An interventional study of Mobile incentive-based intervention in Maternal; Alcohol Use, Affecting Fetus, sponsored by RTI International. Completed at 1 site in South Africa. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-23.
Sponsored by RTI International · Not applicable, Interventional, and Treatment
This application proposes to develop and test a technology-based behavioral intervention to address maternal alcohol use in South Africa (SA). SA reports the highest per capita rates of alcohol consumption in the world and has one of the world's highest rates of lifelong disorders called fetal alcohol spectrum disorders (FASD). Prenatal alcohol use is often associated with exposure to gender-based violence, and an increase in gender-based violence due to the uncertainty and economic impact of COVID-19 is of a major concern. Recent evidence also showed that alcohol use during lactation significantly compromises child development in children exposed to alcohol through breastfeeding, and the adverse effect of postpartum alcohol use while breastfeeding was independent of prenatal alcohol exposure. Average breastfeeding duration in SA is beyond 1 year, and over 40% of mothers with and without a history of prenatal drinking report alcohol use while breastfeeding. A community-based behavioral intervention involving case management helps reduce prenatal alcohol use but is labor intensive, challenging the feasibility of widespread implementation in economically disadvantaged communities especially during the COVID-19 pandemic with limited social contact. An efficacious behavioral intervention to reduce alcohol use during pregnancy and lactation needs to be developed that is acceptable and feasible in economically disadvantaged communities, for women with transportation difficulties, or during the COVID-19 pandemic with limited social contact. The proposed intervention will incorporate mobile breathalyzer technology, contingent financial incentives, and text-based health promotion and referrals on gender-based violence, maternal infant health, and psychosocial issues including the impact of COVID-19 in the context of maternal alcohol use. Specific aims are (1) to develop and pretest a technology-based behavioral intervention to help women abstain from alcohol use during pregnancy and lactation via formative qualitative research with women who are pregnant or breastfeeding with a recent history of alcohol use, clinic and community stakeholders, and an established Community Collaborative Board in Cape Metropole, SA, and (2) to examine the acceptability and feasibility of the intervention on alcohol use during pregnancy and lactation by pilot testing the mobile technology-based platform with 60 women who are pregnant or postpartum. Acceptability will be assessed at follow-ups, and feasibility will include recruitment capability, process measures, and intervention outcomes. With the evidence of acceptability and feasibility of the proposed intervention, a large randomized clinical trial will become essential to establish efficacy of the intervention. The potential settings that can remotely incorporate the proposed behavioral intervention include primary care clinics, substance use treatment programs, and publicly funded programs for maternal/infant populations in SA, the United States, and other countries.
701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.
This study's enrollment of 60 is below the median of 122 across 607 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →RTI International is the lead sponsor of 84 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Contingent incentives on abstinence from alcohol; Text-based health promotion support
Behavioral: Mobile incentive-based intervention
a technology-based behavioral intervention to address maternal alcohol use with mobile breathalyzer technology or/and urinalysis for biochemical verification of alcohol use, contingent financial incentives on alcohol abstinence, and text-based health promotion.
Urine Ethylglucuronide (EtG) Testing
Number and proportion of participants who were tested negative of alcohol use in urine samples.
Time frame: Baseline
Urine Ethylglucuronide (EtG) Testing
Number and proportion of participants who were tested negative of alcohol use in urine samples.
Time frame: 6 weeks
Urine Ethylglucuronide (EtG) Testing
Number and proportion of participants who were tested negative of alcohol use in urine samples.
Time frame: 3 months
Self-reported Recent Drinking With Timeline Followback
Self-reported use of daily alcohol by the number of standard drinks based on the definition in South Africa (e.g., 12 g per standard drink). The minimum value is 0 and the maximum has no limit in value. The higher the score is, the worse the outcome would be.
Time frame: Baseline
Self-reported Recent Drinking With Timeline Followback
Self-reported use of daily alcohol by the number of standard drinks based on the definition in South Africa (e.g., 12 g per standard drink). The minimum value is 0 and the maximum has no limit in value. The higher the score is, the worse the outcome would be.
Time frame: 6 weeks
Self-reported Recent Drinking With Timeline Followback
Self-reported use of daily alcohol by the number of standard drinks based on the definition in South Africa (e.g., 12 g per standard drink). The minimum value is 0 and the maximum has no limit in value. The higher the score is, the worse the outcome would be.
Time frame: 3 months
| Milestone | Mobile Incentive-based Intervention |
|---|---|
| Started | 60 |
| Completed | 60 |
| Not completed | 0 |
Number and proportion of participants who were tested negative of alcohol use in urine samples.
| Participants | Mobile Incentive-based Intervention |
|---|---|
| Urine Ethylglucuronide (EtG) Testing | 0 |
Number and proportion of participants who were tested negative of alcohol use in urine samples.
| Participants | Mobile Incentive-based Intervention |
|---|---|
| Urine Ethylglucuronide (EtG) Testing | 31 |
Number and proportion of participants who were tested negative of alcohol use in urine samples.
| Participants | Mobile Incentive-based Intervention |
|---|---|
| Urine Ethylglucuronide (EtG) Testing | 31 |
Self-reported use of daily alcohol by the number of standard drinks based on the definition in South Africa (e.g., 12 g per standard drink). The minimum value is 0 and the maximum has no limit in value. The higher the score is, the worse the outcome would be.
| the number of standard drinks per day | Mobile Incentive-based Intervention |
|---|---|
| Self-reported Recent Drinking With Timeline Followback | 9 ± 5.6 |
Self-reported use of daily alcohol by the number of standard drinks based on the definition in South Africa (e.g., 12 g per standard drink). The minimum value is 0 and the maximum has no limit in value. The higher the score is, the worse the outcome would be.
| the number of standard drinks per day | Mobile Incentive-based Intervention |
|---|---|
| Self-reported Recent Drinking With Timeline Followback | 3 ± 5.4 |
Self-reported use of daily alcohol by the number of standard drinks based on the definition in South Africa (e.g., 12 g per standard drink). The minimum value is 0 and the maximum has no limit in value. The higher the score is, the worse the outcome would be.
| the number of standard drinks per day | Mobile Incentive-based Intervention |
|---|---|
| Self-reported Recent Drinking With Timeline Followback | 2 ± 4.9 |
Collected over 3 months per participant. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mobile Incentive-based Intervention | 0/60 (0%) | 5/60 (8.3%) | 2/60 (3.3%) |
| Event | Mobile Incentive-based Intervention |
|---|---|
| MiscarriagePregnancy, puerperium and perinatal conditions | 4/60 |
| neonatal deathPregnancy, puerperium and perinatal conditions | 1/60 |
| Event | Mobile Incentive-based Intervention |
|---|---|
| IntoxicationPsychiatric disorders | 1/60 |
| Abscesses on breastsPregnancy, puerperium and perinatal conditions | 1/60 |
| Age, Categorical(Participants) | Mobile Incentive-based Intervention |
|---|---|
| <=18 years | 6 |
| Between 18 and 65 years | 54 |
| >=65 years | 0 |
| Age, Continuous(years) | Mobile Incentive-based Intervention |
|---|---|
| Mean | 26 ± 6 |
| Sex: Female, Male(Participants) | Mobile Incentive-based Intervention |
|---|---|
| Female | 60 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | Mobile Incentive-based Intervention |
|---|---|
| Race/Ethnicity — Mixed | 46 |
| Race/Ethnicity — Black | 14 |
| Region of Enrollment(participants) | Mobile Incentive-based Intervention |
|---|---|
| South Africa | 60 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — After the main findings are published, we welcome other researchers who want to analyze the data in other ways.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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