Enhanced Breastfeeding Support for Increasing Duration

No longer recruiting at 1 trial location

Overseen By Yukiko Washio, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: RTI International

Disqualifiers: Illicit drug use, Psychiatric hospitalization, Suicidal thoughts, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding financial incentives to regular breastfeeding support can help low-income mothers breastfeed longer. Participants will receive either the standard breastfeeding services from WIC or the same services plus extra support and financial rewards for breastfeeding, known as SC+BFI. Researchers believe this approach might extend breastfeeding duration, promote healthier babies, and reduce healthcare costs. Mothers who are already breastfeeding and involved with WIC, or eligible to join, may be suitable for this trial if they plan to remain in the study area for a year after giving birth. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance breastfeeding support for many families.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this behavioral intervention is safe for increasing breastfeeding duration?

Research has shown that offering financial incentives alongside breastfeeding support is safe for both mothers and babies. Studies have found that these incentives help mothers continue breastfeeding without harm. The program includes regular WIC support, home visits, and financial rewards for breastfeeding. This method has been well-received and appears to help mothers breastfeed for longer periods. No negative effects have been reported from this approach, so it is considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores an innovative approach to enhancing breastfeeding duration through a combination of support and incentives. Unlike standard care, which typically involves breastfeeding support from programs like WIC, this trial adds a unique twist with home-based individual support and financial incentives for observed breastfeeding. This combination aims to provide tailored guidance and motivation, potentially overcoming common barriers that new mothers face. By integrating these elements, the trial hopes to discover effective strategies for improving breastfeeding rates, offering promising insights for future support programs.

What evidence suggests that this trial's interventions could be effective for increasing breastfeeding duration?

This trial will compare two approaches to breastfeeding support. Participants in one arm will receive WIC support and home-based individual support, while those in the other arm will receive the same support plus financial incentives for breastfeeding. Research has shown that financial rewards, when combined with breastfeeding support, can help mothers breastfeed for a longer time. Studies have found that this method, which combines personal support with rewards, effectively maintains breastfeeding rates. Early results suggest that offering these rewards, along with existing WIC support and home visits, shows promise for extending breastfeeding duration. A detailed review noted that changes in the WIC program have improved breastfeeding outcomes. Overall, combining support with financial rewards is a promising way to help low-income mothers breastfeed longer. ^{1 4 6 7 8}

Who Is on the Research Team?

Yukiko Washio, PhD

Principal Investigator

RTI International

Are You a Good Fit for This Trial?

The BOOST trial is for new mothers who have started breastfeeding, are at least 18 years old, and understand English at a fifth-grade level. They must be enrolled or eligible for WIC services and plan to stay in the study area for one year postpartum.

Inclusion Criteria

Mothers must breastfeed their baby from the beginning.

I have given my consent to participate voluntarily.

mothers must be WIC-enrolled or eligible to enroll in WIC services

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard breastfeeding services from WIC plus monthly home visits, with financial incentives for observed breastfeeding in the SC+BFI group

6 months

Monthly home visits

Follow-up

Participants are monitored for breastfeeding behavior and infant health outcomes

6 months

Monthly assessments

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview This trial tests if adding monthly financial rewards to standard WIC support and home visits can extend how long low-income moms breastfeed. The goal is to see if this approach leads to fewer baby health problems and saves on healthcare costs.

How Is the Trial Designed?

Group I: SC + BFI Experimental Treatment 1 Intervention

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.

Group II: SC Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

RTI International

Lead Sponsor

Trials

201

Recruited

942,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Temple University

Collaborator

Trials

321

Recruited

89,100+

Christiana Care Health Services

Collaborator

Trials

118

Recruited

204,000+

Citations

1. reporter.nih.gov reporter.nih.gov/search/ED9MYH3wzUGIVEg9BmkBTQ/project-details/10404554

Individual Breastfeeding Support with Contingent Incentives for Low ... The primary outcome will be the BF rate for 6-month postpartum, the exploratory outcome will be the BF rate at 12-month postpartum, and the secondary outcomes ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7304794/

Individual breastfeeding support with contingent incentives ... The preliminary outcomes of contingent incentives for breastfeeding in addition to existing support show promising effects in sustaining breastfeeding.

3. withpower.com withpower.com/trial/phase-5-2019-927d6

Enhanced Breastfeeding Support for Increasing Duration This treatment is unique because it combines WIC support with home-based individual support and offers incentives for breastfeeding, which has shown promising ...

4. fns.usda.gov fns.usda.gov/wic/breastfeeding-data

WIC Breastfeeding Data Local Agency Report These reports are a compilation of fiscal year (FY) breastfeeding performance measurements, based on program participation data.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1876285922005344

Systematic Review Breastfeeding Outcomes Associated ... A prior review reported negative associations of WIC with breastfeeding outcomes. WIC food package changes in 2009 increased breastfeeding support. Objective.

6. reporter.nih.gov reporter.nih.gov/search/sGlAo81Rlk-dLUfYwtpQWQ/project-details/9988848

RePORT RePORTER - National Institutes of Health (NIH) | Participants randomized into SC will receive standard breastfeeding services from WIC and home visitations for individual support and problem- solving.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03964454

BOOST: Breastfeeding Onset and Onward With Support ... Results suggested strong potential for efficacy of monthly financial incentives contingent on observed breastfeeding for 6 months combined with WIC usual care, ...

8. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2832390

Interventions to Support Breastfeeding: Updated Evidence ... The updated evidence confirms that breastfeeding support interventions can increase the prevalence of any or exclusive breastfeeding up to and at 6 months.