Enhanced Breastfeeding Support for Increasing Duration

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

168 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI) for increasing breastfeeding duration?

Research shows that adding financial incentives to existing breastfeeding support can help sustain breastfeeding among low-income mothers, as seen in studies with the WIC program. These incentives, combined with education and peer support, have shown promising results in increasing breastfeeding rates. ^{1 2 3 4 5}

Is the Enhanced Breastfeeding Support treatment safe for humans?

The research articles focus on breastfeeding outcomes and policy changes related to the WIC program, but they do not provide specific safety data for the Enhanced Breastfeeding Support treatment. ^{1 5 6 7 8}

How is the Enhanced Breastfeeding Support treatment different from other breastfeeding support options?

This treatment is unique because it combines WIC support with home-based individual support and offers incentives for breastfeeding, which has shown promising effects in sustaining breastfeeding among low-income mothers, unlike traditional support methods that often fall short. ^{1 3 4 5 9}

What is the purpose of this trial?

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.

Research Team

Yukiko Washio, PhD

Principal Investigator

RTI International

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Breastfeeding Duration Is Associated With WIC Site-Level Breastfeeding Support Practices. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

WIC (The Special Supplemental Nutrition Program for Women, Infants, and Children): policy versus practice regarding breastfeeding. [2021]

3. England pubmed.ncbi.nlm.nih.gov

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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Incentive-based Intervention to Maintain Breastfeeding Among Low-income Puerto Rican Mothers. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Impact of policy changes on infant feeding decisions among low-income women participating in the Special Supplemental Nutrition Program for Women, Infants, and Children. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

The new food package and breastfeeding outcomes among women, infants, and children participants in Los Angeles County. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Unintended consequences of the WIC formula rebate program on infant feeding outcomes: will the new food packages be enough? [2012]

8. United States pubmed.ncbi.nlm.nih.gov

The timing and predictors of the early termination of breastfeeding. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Breastfeeding Outcomes Associated With the Special Supplemental Nutrition Program for Women, Infants, and Children: A Systematic Review. [2023]