- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03964454
BOOST: Breastfeeding Onset and Onward With Support Tools
Individual Breastfeeding Support With Contingent Incentives for Low-Income Mothers
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Delaware
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Newark, Delaware, United States, 19718
- Christiana Care Health Services, Inc.
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19122
- Temple University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 month
|
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 months
|
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.
|
6 months
|
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.
|
9 months
|
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.
|
12 months
|
Rate of Pumping
Time Frame: 1 month
|
For pumping, observed pumping combined with observed resulting milk being fed to the infant.
|
1 month
|
Rate of Pumping
Time Frame: 3 months
|
For pumping, observed pumping combined with observed resulting milk being fed to the infant.
|
3 months
|
Rate of Pumping
Time Frame: 6 months
|
For pumping, observed pumping combined with observed resulting milk being fed to the infant.
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6 months
|
Rate of Pumping
Time Frame: 9 months
|
For pumping, observed pumping combined with observed resulting milk being fed to the infant.
|
9 months
|
Rate of Pumping
Time Frame: 12 months
|
For pumping, observed pumping combined with observed resulting milk being fed to the infant.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 month
|
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 months
|
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
|
6 months
|
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
|
9 months
|
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
|
12 months
|
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
|
1 months
|
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
|
3 months
|
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
|
6 months
|
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
|
9 months
|
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
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yukiko Washio, PhD, RTI International
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BOOST
- R01HD094877 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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