pregnancy

Brief 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.

Detailed description

The proposed project builds on a prior NIAAA-funded project which used intensive community-based participatory research (CBPR) methods to adapt CHOICES, an evidence-based brief alcohol-exposed pregnancy (AEP) prevention intervention supported by the CDC, to American Indian Youth CHOICES (AIY-C). AIY-C contains features that make it highly amenable to mHealth approaches, including a framework for integrating diverse cultural teachings, few modules of short duration, and concrete opportunities for goal-setting and achievement. Innovative for this population is the plan to recruit young AIAN women from major urban areas in the US through social media-and to deliver AIY-C via mobile devices, increasingly ubiquitous among AIAN young adults. While social media recruitment and mHealth interventions are not new, only very recently have they been used with AIAN populations. The investigators will partner with urban AIAN organizations to guide us through social media recruitment strategies, mHealth intervention translation and implementation, and evaluation in urban AIAN settings. The investigators propose 3 specific aims: (1) Develop and pilot social-media-based recruitment strategies for urban AIAN young women; (2) translate AIY-C for mHealth delivery through an iterative and theoretically driven process and pilot the developed translated mHealth AIY-C intervention; and (3) recruit 700 (final N=525) urban AIAN young women using identified social media strategies, and conduct an RCT to rigorously evaluate the effectiveness of the mHealth translation of AIY-C for preventing AEP and FASD.

Interventions

BEHAVIORALNative WYSE CHOICES

Native WYSE (Women, Young, Strong, and Empowered) CHOICES (Changing High-risk alcohOl use and Increasing Contraception Effectiveness Study) is an alcohol-exposed pregnancy prevention program that translates CHOICES, an evidence-based targeted intervention, into an mHealth universal intervention for young urban American Indian/Alaska Native (AI/AN) women ages 16-20.

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 20 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Alcohol UseBaselineHad at least one alcoholic drink in past 30 days (Y/N)
Effective Contraceptive UseBaselineEffective contraceptive use (including abstinence), measured by past 30-day vaginal sexual abstinence or, if sexually active, 30 day use of effective contraception at intercourse.

Countries

United States

Participant flow

Pre-assignment details

All eligible participants who signed an informed consent completed a baseline survey (online). Once the survey was complete, participants downloaded a mobile app. Upon opening the app they were randomly assigned to either the intervention or control arm, both available within the same app. All participants enrolled at baseline are invited to participate in each follow-up survey, regardless of participation status of a previous follow-up survey.

Participants by arm

ArmCount
Intervention Arm
Participants in the intervention arm will complete the AIY-C curriculum that has been translated for mHealth delivery. This includes completing various activities such as completing their own risk assessment when it comes to AEP and setting goals for themselves.
218
Control Arm
Participants in the control arm will complete activities that are carefully designed under different topics than the intervention arm. In this regard, participants will complete various activities such as quizzes, interactive games and videos. The investigators will ensure that participants in both arms will spend similar time on completing the activities.
221
Total439

Baseline characteristics

CharacteristicIntervention ArmControl ArmTotal
Age, Continuous18.02 year
STANDARD_DEVIATION 1.39
18.16 year
STANDARD_DEVIATION 1.39
18.09 year
STANDARD_DEVIATION 1.39
Race/Ethnicity, Customized
African American
12 Participants18 Participants30 Participants
Race/Ethnicity, Customized
American Indian/Alaska Native
218 Participants221 Participants439 Participants
Race/Ethnicity, Customized
Asian
9 Participants7 Participants16 Participants
Race/Ethnicity, Customized
Hispanic/Latinx
50 Participants66 Participants116 Participants
Race/Ethnicity, Customized
Missing
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
2 Participants3 Participants5 Participants
Race/Ethnicity, Customized
White/Caucasian
66 Participants66 Participants132 Participants
Sex/Gender, Customized
Female
194 Participants190 Participants384 Participants
Sex/Gender, Customized
Missing
2 Participants0 Participants2 Participants
Sex/Gender, Customized
Non-binary
7 Participants17 Participants24 Participants
Sex/Gender, Customized
Other/not sure
3 Participants5 Participants8 Participants
Sex/Gender, Customized
Trans male
1 Participants1 Participants2 Participants
Sex/Gender, Customized
two-spirit
11 Participants8 Participants19 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2180 / 221
other
Total, other adverse events
0 / 2180 / 221
serious
Total, serious adverse events
0 / 2180 / 221

Outcome results

Primary

Alcohol Use

Had at least one alcoholic drink in past 30 days (Y/N)

Time frame: 6 months

Population: Participants could skip any question on the online survey; we also had attrition at follow-up

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Intervention ArmAlcohol UseYes56 Participants
Intervention ArmAlcohol UseNo97 Participants
Intervention ArmAlcohol UseMissing65 Participants
Control ArmAlcohol UseYes69 Participants
Control ArmAlcohol UseNo86 Participants
Control ArmAlcohol UseMissing66 Participants
Primary

Alcohol Use

Had at least one alcoholic drink in past 30 days (Y/N)

Time frame: 12 months

Population: Participants could skip any question on the online survey; we also had attrition at follow-up

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Intervention ArmAlcohol UseNo84 Participants
Intervention ArmAlcohol UseMissing63 Participants
Intervention ArmAlcohol UseYes71 Participants
Control ArmAlcohol UseNo88 Participants
Control ArmAlcohol UseMissing59 Participants
Control ArmAlcohol UseYes74 Participants
Primary

Alcohol Use

Had at least one alcoholic drink in past 30 days (Y/N)

Time frame: 1 month

Population: Participants could skip any question on the online survey; we also had attrition at follow-up

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Intervention ArmAlcohol UseYes59 Participants
Intervention ArmAlcohol UseNo93 Participants
Intervention ArmAlcohol UseMissing66 Participants
Control ArmAlcohol UseYes60 Participants
Control ArmAlcohol UseNo94 Participants
Control ArmAlcohol UseMissing67 Participants
Primary

Alcohol Use

Had at least one alcoholic drink in past 30 days (Y/N)

Time frame: Baseline

Population: Participants could choose not to answer any question on this online survey

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Intervention ArmAlcohol UseYes86 Participants
Intervention ArmAlcohol UseNo131 Participants
Intervention ArmAlcohol UseMissing1 Participants
Control ArmAlcohol UseYes82 Participants
Control ArmAlcohol UseNo137 Participants
Control ArmAlcohol UseMissing2 Participants
Primary

Effective Contraceptive Use

Effective contraceptive use (including abstinence), measured by past 30-day vaginal sexual abstinence or, if sexually active, 30 day use of effective contraception at intercourse.

Time frame: Baseline

Population: Participants could skip any question on the online survey.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Intervention ArmEffective Contraceptive UseYes209 Participants
Intervention ArmEffective Contraceptive UseMissing0 Participants
Intervention ArmEffective Contraceptive UseNo9 Participants
Control ArmEffective Contraceptive UseMissing1 Participants
Control ArmEffective Contraceptive UseYes197 Participants
Control ArmEffective Contraceptive UseNo23 Participants
Primary

Effective Contraceptive Use

Effective contraceptive use (including abstinence), measured by past 30-day vaginal sexual abstinence or, if sexually active, 30 day use of effective contraception at intercourse.

Time frame: 1 months

Population: Participants could skip any question on the online survey; we also had attrition at follow-up.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Intervention ArmEffective Contraceptive UseYes145 Participants
Intervention ArmEffective Contraceptive UseNo7 Participants
Intervention ArmEffective Contraceptive UseMissing66 Participants
Control ArmEffective Contraceptive UseYes143 Participants
Control ArmEffective Contraceptive UseNo13 Participants
Control ArmEffective Contraceptive UseMissing65 Participants
Primary

Effective Contraceptive Use

Effective contraceptive use (including abstinence), measured by past 30-day vaginal sexual abstinence or, if sexually active, 30 day use of effective contraception at intercourse.

Time frame: 6 months

Population: Participants could skip any question on the online survey; we also had attrition at follow-up.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Intervention ArmEffective Contraceptive UseYes144 Participants
Intervention ArmEffective Contraceptive UseNo10 Participants
Intervention ArmEffective Contraceptive UseMissing64 Participants
Control ArmEffective Contraceptive UseYes140 Participants
Control ArmEffective Contraceptive UseNo15 Participants
Control ArmEffective Contraceptive UseMissing66 Participants
Primary

Effective Contraceptive Use

Effective contraceptive use (including abstinence), measured by past 30-day vaginal sexual abstinence or, if sexually active, 30 day use of effective contraception at intercourse.

Time frame: 12 months

Population: Participants could skip any question on the online survey; we also had attrition at follow-up.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Intervention ArmEffective Contraceptive UseYes146 Participants
Intervention ArmEffective Contraceptive UseNo10 Participants
Intervention ArmEffective Contraceptive UseMissing62 Participants
Control ArmEffective Contraceptive UseYes146 Participants
Control ArmEffective Contraceptive UseNo18 Participants
Control ArmEffective Contraceptive UseMissing57 Participants

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026