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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD094877 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Temple University | OTHER |
| Christiana Care Health Services | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SC + BFI | Experimental | 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. |
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| SC | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
| 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. | 3 months |
| 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. | 6 months |
| 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. | 9 months |
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Infant Weight | Measured with a portable digital infant scale. | 3 months |
| Infant Weight | Measured with a portable digital infant scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yukiko Washio, PhD | RTI International | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christiana Care Health Services, Inc. | Newark | Delaware | 19718 | United States | ||
| Temple University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32554737 | Derived | 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. |
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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.
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The data will be made available after the publication of the study results.
Analytic files will be collected in Redcap and then prepared in SPSS, R, SAS, or STATA, with online codebooks giving the variable name, label, type, format, positions, consistency codes, and, if applicable, values and value labels. Requesting access to data will involve drafting an abstract, checking the feasibility relative to the available data, and then seeking the permission of the PI and the team for review, if appropriate. The data sets will be ready for use and can be converted to other analytic tools.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 1 month |
|
12 months per participant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitailzation of participant | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yukiko Washio | RTI International | 9194852794 | ywashio@rti.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 3, 2019 | Jul 24, 2024 | Prot_SAP_000.pdf |
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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.
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Those who are providing home visitations on a monthly basis will be blinded to which condition a participant gets randomized.
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| WIC support + home-based individual support (SC) | Behavioral | 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. |
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| 6 months |
| Infant Weight | Measured with a portable digital infant scale. | 9 months |
| Infant Weight | Measured with a portable digital infant scale. | 12 months |
| Infant Weight | Measured with a portable digital infant scale. | 1 month |
| Philadelphia |
| Pennsylvania |
| 19122 |
| United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Relationship status | Count of Participants | Participants |
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| Years of schooling | Mean | Standard Deviation | years |
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| OG001 | 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. |
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| 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. | Posted | Count of Participants | Participants | 3 months |
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| 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. | Posted | Count of Participants | Participants | 6 months |
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|
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| 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. | Posted | Count of Participants | Participants | 9 months |
|
|
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| 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. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Infant Weight | Measured with a portable digital infant scale. | Posted | Mean | Standard Deviation | grams | 3 months |
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| Secondary | Infant Weight | Measured with a portable digital infant scale. | Posted | Mean | Standard Deviation | grams | 6 months |
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|
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| Secondary | Infant Weight | Measured with a portable digital infant scale. | Posted | Mean | Standard Deviation | grams | 9 months |
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| Secondary | Infant Weight | Measured with a portable digital infant scale. | Posted | Mean | Standard Deviation | grams | 12 months |
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| Secondary | Infant Weight | Measured with a portable digital infant scale. | Posted | Mean | Standard Deviation | grams | 1 month |
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|
|
| 0 |
| 85 |
| 0 |
| 85 |
| 19 |
| 85 |
| EG001 | 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. | 0 | 83 | 5 | 83 | 26 | 83 |
| Hospitalization of infant | Infections and infestations | Non-systematic Assessment |
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| Infant death | General disorders | Non-systematic Assessment |
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| Homelessness | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Miscarriage | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| COVID infection | Infections and infestations | Non-systematic Assessment |
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| Domestic abuse | Psychiatric disorders | Non-systematic Assessment |
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| ER visit | Infections and infestations | Non-systematic Assessment |
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| Breast cancer or breast issue | Reproductive system and breast disorders | Non-systematic Assessment |
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| Accident | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Family death or separation | Social circumstances | Non-systematic Assessment |
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| Incarceration | Social circumstances | Non-systematic Assessment |
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