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Completed

NCT Number: NCT03964454

BOOST: Breastfeeding Onset and Onward With Support Tools

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.

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Key information

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Christiana Care Health Services, Inc., Newark, Delaware, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of Participants Breastfeeding Their Infants at 1 Month

    Time frame: 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.

  2. Number of Participants Breastfeeding Their Infants at 3 Months

    Time frame: 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. Number of Participants Breastfeeding Their Infants at 6 Months

    Time frame: 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.

  4. Number of Participants Breastfeeding Their Infants at 9 Months

    Time frame: 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.

  5. Number of Participants Breastfeeding Their Infants at 12 Months

    Time frame: 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.

Secondary outcomes

  1. Infant Weight

    Time frame: 3 months

    Measured with a portable digital infant scale.

  2. Infant Weight

    Time frame: 6 months

    Measured with a portable digital infant scale.

  3. Infant Weight

    Time frame: 9 months

    Measured with a portable digital infant scale.

  4. Infant Weight

    Time frame: 12 months

    Measured with a portable digital infant scale.

  5. Infant Weight

    Time frame: 1 month

    Measured with a portable digital infant scale.

Sponsors and collaborators

Lead sponsor

RTI International

Other

Collaborators

  • Christiana Care Health Services
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Temple University

Registry information

Official study title

Individual Breastfeeding Support With Contingent Incentives for Low-Income Mothers

Important dates

Study start
2019
Primary completion
2023
Study completion
2025
First posted
May 28, 2019
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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