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BOOST: Breastfeeding Onset and Onward With Support Tools

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ClinicalTrials.gov Identifier: NCT03964454
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : February 20, 2020
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Temple University
Christiana Care Health Services
Information provided by (Responsible Party):
RTI International

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.

Condition or disease Intervention/treatment Phase
Breastfeeding Duration Behavioral: WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI) Behavioral: WIC support + home-based individual support (SC) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description: Those who are providing home visitations on a monthly basis will be blinded to which condition a participant gets randomized.
Primary Purpose: Treatment
Official Title: Individual Breastfeeding Support With Contingent Incentives for Low-Income Mothers
Actual Study Start Date : June 19, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
Experimental: 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 contingent on observed breastfeeding.
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.

Active Comparator: SC
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)
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.




Primary Outcome Measures :
  1. Rate of Breastfeeding [ Time Frame: 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.

  2. Rate of Breastfeeding [ Time Frame: 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. Rate of Breastfeeding [ Time Frame: 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.

  4. Rate of Breastfeeding [ Time Frame: 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.

  5. Rate of Breastfeeding [ Time Frame: 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.

  6. Rate of Pumping [ Time Frame: 1 month ]
    For pumping, observed pumping combined with observed resulting milk being fed to the infant.

  7. Rate of Pumping [ Time Frame: 3 months ]
    For pumping, observed pumping combined with observed resulting milk being fed to the infant.

  8. Rate of Pumping [ Time Frame: 6 months ]
    For pumping, observed pumping combined with observed resulting milk being fed to the infant.

  9. Rate of Pumping [ Time Frame: 9 months ]
    For pumping, observed pumping combined with observed resulting milk being fed to the infant.

  10. Rate of Pumping [ Time Frame: 12 months ]
    For pumping, observed pumping combined with observed resulting milk being fed to the infant.


Secondary Outcome Measures :
  1. Infant weight gain [ Time Frame: 1 month ]
    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

  2. Infant weight gain [ Time Frame: 3 months ]
    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. Infant weight gain [ Time Frame: 6 months ]
    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

  4. Infant weight gain [ Time Frame: 9 months ]
    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

  5. Infant weight gain [ Time Frame: 12 months ]
    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. Number of Emergency room and pediatrician visits [ Time Frame: 1 months ]
    Self-reported and medical records of infant health issues with the numbers and reason of medical visits

  7. Number of Emergency room and pediatrician visits [ Time Frame: 3 months ]
    Self-reported and medical records of infant health issues with the numbers and reason of medical visits

  8. Number of Emergency room and pediatrician visits [ Time Frame: 6 months ]
    Self-reported and medical records of infant health issues with the numbers and reason of medical visits

  9. Number of Emergency room and pediatrician visits [ Time Frame: 9 months ]
    Self-reported and medical records of infant health issues with the numbers and reason of medical visits

  10. Number of Emergency room and pediatrician visits [ Time Frame: 12 months ]
    Self-reported and medical records of infant health issues with the numbers and reason of medical visits



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964454


Contacts
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Contact: Yukiko Washio, PhD (919) 485-2794 ywashio@rti.org

Locations
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United States, Delaware
Christiana Care Health Services, Inc. Not yet recruiting
Newark, Delaware, United States, 19718
Contact: Matthew K Hoffman, MPH, MD    302-733-3350    mhoffman@christianacare.org   
Contact: Zugui Zhang, PhD         
Principal Investigator: Matthew K Hoffman, MPH, MD         
Sub-Investigator: Zugui Zhang, PhD         
United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19122
Contact: Bradley N Collins, PhD    215-204-2849    collinsb@temple.edu   
Contact: Gail Herrine, MD         
Principal Investigator: Bradley N Collins, PhD         
Sub-Investigator: Gail Herrine, MD         
Sponsors and Collaborators
RTI International
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Temple University
Christiana Care Health Services
Investigators
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Principal Investigator: Yukiko Washio, PhD RTI International
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: RTI International
ClinicalTrials.gov Identifier: NCT03964454    
Other Study ID Numbers: BOOST
R01HD094877 ( U.S. NIH Grant/Contract )
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A limited data set in which names and other personal health identifiers are removed, as defined by the Health Insurance Portability and Accountability Act (HIPAA), will be supplied to researchers on request.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RTI International:
Breastfeeding duration
WIC
low-income
health incentives