Trial Outcomes & Findings for Preventing Alcohol Exposed Pregnancy Among Urban Native Young Women: Mobile CHOICES (NCT NCT04376346)
NCT ID: NCT04376346
Last Updated: 2025-10-16
Results Overview
Had at least one alcoholic drink in past 30 days (Y/N)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
439 participants
Primary outcome timeframe
Baseline
Results posted on
2025-10-16
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
1 Month Follow up
STARTED
|
218
|
221
|
|
1 Month Follow up
COMPLETED
|
159
|
166
|
|
1 Month Follow up
NOT COMPLETED
|
59
|
55
|
|
6 Month Follow up
STARTED
|
218
|
221
|
|
6 Month Follow up
COMPLETED
|
157
|
157
|
|
6 Month Follow up
NOT COMPLETED
|
61
|
64
|
|
12 Month Follow up
STARTED
|
218
|
221
|
|
12 Month Follow up
COMPLETED
|
156
|
164
|
|
12 Month Follow up
NOT COMPLETED
|
62
|
57
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Participants could choose not to answer any question on this online survey
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=218 Participants
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.
|
Control Arm
n=221 Participants
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.
|
Total
n=439 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
18.02 year
STANDARD_DEVIATION 1.39 • n=99 Participants
|
18.16 year
STANDARD_DEVIATION 1.39 • n=107 Participants
|
18.09 year
STANDARD_DEVIATION 1.39 • n=206 Participants
|
|
Sex/Gender, Customized
Female
|
194 Participants
n=99 Participants • Participants could choose not to answer any question on this online survey
|
190 Participants
n=107 Participants • Participants could choose not to answer any question on this online survey
|
384 Participants
n=206 Participants • Participants could choose not to answer any question on this online survey
|
|
Sex/Gender, Customized
Trans male
|
1 Participants
n=99 Participants • Participants could choose not to answer any question on this online survey
|
1 Participants
n=107 Participants • Participants could choose not to answer any question on this online survey
|
2 Participants
n=206 Participants • Participants could choose not to answer any question on this online survey
|
|
Sex/Gender, Customized
Non-binary
|
7 Participants
n=99 Participants • Participants could choose not to answer any question on this online survey
|
17 Participants
n=107 Participants • Participants could choose not to answer any question on this online survey
|
24 Participants
n=206 Participants • Participants could choose not to answer any question on this online survey
|
|
Sex/Gender, Customized
two-spirit
|
11 Participants
n=99 Participants • Participants could choose not to answer any question on this online survey
|
8 Participants
n=107 Participants • Participants could choose not to answer any question on this online survey
|
19 Participants
n=206 Participants • Participants could choose not to answer any question on this online survey
|
|
Sex/Gender, Customized
Other/not sure
|
3 Participants
n=99 Participants • Participants could choose not to answer any question on this online survey
|
5 Participants
n=107 Participants • Participants could choose not to answer any question on this online survey
|
8 Participants
n=206 Participants • Participants could choose not to answer any question on this online survey
|
|
Sex/Gender, Customized
Missing
|
2 Participants
n=99 Participants • Participants could choose not to answer any question on this online survey
|
0 Participants
n=107 Participants • Participants could choose not to answer any question on this online survey
|
2 Participants
n=206 Participants • Participants could choose not to answer any question on this online survey
|
|
Race/Ethnicity, Customized
African American
|
12 Participants
n=99 Participants • Participants could choose not to answer any question on this online survey
|
18 Participants
n=107 Participants • Participants could choose not to answer any question on this online survey
|
30 Participants
n=206 Participants • Participants could choose not to answer any question on this online survey
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
218 Participants
n=99 Participants • Participants could choose not to answer any question on this online survey
|
221 Participants
n=107 Participants • Participants could choose not to answer any question on this online survey
|
439 Participants
n=206 Participants • Participants could choose not to answer any question on this online survey
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=99 Participants • Participants could choose not to answer any question on this online survey
|
7 Participants
n=107 Participants • Participants could choose not to answer any question on this online survey
|
16 Participants
n=206 Participants • Participants could choose not to answer any question on this online survey
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
2 Participants
n=99 Participants • Participants could choose not to answer any question on this online survey
|
3 Participants
n=107 Participants • Participants could choose not to answer any question on this online survey
|
5 Participants
n=206 Participants • Participants could choose not to answer any question on this online survey
|
|
Race/Ethnicity, Customized
Hispanic/Latinx
|
50 Participants
n=99 Participants • Participants could choose not to answer any question on this online survey
|
66 Participants
n=107 Participants • Participants could choose not to answer any question on this online survey
|
116 Participants
n=206 Participants • Participants could choose not to answer any question on this online survey
|
|
Race/Ethnicity, Customized
White/Caucasian
|
66 Participants
n=99 Participants • Participants could choose not to answer any question on this online survey
|
66 Participants
n=107 Participants • Participants could choose not to answer any question on this online survey
|
132 Participants
n=206 Participants • Participants could choose not to answer any question on this online survey
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=99 Participants • Participants could choose not to answer any question on this online survey
|
0 Participants
n=107 Participants • Participants could choose not to answer any question on this online survey
|
1 Participants
n=206 Participants • Participants could choose not to answer any question on this online survey
|
PRIMARY outcome
Timeframe: BaselinePopulation: Participants could choose not to answer any question on this online survey
Had at least one alcoholic drink in past 30 days (Y/N)
Outcome measures
| Measure |
Intervention Arm
n=218 Participants
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.
|
Control Arm
n=221 Participants
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.
|
|---|---|---|
|
Alcohol Use
Yes
|
86 Participants
|
82 Participants
|
|
Alcohol Use
No
|
131 Participants
|
137 Participants
|
|
Alcohol Use
Missing
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Participants could skip any question on the online survey; we also had attrition at follow-up
Had at least one alcoholic drink in past 30 days (Y/N)
Outcome measures
| Measure |
Intervention Arm
n=218 Participants
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.
|
Control Arm
n=221 Participants
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.
|
|---|---|---|
|
Alcohol Use
Yes
|
59 Participants
|
60 Participants
|
|
Alcohol Use
No
|
93 Participants
|
94 Participants
|
|
Alcohol Use
Missing
|
66 Participants
|
67 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Participants could skip any question on the online survey; we also had attrition at follow-up
Had at least one alcoholic drink in past 30 days (Y/N)
Outcome measures
| Measure |
Intervention Arm
n=218 Participants
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.
|
Control Arm
n=221 Participants
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.
|
|---|---|---|
|
Alcohol Use
Yes
|
56 Participants
|
69 Participants
|
|
Alcohol Use
No
|
97 Participants
|
86 Participants
|
|
Alcohol Use
Missing
|
65 Participants
|
66 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Participants could skip any question on the online survey; we also had attrition at follow-up
Had at least one alcoholic drink in past 30 days (Y/N)
Outcome measures
| Measure |
Intervention Arm
n=218 Participants
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.
|
Control Arm
n=221 Participants
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.
|
|---|---|---|
|
Alcohol Use
Yes
|
71 Participants
|
74 Participants
|
|
Alcohol Use
No
|
84 Participants
|
88 Participants
|
|
Alcohol Use
Missing
|
63 Participants
|
59 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Participants could skip any question on the online survey.
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.
Outcome measures
| Measure |
Intervention Arm
n=218 Participants
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.
|
Control Arm
n=221 Participants
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.
|
|---|---|---|
|
Effective Contraceptive Use
Yes
|
209 Participants
|
197 Participants
|
|
Effective Contraceptive Use
No
|
9 Participants
|
23 Participants
|
|
Effective Contraceptive Use
Missing
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 1 monthsPopulation: Participants could skip any question on the online survey; we also had attrition at follow-up.
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.
Outcome measures
| Measure |
Intervention Arm
n=218 Participants
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.
|
Control Arm
n=221 Participants
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.
|
|---|---|---|
|
Effective Contraceptive Use
Yes
|
145 Participants
|
143 Participants
|
|
Effective Contraceptive Use
No
|
7 Participants
|
13 Participants
|
|
Effective Contraceptive Use
Missing
|
66 Participants
|
65 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Participants could skip any question on the online survey; we also had attrition at follow-up.
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.
Outcome measures
| Measure |
Intervention Arm
n=218 Participants
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.
|
Control Arm
n=221 Participants
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.
|
|---|---|---|
|
Effective Contraceptive Use
Yes
|
144 Participants
|
140 Participants
|
|
Effective Contraceptive Use
No
|
10 Participants
|
15 Participants
|
|
Effective Contraceptive Use
Missing
|
64 Participants
|
66 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Participants could skip any question on the online survey; we also had attrition at follow-up.
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.
Outcome measures
| Measure |
Intervention Arm
n=218 Participants
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.
|
Control Arm
n=221 Participants
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.
|
|---|---|---|
|
Effective Contraceptive Use
Yes
|
146 Participants
|
146 Participants
|
|
Effective Contraceptive Use
No
|
10 Participants
|
18 Participants
|
|
Effective Contraceptive Use
Missing
|
62 Participants
|
57 Participants
|
Adverse Events
Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Carol Kaufman
Centers for American Indian and Alaska Native Health, University of Colorado Anschutz Medical Campus
Phone: 303-880-7795
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place