Trial Outcomes & Findings for BOOST: Breastfeeding Onset and Onward With Support Tools (NCT NCT03964454)

NCT ID: NCT03964454

Last Updated: 2025-07-04

Results Overview

Identify breastfeeding behavior via standardized observational method: Identifying audible swallowing, regular suck/swallow/breathe pattern, or visible milk in the infant's mouth.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 168 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2025-07-04

Participant Flow

Participant milestones

Measure	WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI) Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives contingent on observed breastfeeding. WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI): Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives (Breastfeeding Incentives, BFI) contingent on observed breastfeeding.	Standard Care as WIC Support + Home-based Individual Support (SC) Participants randomized into Standard Care (SC) will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving. WIC support + home-based individual support (SC): Participants randomized into SC will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving.
Overall Study STARTED	85	83
Overall Study COMPLETED	68	65
Overall Study NOT COMPLETED	17	18

Reasons for withdrawal

Measure	WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI) Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives contingent on observed breastfeeding. WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI): Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives (Breastfeeding Incentives, BFI) contingent on observed breastfeeding.	Standard Care as WIC Support + Home-based Individual Support (SC) Participants randomized into Standard Care (SC) will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving. WIC support + home-based individual support (SC): Participants randomized into SC will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving.
Overall Study Lost to Follow-up	13	7
Overall Study Withdrawal by Subject	4	11

Baseline Characteristics

BOOST: Breastfeeding Onset and Onward With Support Tools

Baseline characteristics by cohort

Measure	WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI) n=85 Participants Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives contingent on observed breastfeeding. WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI): Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives (Breastfeeding Incentives, BFI) contingent on observed breastfeeding.	Standard Care as WIC Support + Home-based Individual Support (SC) n=83 Participants Participants randomized into Standard Care (SC) will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving. WIC support + home-based individual support (SC): Participants randomized into SC will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving.	Total n=168 Participants Total of all reporting groups
Age, Continuous	27.8 years STANDARD_DEVIATION 6 • n=5 Participants	27.3 years STANDARD_DEVIATION 5.1 • n=7 Participants	27.6 years STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male Female	85 Participants n=5 Participants	83 Participants n=7 Participants	168 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic White	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic Black	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic Other	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic White	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic Black	47 Participants n=5 Participants	49 Participants n=7 Participants	96 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic Other	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	85 participants n=5 Participants	83 participants n=7 Participants	168 participants n=5 Participants
Relationship status Single, never married	65 Participants n=5 Participants	64 Participants n=7 Participants	129 Participants n=5 Participants
Relationship status Married	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants
Relationship status Other	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Years of schooling	13.1 years STANDARD_DEVIATION 2.3 • n=5 Participants	13.2 years STANDARD_DEVIATION 2.1 • n=7 Participants	13.2 years STANDARD_DEVIATION 2.2 • n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Identify breastfeeding behavior via standardized observational method: Identifying audible swallowing, regular suck/swallow/breathe pattern, or visible milk in the infant's mouth.

Outcome measures

Measure	WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI) n=81 Participants Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives contingent on observed breastfeeding. WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI): Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives (Breastfeeding Incentives, BFI) contingent on observed breastfeeding.	Standard Care as WIC Support + Home-based Individual Support (SC) n=80 Participants Participants randomized into Standard Care (SC) will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving. WIC support + home-based individual support (SC): Participants randomized into SC will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving.
Number of Participants Breastfeeding Their Infants at 1 Month	76 Participants	74 Participants

PRIMARY outcome

Timeframe: 3 months

Identify breastfeeding behavior via standardized observational method: Identifying audible swallowing, regular suck/swallow/breathe pattern, or visible milk in the infant's mouth.

Outcome measures

Measure	WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI) n=76 Participants Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives contingent on observed breastfeeding. WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI): Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives (Breastfeeding Incentives, BFI) contingent on observed breastfeeding.	Standard Care as WIC Support + Home-based Individual Support (SC) n=75 Participants Participants randomized into Standard Care (SC) will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving. WIC support + home-based individual support (SC): Participants randomized into SC will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving.
Number of Participants Breastfeeding Their Infants at 3 Months	59 Participants	53 Participants

PRIMARY outcome

Timeframe: 6 months

Identify breastfeeding behavior via standardized observational method: Identifying audible swallowing, regular suck/swallow/breathe pattern, or visible milk in the infant's mouth.

Outcome measures

Measure	WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI) n=76 Participants Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives contingent on observed breastfeeding. WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI): Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives (Breastfeeding Incentives, BFI) contingent on observed breastfeeding.	Standard Care as WIC Support + Home-based Individual Support (SC) n=68 Participants Participants randomized into Standard Care (SC) will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving. WIC support + home-based individual support (SC): Participants randomized into SC will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving.
Number of Participants Breastfeeding Their Infants at 6 Months	46 Participants	33 Participants

PRIMARY outcome

Timeframe: 9 months

Identify breastfeeding behavior via standardized observational method: Identifying audible swallowing, regular suck/swallow/breathe pattern, or visible milk in the infant's mouth.

Outcome measures

Measure	WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI) n=69 Participants Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives contingent on observed breastfeeding. WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI): Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives (Breastfeeding Incentives, BFI) contingent on observed breastfeeding.	Standard Care as WIC Support + Home-based Individual Support (SC) n=66 Participants Participants randomized into Standard Care (SC) will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving. WIC support + home-based individual support (SC): Participants randomized into SC will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving.
Number of Participants Breastfeeding Their Infants at 9 Months	26 Participants	19 Participants

PRIMARY outcome

Timeframe: 12 months

Identify breastfeeding behavior via standardized observational method: Identifying audible swallowing, regular suck/swallow/breathe pattern, or visible milk in the infant's mouth.

Outcome measures

Measure	WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI) n=70 Participants Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives contingent on observed breastfeeding. WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI): Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives (Breastfeeding Incentives, BFI) contingent on observed breastfeeding.	Standard Care as WIC Support + Home-based Individual Support (SC) n=65 Participants Participants randomized into Standard Care (SC) will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving. WIC support + home-based individual support (SC): Participants randomized into SC will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving.
Number of Participants Breastfeeding Their Infants at 12 Months	21 Participants	15 Participants

SECONDARY outcome

Timeframe: 3 months

Measured with a portable digital infant scale.

Outcome measures

Measure	WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI) n=66 Participants Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives contingent on observed breastfeeding. WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI): Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives (Breastfeeding Incentives, BFI) contingent on observed breastfeeding.	Standard Care as WIC Support + Home-based Individual Support (SC) n=68 Participants Participants randomized into Standard Care (SC) will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving. WIC support + home-based individual support (SC): Participants randomized into SC will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving.
Infant Weight	6199 grams Standard Deviation 1003	5921 grams Standard Deviation 886

SECONDARY outcome

Timeframe: 6 months

Measured with a portable digital infant scale.

Outcome measures

Measure	WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI) n=68 Participants Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives contingent on observed breastfeeding. WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI): Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives (Breastfeeding Incentives, BFI) contingent on observed breastfeeding.	Standard Care as WIC Support + Home-based Individual Support (SC) n=61 Participants Participants randomized into Standard Care (SC) will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving. WIC support + home-based individual support (SC): Participants randomized into SC will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving.
Infant Weight	8099 grams Standard Deviation 1355	7943 grams Standard Deviation 1136

SECONDARY outcome

Timeframe: 9 months

Measured with a portable digital infant scale.

Outcome measures

Measure	WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI) n=67 Participants Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives contingent on observed breastfeeding. WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI): Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives (Breastfeeding Incentives, BFI) contingent on observed breastfeeding.	Standard Care as WIC Support + Home-based Individual Support (SC) n=62 Participants Participants randomized into Standard Care (SC) will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving. WIC support + home-based individual support (SC): Participants randomized into SC will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving.
Infant Weight	9310 grams Standard Deviation 1591	8948 grams Standard Deviation 1151

SECONDARY outcome

Timeframe: 12 months

Measured with a portable digital infant scale.

Outcome measures

Measure	WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI) n=65 Participants Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives contingent on observed breastfeeding. WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI): Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives (Breastfeeding Incentives, BFI) contingent on observed breastfeeding.	Standard Care as WIC Support + Home-based Individual Support (SC) n=61 Participants Participants randomized into Standard Care (SC) will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving. WIC support + home-based individual support (SC): Participants randomized into SC will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving.
Infant Weight	10101 grams Standard Deviation 1700	10018 grams Standard Deviation 1422

SECONDARY outcome

Timeframe: 1 month

Measured with a portable digital infant scale.

Outcome measures

Measure	WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI) n=78 Participants Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives contingent on observed breastfeeding. WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI): Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives (Breastfeeding Incentives, BFI) contingent on observed breastfeeding.	Standard Care as WIC Support + Home-based Individual Support (SC) n=75 Participants Participants randomized into Standard Care (SC) will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving. WIC support + home-based individual support (SC): Participants randomized into SC will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving.
Infant Weight	4090 grams Standard Deviation 687	4241 grams Standard Deviation 711

Adverse Events

WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI)

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Standard Care as WIC Support + Home-based Individual Support (SC)

Serious events: 5 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Measure	WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI) n=85 participants at risk Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives contingent on observed breastfeeding. WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI): Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives (Breastfeeding Incentives, BFI) contingent on observed breastfeeding.	Standard Care as WIC Support + Home-based Individual Support (SC) n=83 participants at risk Participants randomized into Standard Care (SC) will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving. WIC support + home-based individual support (SC): Participants randomized into SC will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving.
Injury, poisoning and procedural complications Hospitailzation of participant	0.00% 0/85 • 12 months per participant	2.4% 2/83 • 12 months per participant
Infections and infestations Hospitalization of infant	0.00% 0/85 • 12 months per participant	2.4% 2/83 • 12 months per participant
General disorders Infant death	0.00% 0/85 • 12 months per participant	1.2% 1/83 • 12 months per participant

Other adverse events

Measure	WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI) n=85 participants at risk Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives contingent on observed breastfeeding. WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI): Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives (Breastfeeding Incentives, BFI) contingent on observed breastfeeding.	Standard Care as WIC Support + Home-based Individual Support (SC) n=83 participants at risk Participants randomized into Standard Care (SC) will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving. WIC support + home-based individual support (SC): Participants randomized into SC will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving.
Psychiatric disorders Depression	7.1% 6/85 • 12 months per participant	14.5% 12/83 • 12 months per participant
Pregnancy, puerperium and perinatal conditions Homelessness	0.00% 0/85 • 12 months per participant	2.4% 2/83 • 12 months per participant
Pregnancy, puerperium and perinatal conditions Miscarriage	1.2% 1/85 • 12 months per participant	2.4% 2/83 • 12 months per participant
Infections and infestations COVID infection	0.00% 0/85 • 12 months per participant	7.2% 6/83 • 12 months per participant
Psychiatric disorders Domestic abuse	3.5% 3/85 • 12 months per participant	2.4% 2/83 • 12 months per participant
Infections and infestations ER visit	2.4% 2/85 • 12 months per participant	1.2% 1/83 • 12 months per participant
Reproductive system and breast disorders Breast cancer or breast issue	1.2% 1/85 • 12 months per participant	1.2% 1/83 • 12 months per participant
Musculoskeletal and connective tissue disorders Accident	1.2% 1/85 • 12 months per participant	0.00% 0/83 • 12 months per participant
Social circumstances Family death or separation	4.7% 4/85 • 12 months per participant	0.00% 0/83 • 12 months per participant
Social circumstances Incarceration	1.2% 1/85 • 12 months per participant	0.00% 0/83 • 12 months per participant

Additional Information

Yukiko Washio

RTI International

Phone: 9194852794

Email: ywashio@rti.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place