Clinical trial NCT03964454: BOOST: Breastfeeding Onset and Onward With Support Tools
Official title: Individual Breastfeeding Support With Contingent Incentives for Low-Income Mothers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breastfeeding Duration
Keywords: Breastfeeding duration
WIC
low-income
health incentives
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Temple University
name: Christiana Care Health Services
First posted: 2019-05-28
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Breastfeeding Their Infants at 1 Month
timeFrame: 1 month
measure: Number of Participants Breastfeeding Their Infants at 3 Months
timeFrame: 3 months
measure: Number of Participants Breastfeeding Their Infants at 6 Months
timeFrame: 6 months
measure: Number of Participants Breastfeeding Their Infants at 9 Months
timeFrame: 9 months
measure: Number of Participants Breastfeeding Their Infants at 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Infant Weight
timeFrame: 3 months
measure: Infant Weight
timeFrame: 6 months
measure: Infant Weight
timeFrame: 9 months
measure: Infant Weight
timeFrame: 12 months
measure: Infant Weight
timeFrame: 1 month
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health Services, Inc.
state: Delaware
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: RTI International
name: Yukiko Washio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.