BreastfeedingBFSNCT01272661
Breast for Success: A Family-Centered Intervention in Support of Breastfeeding Among High-risk Low-income Mothers
A study testing Enhanced Curriculum, Enhanced Curriculum+Breastfeeding Doula and Enhanced Curriculum +Father Support in people with Breastfeeding, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
Breast for Success is a new direct service program focused on overcoming barriers to breastfeeding for low-income inner-city mothers by use of a culturally competent and home-based educational and support intervention. Read more about this study
- Who is it for?
- Ages 14 years and older, women only
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Enhanced Curriculum, Enhanced Curriculum+Breastfeeding Doula and Enhanced Curriculum +Father Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,296 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Nov 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- pregnant woman enrolled in MomsFirst Program of Greater Cleveland
Who cannot join
- incarceration
- Other study populations include the Community Health Workers, the doulas and the fathers of the study mothers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Breast for Success: A Family-Centered Intervention in Support of Breastfeeding Among High-risk Low-income Mothers in Cleveland
Breast for Success is a new direct service program focused on overcoming barriers to breastfeeding for low-income inner-city mothers by use of a culturally competent and home-based educational and support intervention. Key project components include a new Enhanced Breastfeeding Curriculum with brief engaging health literacy focused modules, and two innovative support plans, the Breastfeeding Doula and Father Support Programs. The objective is to increase breastfeeding rates for high-risk inner-city mothers.
Research Questions to evaluate project feasibility and effectiveness are:
- Were all aspects of the Curriculum and Doula and Father Support Programs implemented?
- Is there an increase in the rate of any breastfeeding at 1 month postpartum for all mothers?
- Is there a difference in the rate of any breastfeeding at 1 month postpartum between interventions (Curriculum only, Curriculum+Doula Support, Curriculum+Father Support)?
- What are exclusive breastfeeding rates at 1, 3 and 6 months for all mothers?
Read the detailed description
Low rates of breastfeeding among low-income inner-city mothers represent a challenging health disparity that adversely impacts child and maternal health. The overall objective of Breast for Success is to increase the rates of breastfeeding initiation, continuation and exclusivity among high-risk mothers in the City of Cleveland via home-based culturally appropriate interventions. Key project components include a new Curriculum with brief engaging modules utilizing games, teach-reteach strategies, and interactive learning to address specific barriers identified in focus groups (e.g. pain, low milk supply, breast "myths"), and two innovative support components, the Breastfeeding Doula and Father Support Programs. Breast for Success was developed in collaboration with and will be disseminated in partnership with the Cleveland Department of Public Health MomsFirst initiative (a Healthy Start Program), which delivers comprehensive services including twice-monthly Community Health Worker home visits prenatally through 2 years postpartum to 500 women annually. The investigators will measure program success via participation logs, satisfaction questionnaires and breastfeeding rates at 1, 3 and 6 months postpartum.
- Conditions
- Breastfeeding
- Being tested
- Enhanced Curriculum, Enhanced Curriculum+Breastfeeding Doula, Enhanced Curriculum +Father Support
- Keywords
- breastfeeding, low-income, high-risk, African-American, health disparity
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced CurriculumBehavioural
Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers
Enhanced Curriculum+Breastfeeding DoulaBehavioural
In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum.
Enhanced Curriculum +Father SupportBehavioural
In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Curriculum | Active comparator | New Enhanced Breastfeeding Curriculum with 11 brief modules Receives: Behavioral: Enhanced Curriculum |
| Enhanced Curriculum+Breastfeeding Doula | Active comparator | Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum ("breastfeeding doula") Receives: Behavioral: Enhanced Curriculum+Breastfeeding Doula |
| Enhanced Curriculum +Father Support | Active comparator | Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers Receives: Behavioral: Enhanced Curriculum +Father Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program Feasibility- Feeding Outcome Collected
Measure program feasibility by number of participants who were exposed to the intervention for whom there is any feeding outcome
Measured: by 24 months
Program Feasibility - Curriculum Modules
Measure program feasibility by counting the number of Breastfeeding Curricular modules that were presented of total possible = 11
Measured: by 24 months from program start
Secondary outcomes (4)
Breastfeeding Rate
Measure rate of any breastfeeding (breastfeeding initiation) in the hospital. We will also compare this rate between the 3 intervention groups.
Measured: Any breastfeeding: participants were followed for the duration of hospital stay, an average of 48 hours
Breastfeeding Rate at One Month Postpartum
Measure rate of breastfeeding (rate of any breastfeeding is main measure, also measure rate of exclusive breastfeeding) at one month postpartum. Will compare rate of any breastfeeding one month postpartum to historical data, and will compare rates of any breastfeeding at one month postpartum between intervention groups.
Measured: Any and exclusive breastfeeding at one month, between 21-38 days postpartum
Breastfeeding Rate at 3 Months Postpartum
Measure rates of any and exclusive breastfeeding at 3 months postpartum. Rate of any breastfeeding is presented.
Measured: Any and exclusive breastfeeding at 3 months, between 10-14 weeks postpartum
Breastfeeding Rate at 6 Months Postpartum
Measure breastfeeding rate (any and exclusive) at 6 months postpartum. Rate of any breastfeeding is presented.
Measured: Any and exclusive breastfeeding at 6 months, between 22-26 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,296 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Pediatrics, Mt. Sinai Health Care Foundation
- Responsible party
- Principal investigator, Lydia Furman, University Hospitals Cleveland Medical Center
- Investigators
- Lydia M Furman, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272661
- Sponsor's protocol ID
- BFS-1
- Acronym
- BFS
- Status last verified
- Dec 2014
- First submitted
- 27 Dec 2010
- Last updated
- 5 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast for Success: A Family-Centered Intervention in Support of Breastfeeding Among High-risk Low-income Mothers in Cleveland
- ClinicalTrials.gov ID
- NCT01272661
- Acronym / sponsor ID
- BFS / BFS-1
- Conditions
- Breastfeeding
- Keywords
- breastfeeding, low-income, high-risk, African-American, health disparity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,296 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- American Academy of Pediatrics, Mt. Sinai Health Care Foundation
- Study start
- Jun 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 10 Jan 2011 (estimated)
- Results
- Posted 28 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast for Success is a new direct service program focused on overcoming barriers to breastfeeding for low-income inner-city mothers by use of a culturally competent and home-based educational and support intervention. Key project components include a new Enhanced Breastfeeding Curriculum with brief engaging health literacy focused modules, and two innovative support plans, the Breastfeeding Doula and Father Support Programs. The objective is to increase breastfeeding rates for high-risk inner-city mothers.
Research Questions to evaluate project feasibility and effectiveness are:
- Were all aspects of the Curriculum and Doula and Father Support Programs implemented?
- Is there an increase in the rate of any breastfeeding at 1 month postpartum for all mothers?
- Is there a difference in the rate of any breastfeeding at 1 month postpartum between interventions (Curriculum only, Curriculum+Doula Support, Curriculum+Father Support)?
- What are exclusive breastfeeding rates at 1, 3 and 6 months for all mothers?
Detailed description
Low rates of breastfeeding among low-income inner-city mothers represent a challenging health disparity that adversely impacts child and maternal health. The overall objective of Breast for Success is to increase the rates of breastfeeding initiation, continuation and exclusivity among high-risk mothers in the City of Cleveland via home-based culturally appropriate interventions. Key project components include a new Curriculum with brief engaging modules utilizing games, teach-reteach strategies, and interactive learning to address specific barriers identified in focus groups (e.g. pain, low milk supply, breast "myths"), and two innovative support components, the Breastfeeding Doula and Father Support Programs. Breast for Success was developed in collaboration with and will be disseminated in partnership with the Cleveland Department of Public Health MomsFirst initiative (a Healthy Start Program), which delivers comprehensive services including twice-monthly Community Health Worker home visits prenatally through 2 years postpartum to 500 women annually. The investigators will measure program success via participation logs, satisfaction questionnaires and breastfeeding rates at 1, 3 and 6 months postpartum.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enhanced Curriculum | Active comparator | Behavioral: Enhanced CurriculumNew Enhanced Breastfeeding Curriculum with 11 brief modules |
| Enhanced Curriculum+Breastfeeding Doula | Active comparator | Behavioral: Enhanced Curriculum+Breastfeeding DoulaEnhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum ("breastfeeding doula") |
| Enhanced Curriculum +Father Support | Active comparator | Behavioral: Enhanced Curriculum +Father SupportEnhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- pregnant woman enrolled in MomsFirst Program of Greater Cleveland
Key exclusion criteria (2 listed)
- incarceration
- Other study populations include the Community Health Workers, the doulas and the fathers of the study mothers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced CurriculumBrief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers | Behavioural | Enhanced Curriculum |
| Enhanced Curriculum+Breastfeeding DoulaIn the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum. | Behavioural | Enhanced Curriculum+Breastfeeding Doula |
| Enhanced Curriculum +Father SupportIn the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services. | Behavioural | Enhanced Curriculum +Father Support |
Primary outcome
Program Feasibility- Feeding Outcome Collected
Time frame: by 24 months
Measure program feasibility by number of participants who were exposed to the intervention for whom there is any feeding outcome
Program Feasibility - Curriculum Modules
Time frame: by 24 months from program start
Measure program feasibility by counting the number of Breastfeeding Curricular modules that were presented of total possible = 11
4 secondary outcomes
Breastfeeding Rate
Time frame: Any breastfeeding: participants were followed for the duration of hospital stay, an average of 48 hours
Breastfeeding Rate at One Month Postpartum
Time frame: Any and exclusive breastfeeding at one month, between 21-38 days postpartum
Breastfeeding Rate at 3 Months Postpartum
Time frame: Any and exclusive breastfeeding at 3 months, between 10-14 weeks postpartum
Breastfeeding Rate at 6 Months Postpartum
Time frame: Any and exclusive breastfeeding at 6 months, between 22-26 weeks postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Breastfeeding
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Lactation, Inflammatory Bowel Disease
Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
RecruitingPhase 4
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Psoriasis, Colitis, Ulcerative
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lydia M Furman, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Curriculum, Enhanced Curriculum+Breastfeeding Doula and Enhanced Curriculum +Father Support in people with Breastfeeding, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program Feasibility- Feeding Outcome Collected (time frame: by 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2015.