BOOST: Breastfeeding Onset and Onward With Support Tools

Breastfeeding Duration Clinical Trial

Official title:

Individual Breastfeeding Support With Contingent Incentives for Low-Income Mothers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03964454
• Other study ID #: BOOST
• Secondary ID: R01HD094877
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 19, 2019
• Est. completion date: May 31, 2024

Study information

• Verified date: November 2023
• Source: RTI International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 168
• Est. completion date: May 31, 2024
• Est. primary completion date: April 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding Duration

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Christiana Care Health Services, Inc.	Newark	Delaware
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
RTI International	Christiana Care Health Services, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Breastfeeding	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
Primary	Rate of Breastfeeding	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
Primary	Rate of Breastfeeding	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
Primary	Rate of Breastfeeding	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
Primary	Rate of Breastfeeding	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
Primary	Rate of Pumping	For pumping, observed pumping combined with observed resulting milk being fed to the infant.	1 month
Primary	Rate of Pumping	For pumping, observed pumping combined with observed resulting milk being fed to the infant.	3 months
Primary	Rate of Pumping	For pumping, observed pumping combined with observed resulting milk being fed to the infant.	6 months
Primary	Rate of Pumping	For pumping, observed pumping combined with observed resulting milk being fed to the infant.	9 months
Primary	Rate of Pumping	For pumping, observed pumping combined with observed resulting milk being fed to the infant.	12 months
Secondary	Infant weight gain	Measured with a portable digital infant scale. Infant weight will be measured before and after each breastfeeding observation in case of breastfeeding mothers to also measure the breast milk in the stomach	1 month
Secondary	Infant weight gain	Measured with a portable digital infant scale. Infant weight will be measured before and after each breastfeeding observation in case of breastfeeding mothers to also measure the breast milk in the stomach	3 months
Secondary	Infant weight gain	Measured with a portable digital infant scale. Infant weight will be measured before and after each breastfeeding observation in case of breastfeeding mothers to also measure the breast milk in the stomach	6 months
Secondary	Infant weight gain	Measured with a portable digital infant scale. Infant weight will be measured before and after each breastfeeding observation in case of breastfeeding mothers to also measure the breast milk in the stomach	9 months
Secondary	Infant weight gain	Measured with a portable digital infant scale. Infant weight will be measured before and after each breastfeeding observation in case of breastfeeding mothers to also measure the breast milk in the stomach	12 months
Secondary	Number of Emergency room and pediatrician visits	Self-reported and medical records of infant health issues with the numbers and reason of medical visits	1 months
Secondary	Number of Emergency room and pediatrician visits	Self-reported and medical records of infant health issues with the numbers and reason of medical visits	3 months
Secondary	Number of Emergency room and pediatrician visits	Self-reported and medical records of infant health issues with the numbers and reason of medical visits	6 months
Secondary	Number of Emergency room and pediatrician visits	Self-reported and medical records of infant health issues with the numbers and reason of medical visits	9 months
Secondary	Number of Emergency room and pediatrician visits	Self-reported and medical records of infant health issues with the numbers and reason of medical visits	12 months