BOOST: Breastfeeding Onset and Onward With Support Tools

NCT03964454 | Completed Results DMC

• 2 other identifiers: BOOSTR01HD094877
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 2

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.

Conditions

Breastfeeding Duration

Keywords

Breastfeeding duration; WIC; low-income; health incentives

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (5)

• Infant Weight

  3 months

• Infant Weight

  6 months

• Infant Weight

  9 months

• Infant Weight

  12 months

• Infant Weight

  1 month

Study Arms (2)

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.

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

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.

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

Interventions

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.

SC + BFI

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.

SC

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Christiana Care Health Services, Inc.

Newark, Delaware, 19718, United States

Location

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

Related Publications (1)

• 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.

  PMID: 32554737 DERIVED

Results Point of Contact

• Title: Yukiko Washio
• Organization: RTI International

ywashio@rti.org

9194852794

Study Officials

• Yukiko Washio, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Those who are providing home visitations on a monthly basis will be blinded to which condition a participant gets randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 28, 2019
• Study Start: June 19, 2019
• Primary Completion: April 18, 2023
• Study Completion: May 31, 2025
• Last Updated: July 4, 2025
• Results First Posted: January 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be made available after the publication of the study results.
• Access Criteria: 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.

Locations

US (2)