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CompletedNCT03964454Updated Aug 20, 2026Results posted

BOOST: Breastfeeding Onset and Onward With Support Tools

An interventional study of WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI) and WIC support + home-based individual support (SC) in Breastfeeding Duration, sponsored by Philadelphia College of Osteopathic Medicine. Completed at 2 sites in United States. Open to female participants aged 18 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Philadelphia College of Osteopathic Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
18 Years to 44 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breastfeeding Duration

Keywords

  • Breastfeeding duration
  • WIC
  • low-income
  • health incentives
03

In context

Lead sponsor

Philadelphia College of Osteopathic Medicine is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 44 Years
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
168 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI)

  • Active comparator
    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.

    Behavioral: WIC support + home-based individual support (SC)

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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. Infant Weight

    Measured with a portable digital infant scale.

    Time frame: 3 months

  2. Infant Weight

    Measured with a portable digital infant scale.

    Time frame: 6 months

  3. Infant Weight

    Measured with a portable digital infant scale.

    Time frame: 9 months

  4. Infant Weight

    Measured with a portable digital infant scale.

    Time frame: 12 months

  5. Infant Weight

    Measured with a portable digital infant scale.

    Time frame: 1 month

07

Results

Posted Jan 1, 2025

Participant flow

Participant flow — Overall Study
MilestoneWIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI)Standard Care as WIC Support + Home-based Individual Support (SC)
Started8583
Completed6865
Not completed1718
Withdrew: Lost to follow-up138
Withdrew: Withdrawal by subject410

Outcome measures

PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants Breastfeeding Their Infants at 1 Month
ParticipantsWIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI)Standard Care as WIC Support + Home-based Individual Support (SC)
Number of Participants Breastfeeding Their Infants at 1 Month8578
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants Breastfeeding Their Infants at 3 Months
ParticipantsWIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI)Standard Care as WIC Support + Home-based Individual Support (SC)
Number of Participants Breastfeeding Their Infants at 3 Months6561
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants Breastfeeding Their Infants at 6 Months
ParticipantsWIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI)Standard Care as WIC Support + Home-based Individual Support (SC)
Number of Participants Breastfeeding Their Infants at 6 Months4535
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants Breastfeeding Their Infants at 9 Months
ParticipantsWIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI)Standard Care as WIC Support + Home-based Individual Support (SC)
Number of Participants Breastfeeding Their Infants at 9 Months3830
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants Breastfeeding Their Infants at 12 Months
ParticipantsWIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI)Standard Care as WIC Support + Home-based Individual Support (SC)
Number of Participants Breastfeeding Their Infants at 12 Months2620
SecondaryInfant Weight

Measured with a portable digital infant scale.

Time frame:
3 months
Reported as:
Mean · grams
Infant Weight
gramsWIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI)Standard Care as WIC Support + Home-based Individual Support (SC)
Infant Weight6199 ± 10035921 ± 886
SecondaryInfant Weight

Measured with a portable digital infant scale.

Time frame:
6 months
Reported as:
Mean · grams
Infant Weight
gramsWIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI)Standard Care as WIC Support + Home-based Individual Support (SC)
Infant Weight8099 ± 13557943 ± 1136
SecondaryInfant Weight

Measured with a portable digital infant scale.

Time frame:
9 months
Reported as:
Mean · grams
Infant Weight
gramsWIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI)Standard Care as WIC Support + Home-based Individual Support (SC)
Infant Weight9310 ± 15918948 ± 1151
SecondaryInfant Weight

Measured with a portable digital infant scale.

Time frame:
12 months
Reported as:
Mean · grams
Infant Weight
gramsWIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI)Standard Care as WIC Support + Home-based Individual Support (SC)
Infant Weight10101 ± 170010018 ± 1422
SecondaryInfant Weight

Measured with a portable digital infant scale.

Time frame:
1 month
Reported as:
Mean · grams
Infant Weight
gramsWIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI)Standard Care as WIC Support + Home-based Individual Support (SC)
Infant Weight4090 ± 6874241 ± 711

Adverse events

Collected over 12 months per participant. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI)0/85 (0%)0/85 (0%)19/85 (22.4%)
Standard Care as WIC Support + Home-based Individual Support (SC)0/83 (0%)5/83 (6%)26/83 (31.3%)
Most frequent serious events
Most frequent serious events
EventWIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI)Standard Care as WIC Support + Home-based Individual Support (SC)
Hospitailzation of participantInjury, poisoning and procedural complications0/852/83
Hospitalization of infantInfections and infestations0/852/83
Infant deathGeneral disorders0/851/83
Most frequent other events
Most frequent other events
EventWIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI)Standard Care as WIC Support + Home-based Individual Support (SC)
DepressionPsychiatric disorders6/8512/83
COVID infectionInfections and infestations0/856/83
Family death or separationSocial circumstances4/850/83
Domestic abusePsychiatric disorders3/852/83
HomelessnessPregnancy, puerperium and perinatal conditions0/852/83
MiscarriagePregnancy, puerperium and perinatal conditions1/852/83
ER visitInfections and infestations2/851/83
Breast cancer or breast issueReproductive system and breast disorders1/851/83
AccidentMusculoskeletal and connective tissue disorders1/850/83
IncarcerationSocial circumstances1/850/83

Baseline characteristics

Age, Continuous
Age, Continuous(years)WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI)Standard Care as WIC Support + Home-based Individual Support (SC)Total
Mean27.8 ± 627.3 ± 5.127.6 ± 5.5
Sex: Female, Male
Sex: Female, Male(Participants)WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI)Standard Care as WIC Support + Home-based Individual Support (SC)Total
Female8583168
Male000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI)Standard Care as WIC Support + Home-based Individual Support (SC)Total
Hispanic White6511
Hispanic Black448
Hispanic Other212142
Non-Hispanic White415
Non-Hispanic Black474996
Non-Hispanic Other336
Region of Enrollment
Region of Enrollment(participants)WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI)Standard Care as WIC Support + Home-based Individual Support (SC)Total
United States8583168
Relationship status
Relationship status(Participants)WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI)Standard Care as WIC Support + Home-based Individual Support (SC)Total
Single, never married6564129
Married131629
Other7310
Years of schooling
Years of schooling(years)WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI)Standard Care as WIC Support + Home-based Individual Support (SC)Total
Mean13.1 ± 2.313.2 ± 2.113.2 ± 2.2
08

Study locations

2 sites
  • Christiana Care Health Services, Inc.
    Newark, Delaware 19718, United States
  • Temple University
    Philadelphia, Pennsylvania 19122, United States
09

References and documents

Publications

  • Washio Y, Collins BN, Hunt-Johnson A, Zhang Z, Herrine G, Hoffman M, Kilby L, Chapman D, Furman LM. Individual breastfeeding support with contingent incentives for low-income mothers in the USA: the 'BOOST (Breastfeeding Onset & Onward with Support Tools)' randomised controlled trial protocol. BMJ Open. 2020 Jun 16;10(6):e034510. doi: 10.1136/bmjopen-2019-034510. PubMed 32554737 ↗

Study documents

  • Protocol and statistical analysis plan · Apr 3, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — A limited data set in which names and other personal health identifiers are removed, as defined by the Health Insurance Portability and Accountability Act (HIPAA), will be supplied to researchers on request.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03964454
Lead sponsor
Philadelphia College of Osteopathic Medicine
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Temple University, Christiana Care Health Services
Responsible party
Yukiko Washio (Research Faculty, Philadelphia College of Osteopathic Medicine) — Principal investigator
First posted
May 28, 2019
Start date
Jun 19, 2019
Primary completion
Apr 18, 2023
Completion
May 31, 2025
Results posted
Jan 1, 2025
Last update
Aug 20, 2026

Study contacts

Yukiko Washio, PhD
principal investigator · RTI International

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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