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Maternal Alcohol Reduction Intervention in South Africa [MaRISA]

Mobile Behavioral Intervention to Reduce Maternal Drinking in South Africa

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05319977
Enrollment
60
Registered
2022-04-11
Start date
2021-03-05
Completion date
2024-02-29
Last updated
2024-08-23

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

Conditions

Maternal; Alcohol Use, Affecting Fetus

Brief summary

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.

Interventions

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.

Sponsors

Medical Research Council, South Africa
CollaboratorOTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
RTI International
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Pregnant (≤28 ges wks) or postpartum (≤3 mos) * Have reported alcohol use during the current pregnancy or lactation * Positive for alcohol use by urinalysis * Have their own mobile phone * Intend to breastfeed for 6 months * Voluntarily consent

Exclusion criteria

* Participated in focus group discussions or pretesting will not be eligible for pilot testing * Serious medical problems threatening their current pregnancy or current suicidal thoughts or attempts in the past month

Design outcomes

Primary

MeasureTime frameDescription
Urine Ethylglucuronide (EtG) TestingBaselineNumber and proportion of participants who were tested negative of alcohol use in urine samples.
Self-reported Recent Drinking With Timeline FollowbackBaselineSelf-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.

Countries

South Africa

Participant flow

Participants by arm

ArmCount
Mobile Incentive-based Intervention
Contingent incentives on abstinence from alcohol; Text-based health promotion support 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.
60
Total60

Baseline characteristics

CharacteristicMobile Incentive-based Intervention
Age, Categorical
<=18 years
6 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
54 Participants
Age, Continuous26 years
STANDARD_DEVIATION 6
Race/Ethnicity, Customized
Race/Ethnicity
Black
14 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Mixed
46 Participants
Region of Enrollment
South Africa
60 participants
Sex: Female, Male
Female
60 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 60
other
Total, other adverse events
2 / 60
serious
Total, serious adverse events
5 / 60

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
Mobile Incentive-based InterventionSelf-reported Recent Drinking With Timeline Followback9 the number of standard drinks per dayStandard Deviation 5.6
Primary

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

ArmMeasureValue (MEAN)Dispersion
Mobile Incentive-based InterventionSelf-reported Recent Drinking With Timeline Followback3 the number of standard drinks per dayStandard Deviation 5.4
Primary

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

ArmMeasureValue (MEAN)Dispersion
Mobile Incentive-based InterventionSelf-reported Recent Drinking With Timeline Followback2 the number of standard drinks per dayStandard Deviation 4.9
Primary

Urine Ethylglucuronide (EtG) Testing

Number and proportion of participants who were tested negative of alcohol use in urine samples.

Time frame: Baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mobile Incentive-based InterventionUrine Ethylglucuronide (EtG) Testing0 Participants
Primary

Urine Ethylglucuronide (EtG) Testing

Number and proportion of participants who were tested negative of alcohol use in urine samples.

Time frame: 6 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mobile Incentive-based InterventionUrine Ethylglucuronide (EtG) Testing31 Participants
Primary

Urine Ethylglucuronide (EtG) Testing

Number and proportion of participants who were tested negative of alcohol use in urine samples.

Time frame: 3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mobile Incentive-based InterventionUrine Ethylglucuronide (EtG) Testing31 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026