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BOOST: Breastfeeding Onset and Onward With Support Tools

Individual Breastfeeding Support With Contingent Incentives for Low-Income Mothers

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03964454
Enrollment
168
Registered
2019-05-28
Start date
2019-06-19
Completion date
2025-05-31
Last updated
2026-08-20

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

Conditions

Breastfeeding Duration

Keywords

Breastfeeding duration, WIC, low-income, health incentives

Brief summary

This behavioral intervention trial will test whether a standard care breastfeeding intervention from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program plus monthly financial incentives contingent on observed breastfeeding will improve breastfeeding duration among low-income mothers compared to a standard (WIC) care control. Investigators hypothesize that the standard care plus monthly contingent financial incentives intervention will promote longer breastfeeding duration, fewer infant health issues, and greater healthcare cost savings than the standard care (control) intervention.

Detailed description

Low-income racial/ethnic-minority women have greater challenges with breastfeeding uptake and duration than the general population, resulting in an average breastfeeding duration of four months. This duration is substantially shorter than evidence-based recommendations by the American Academy of Pediatrics to exclusively breastfeed for six months in addition to continued breastfeeding through the first year. Insufficient duration of any breastfeeding is related to multiple maternal and child health problems and increases in breastfeeding duration could be cost saving medically and societally. Even though breastfeeding counseling and peer support have been effective in prolonging breastfeeding duration in the general maternal population, the effect has not been as strong for WIC-eligible (Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)), low-income mothers. Examining novel adjunctive intervention components that could enhance standard WIC counseling and support is warranted. We tested an incentive-based intervention among low-income Puerto Rican mothers in a pilot study. Results suggested strong potential for efficacy of monthly financial incentives contingent on observed breastfeeding for 6 months combined with WIC usual care, compared to WIC usual care only. The current, full-scale randomized trial will test the efficacy and generalizability of the 6-month incentive-based approach to increase breastfeeding duration in WIC-eligible mothers through 12 months. The aims of the study are guided by the mission of NICHD's Pregnancy and Perinatology Branch to improve the long-term maternal and infant health of low-income populations via encouraging breastfeeding in the translational research context. This study is a 2-group, multi-site, parallel randomized controlled trial. The study will be conducted in two regional sites with high concentrations of low-income racial/ethnic minority mothers, Philadelphia, PA and Newark, DE. Participants (n=168) include WIC-eligible mothers who will be allocated into one of the two study groups: (1) A Standard Care Control (SC) group consisting of breastfeeding support through WIC, with home-based individual support, or (2) Standard Care plus Incentives contingent on demonstrating successful breastfeeding (SC+BFI). Participants randomized into SC will receive standard breastfeeding services from WIC plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving. Participants randomized into SC+BFI will receive the same WIC services and monthly home visits as the SC group, with addition of financial incentives following each home visit that are contingent on observed breastfeeding.

Interventions

BEHAVIORALWIC 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.

BEHAVIORALWIC 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.

Sponsors

Philadelphia College of Osteopathic Medicine
Lead SponsorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Temple University
CollaboratorOTHER
Christiana Care Health Services
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Those who are providing home visitations on a monthly basis will be blinded to which condition a participant gets randomized.

Intervention model description

This is a two-group parallel randomized controlled trial testing the efficacy of health incentives to increase breastfeeding duration among low income WIC eligible mothers.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes

Inclusion criteria

* mothers must initiate breastfeeding * mothers must be WIC-enrolled or eligible to enroll in WIC services * mothers must reside and plan to stay in the study county for 12 months postpartum * mothers must consent voluntarily * mothers must understand fifth grade level of English * mothers must be at least 18 years old

Exclusion criteria

* mothers whose babies are medically contraindicated against breastfeeding * mothers who are hospitalized for severe postpartum medical issues * mothers who have ongoing illicit drug use issues * mothers who had a psychiatric hospitalization within the last three months * mothers who currently have suicidal thoughts or attempts

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Breastfeeding Their Infants at 1 Month1 monthIdentify breastfeeding behavior via standardized observational method: Identifying audible swallowing, regular suck/swallow/breathe pattern, or visible milk in the infant's mouth.
Number of Participants Breastfeeding Their Infants at 3 Months3 monthsIdentify breastfeeding behavior via standardized observational method: Identifying audible swallowing, regular suck/swallow/breathe pattern, or visible milk in the infant's mouth.
Number of Participants Breastfeeding Their Infants at 6 Months6 monthsIdentify breastfeeding behavior via standardized observational method: Identifying audible swallowing, regular suck/swallow/breathe pattern, or visible milk in the infant's mouth.
Number of Participants Breastfeeding Their Infants at 9 Months9 monthsIdentify breastfeeding behavior via standardized observational method: Identifying audible swallowing, regular suck/swallow/breathe pattern, or visible milk in the infant's mouth.
Number of Participants Breastfeeding Their Infants at 12 Months12 monthsIdentify breastfeeding behavior via standardized observational method: Identifying audible swallowing, regular suck/swallow/breathe pattern, or visible milk in the infant's mouth.

Secondary

MeasureTime frameDescription
Infant Weight3 monthsMeasured with a portable digital infant scale.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORYukiko Washio, PhD

RTI International

Participant flow

Participants by arm

ArmCount
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.
85
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.
83
Total168

Baseline characteristics

CharacteristicWIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI)Standard Care as WIC Support + Home-based Individual Support (SC)Total
Age, Continuous27.8 years
STANDARD_DEVIATION 6
27.3 years
STANDARD_DEVIATION 5.1
27.6 years
STANDARD_DEVIATION 5.5
Race/Ethnicity, Customized
Hispanic Black
4 Participants4 Participants8 Participants
Race/Ethnicity, Customized
Hispanic Other
21 Participants21 Participants42 Participants
Race/Ethnicity, Customized
Hispanic White
6 Participants5 Participants11 Participants
Race/Ethnicity, Customized
Non-Hispanic Black
47 Participants49 Participants96 Participants
Race/Ethnicity, Customized
Non-Hispanic Other
3 Participants3 Participants6 Participants
Race/Ethnicity, Customized
Non-Hispanic White
4 Participants1 Participants5 Participants
Region of Enrollment
United States
85 participants83 participants168 participants
Relationship status
Married
13 Participants16 Participants29 Participants
Relationship status
Other
7 Participants3 Participants10 Participants
Relationship status
Single, never married
65 Participants64 Participants129 Participants
Sex: Female, Male
Female
85 Participants83 Participants168 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Years of schooling13.1 years
STANDARD_DEVIATION 2.3
13.2 years
STANDARD_DEVIATION 2.1
13.2 years
STANDARD_DEVIATION 2.2

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 850 / 83
other
Total, other adverse events
19 / 8526 / 83
serious
Total, serious adverse events
0 / 855 / 83

Outcome results

Primary

Number of Participants Breastfeeding Their Infants at 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.

Time frame: 12 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI)Number of Participants Breastfeeding Their Infants at 12 Months21 Participants
Standard Care as WIC Support + Home-based Individual Support (SC)Number of Participants Breastfeeding Their Infants at 12 Months15 Participants
Primary

Number of Participants Breastfeeding Their Infants at 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.

Time frame: 1 month

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI)Number of Participants Breastfeeding Their Infants at 1 Month76 Participants
Standard Care as WIC Support + Home-based Individual Support (SC)Number of Participants Breastfeeding Their Infants at 1 Month74 Participants
Primary

Number of Participants Breastfeeding Their Infants at 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.

Time frame: 3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI)Number of Participants Breastfeeding Their Infants at 3 Months59 Participants
Standard Care as WIC Support + Home-based Individual Support (SC)Number of Participants Breastfeeding Their Infants at 3 Months53 Participants
Primary

Number of Participants Breastfeeding Their Infants at 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.

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI)Number of Participants Breastfeeding Their Infants at 6 Months46 Participants
Standard Care as WIC Support + Home-based Individual Support (SC)Number of Participants Breastfeeding Their Infants at 6 Months33 Participants
Primary

Number of Participants Breastfeeding Their Infants at 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.

Time frame: 9 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI)Number of Participants Breastfeeding Their Infants at 9 Months26 Participants
Standard Care as WIC Support + Home-based Individual Support (SC)Number of Participants Breastfeeding Their Infants at 9 Months19 Participants
Secondary

Infant Weight

Measured with a portable digital infant scale.

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI)Infant Weight4090 gramsStandard Deviation 687
Standard Care as WIC Support + Home-based Individual Support (SC)Infant Weight4241 gramsStandard Deviation 711
Secondary

Infant Weight

Measured with a portable digital infant scale.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI)Infant Weight6199 gramsStandard Deviation 1003
Standard Care as WIC Support + Home-based Individual Support (SC)Infant Weight5921 gramsStandard Deviation 886
Secondary

Infant Weight

Measured with a portable digital infant scale.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI)Infant Weight8099 gramsStandard Deviation 1355
Standard Care as WIC Support + Home-based Individual Support (SC)Infant Weight7943 gramsStandard Deviation 1136
Secondary

Infant Weight

Measured with a portable digital infant scale.

Time frame: 9 months

ArmMeasureValue (MEAN)Dispersion
WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI)Infant Weight9310 gramsStandard Deviation 1591
Standard Care as WIC Support + Home-based Individual Support (SC)Infant Weight8948 gramsStandard Deviation 1151
Secondary

Infant Weight

Measured with a portable digital infant scale.

Time frame: 12 months

ArmMeasureValue (MEAN)Dispersion
WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI)Infant Weight10101 gramsStandard Deviation 1700
Standard Care as WIC Support + Home-based Individual Support (SC)Infant Weight10018 gramsStandard Deviation 1422

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026