Trial Outcomes & Findings for Maternal Alcohol Reduction Intervention in South Africa [MaRISA] (NCT NCT05319977)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Baseline

Results posted on

2024-08-23

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Maternal Alcohol Reduction Intervention in South Africa [MaRISA]

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mobile Incentive-based Intervention n=60 Participants 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.
Age, Categorical <=18 years	6 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	54 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	26 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Mixed	46 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black	14 Participants n=5 Participants
Region of Enrollment South Africa	60 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Outcome measures
Measure	Mobile Incentive-based Intervention n=60 Participants Contingent incentives on abstinence from alcohol; Text-based health promotion support
Urine Ethylglucuronide (EtG) Testing	0 Participants

PRIMARY outcome

Timeframe: 6 weeks

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

Outcome measures

Outcome measures
Measure	Mobile Incentive-based Intervention n=57 Participants Contingent incentives on abstinence from alcohol; Text-based health promotion support
Urine Ethylglucuronide (EtG) Testing	31 Participants

PRIMARY outcome

Timeframe: 3 months

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

Outcome measures

Outcome measures
Measure	Mobile Incentive-based Intervention n=52 Participants Contingent incentives on abstinence from alcohol; Text-based health promotion support
Urine Ethylglucuronide (EtG) Testing	31 Participants

PRIMARY outcome

Timeframe: Baseline

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.

Outcome measures

Outcome measures
Measure	Mobile Incentive-based Intervention n=60 Participants Contingent incentives on abstinence from alcohol; Text-based health promotion support
Self-reported Recent Drinking With Timeline Followback	9 the number of standard drinks per day Standard Deviation 5.6

PRIMARY outcome

Timeframe: 6 weeks

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.

Outcome measures

Outcome measures
Measure	Mobile Incentive-based Intervention n=57 Participants Contingent incentives on abstinence from alcohol; Text-based health promotion support
Self-reported Recent Drinking With Timeline Followback	3 the number of standard drinks per day Standard Deviation 5.4

PRIMARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure	Mobile Incentive-based Intervention n=52 Participants Contingent incentives on abstinence from alcohol; Text-based health promotion support
Self-reported Recent Drinking With Timeline Followback	2 the number of standard drinks per day Standard Deviation 4.9

Adverse Events

Mobile Incentive-based Intervention

Serious events: 5 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mobile Incentive-based Intervention n=60 participants at risk 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.
Pregnancy, puerperium and perinatal conditions neonatal death	1.7% 1/60 • 3 months per participant
Pregnancy, puerperium and perinatal conditions Miscarriage	6.7% 4/60 • 3 months per participant

Other adverse events

Other adverse events
Measure	Mobile Incentive-based Intervention n=60 participants at risk 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.
Psychiatric disorders Intoxication	1.7% 1/60 • 3 months per participant
Pregnancy, puerperium and perinatal conditions Abscesses on breasts	1.7% 1/60 • 3 months per participant

Additional Information

Yukiko Washio

RTI International

Phone: 9194852794

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place