Last reviewed · How we verify
BOOST: Breastfeeding Onset and Onward With Support Tools
NA trial testing WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI) in Breastfeeding Duration in 168 participants. Completed in 31 May 2025.
| Lead sponsor | RTI International |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 168 |
| Start date | 19 June 2019 |
| Primary completion | 18 April 2023 |
| Estimated completion | 31 May 2025 |
| Sites | 2 locations across United States |
RTI International — full company profile →
Adults 18 to 44, female only, with Breastfeeding Duration. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Identify breastfeeding behavior via standardized observational method: Identifying audible swallowing, regular suck/swallow/breathe pattern, or visible milk in the infant's mouth.
| Group | Value | 95% CI |
|---|---|---|
| WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC+BFI) | 76 | |
| Standard Care as WIC Support + Home-based Individual Support (SC) | 74 |
Identify breastfeeding behavior via standardized observational method: Identifying audible swallowing, regular suck/swallow/breathe pattern, or visible milk in the infant's mouth.
| Group | Value | 95% CI |
|---|---|---|
| WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI) | 59 | |
| Standard Care as WIC Support + Home-based Individual Support (SC) | 53 |
Identify breastfeeding behavior via standardized observational method: Identifying audible swallowing, regular suck/swallow/breathe pattern, or visible milk in the infant's mouth.
| Group | Value | 95% CI |
|---|---|---|
| WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI) | 46 | |
| Standard Care as WIC Support + Home-based Individual Support (SC) | 33 |
Identify breastfeeding behavior via standardized observational method: Identifying audible swallowing, regular suck/swallow/breathe pattern, or visible milk in the infant's mouth.
| Group | Value | 95% CI |
|---|---|---|
| WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI) | 26 | |
| Standard Care as WIC Support + Home-based Individual Support (SC) | 19 |
Identify breastfeeding behavior via standardized observational method: Identifying audible swallowing, regular suck/swallow/breathe pattern, or visible milk in the infant's mouth.
| Group | Value | 95% CI |
|---|---|---|
| WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI) | 21 | |
| Standard Care as WIC Support + Home-based Individual Support (SC) | 15 |
Measured with a portable digital infant scale.
| Group | Value | 95% CI |
|---|---|---|
| WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI) | 6199 | ± 1003 |
| Standard Care as WIC Support + Home-based Individual Support (SC) | 5921 | ± 886 |
Measured with a portable digital infant scale.
| Group | Value | 95% CI |
|---|---|---|
| WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI) | 8099 | ± 1355 |
| Standard Care as WIC Support + Home-based Individual Support (SC) | 7943 | ± 1136 |
Measured with a portable digital infant scale.
| Group | Value | 95% CI |
|---|---|---|
| WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI) | 9310 | ± 1591 |
| Standard Care as WIC Support + Home-based Individual Support (SC) | 8948 | ± 1151 |
Measured with a portable digital infant scale.
| Group | Value | 95% CI |
|---|---|---|
| WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI) | 10101 | ± 1700 |
| Standard Care as WIC Support + Home-based Individual Support (SC) | 10018 | ± 1422 |
Measured with a portable digital infant scale.
| Group | Value | 95% CI |
|---|---|---|
| WIC Support + Home-based Individual Support + Breastfeeding Incentives (SC + BFI) | 4090 | ± 687 |
| Standard Care as WIC Support + Home-based Individual Support (SC) | 4241 | ± 711 |
Time frame: 12 months per participant. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | WIC Support + Home-based I… | Standard Care as WIC Suppo… |
|---|---|---|---|
| Hospitailzation of participant | Injury, poisoning and procedural complications | — | — |
| Hospitalization of infant | Infections and infestations | — | — |
| Infant death | General disorders | — | — |
| Reaction | System | WIC Support + Home-based I… | Standard Care as WIC Suppo… |
|---|---|---|---|
| Depression | Psychiatric disorders | — | — |
| COVID infection | Infections and infestations | — | — |
| Family death or separation | Social circumstances | — | — |
| Domestic abuse | Psychiatric disorders | — | — |
| Homelessness | Pregnancy, puerperium and perinatal conditions | — | — |
| Miscarriage | Pregnancy, puerperium and perinatal conditions | — | — |
| ER visit | Infections and infestations | — | — |
| Breast cancer or breast issue | Reproductive system and breast disorders | — | — |
| Accident | Musculoskeletal and connective tissue disorders | — | — |
| Incarceration | Social circumstances | — | — |
Most-reported serious reactions: Hospitailzation of participant, Hospitalization of infant, Infant death.
Data from ClinicalTrials.gov NCT03964454 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03964454.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing