Breastfeeding
Conditions
Keywords
breastfeeding, low-income, high-risk, African-American, health disparity
Brief 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. 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: 1. Were all aspects of the Curriculum and Doula and Father Support Programs implemented? 2. Is there an increase in the rate of any breastfeeding at 1 month postpartum for all mothers? 3. Is there a difference in the rate of any breastfeeding at 1 month postpartum between interventions (Curriculum only, Curriculum+Doula Support, Curriculum+Father Support)? 4. 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.
Interventions
BEHAVIORALEnhanced Curriculum
Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers
BEHAVIORALEnhanced Curriculum+Breastfeeding Doula
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.
BEHAVIORALEnhanced Curriculum +Father Support
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.
Sponsors
American Academy of Pediatrics
Mt. Sinai Health Care Foundation
University Hospitals Cleveland Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* pregnant woman enrolled in MomsFirst Program of Greater Cleveland
Exclusion criteria
* incarceration Other study populations include the Community Health Workers, the doulas and the fathers of the study mothers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Program Feasibility- Feeding Outcome Collected | 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 | by 24 months from program start | Measure program feasibility by counting the number of Breastfeeding Curricular modules that were presented of total possible = 11 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breastfeeding Rate | Any breastfeeding: participants were followed for the duration of hospital stay, an average of 48 hours | Measure rate of any breastfeeding (breastfeeding initiation) in the hospital. We will also compare this rate between the 3 intervention groups. |
| Breastfeeding Rate at One Month Postpartum | Any and exclusive breastfeeding at one month, between 21-38 days 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. |
| Breastfeeding Rate at 3 Months Postpartum | Any and exclusive breastfeeding at 3 months, between 10-14 weeks postpartum | Measure rates of any and exclusive breastfeeding at 3 months postpartum. Rate of any breastfeeding is presented. |
| Breastfeeding Rate at 6 Months Postpartum | Any and exclusive breastfeeding at 6 months, between 22-26 weeks postpartum | Measure breastfeeding rate (any and exclusive) at 6 months postpartum. Rate of any breastfeeding is presented. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enhanced Curriculum New Enhanced Breastfeeding Curriculum with 11 brief modules
Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers | 413 |
| Enhanced Curriculum+Breastfeeding Doula Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)
Enhanced Curriculum+Breastfeeding Doula: 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. | 497 |
| Enhanced Curriculum+Father Support Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers
Enhanced Curriculum+Father Support Program: 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. | 386 |
| Total | 1,296 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | lost to followup/case closed/ no birth | 126 | 209 | 72 |
Baseline characteristics
| Characteristic | Enhanced Curriculum | Enhanced Curriculum+Breastfeeding Doula | Enhanced Curriculum+Father Support | Total |
|---|---|---|---|---|
| Age, Continuous | 21.2 years STANDARD_DEVIATION 4.8 | 22.2 years STANDARD_DEVIATION 4.4 | 23.1 years STANDARD_DEVIATION 4.9 | 22.2 years STANDARD_DEVIATION 4.9 |
| Region of Enrollment United States | 413 participants | 497 participants | 386 participants | 1296 participants |
| Sex: Female, Male Female | 413 Participants | 497 Participants | 386 Participants | 1296 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 413 | 0 / 497 | 0 / 386 |
| serious Total, serious adverse events | 0 / 413 | 0 / 497 | 0 / 386 |
Outcome results
Primary
Program Feasibility - Curriculum Modules
Measure program feasibility by counting the number of Breastfeeding Curricular modules that were presented of total possible = 11
Time frame: by 24 months from program start
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enhanced Curriculum | Program Feasibility - Curriculum Modules | 4 modules presented |
| Enhanced Curriculum+Breastfeeding Doula | Program Feasibility - Curriculum Modules | 3 modules presented |
| Enhanced Curriculum+Father Support Program | Program Feasibility - Curriculum Modules | 2 modules presented |
Primary
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
Time frame: by 24 months
Population: Total number of eligible MomsFirst participants who agreed to data sharing. Outcome shows number w/ any feeding outcome (not lost to follow up, no live birth, case closed by MomsFirst). This is for a 24 month period since all data was de-identified and stripped of dates so unable to specify for 12 month period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Curriculum | Program Feasibility- Feeding Outcome Collected | 287 participants |
| Enhanced Curriculum+Breastfeeding Doula | Program Feasibility- Feeding Outcome Collected | 288 participants |
| Enhanced Curriculum+Father Support Program | Program Feasibility- Feeding Outcome Collected | 314 participants |
Secondary
Breastfeeding Rate
Measure rate of any breastfeeding (breastfeeding initiation) in the hospital. We will also compare this rate between the 3 intervention groups.
Time frame: Any breastfeeding: participants were followed for the duration of hospital stay, an average of 48 hours
Population: ITT analysis was conducted on participants with available data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Curriculum | Breastfeeding Rate | 66 participants |
| Enhanced Curriculum+Breastfeeding Doula | Breastfeeding Rate | 98 participants |
| Enhanced Curriculum+Father Support Program | Breastfeeding Rate | 152 participants |
Secondary
Breastfeeding Rate at 3 Months Postpartum
Measure rates of any and exclusive breastfeeding at 3 months postpartum. Rate of any breastfeeding is presented.
Time frame: Any and exclusive breastfeeding at 3 months, between 10-14 weeks postpartum
Population: ITT analysis conducted on participants with available data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Curriculum | Breastfeeding Rate at 3 Months Postpartum | 48 participants |
| Enhanced Curriculum+Breastfeeding Doula | Breastfeeding Rate at 3 Months Postpartum | 44 participants |
| Enhanced Curriculum+Father Support Program | Breastfeeding Rate at 3 Months Postpartum | 67 participants |
Secondary
Breastfeeding Rate at 6 Months Postpartum
Measure breastfeeding rate (any and exclusive) at 6 months postpartum. Rate of any breastfeeding is presented.
Time frame: Any and exclusive breastfeeding at 6 months, between 22-26 weeks postpartum
Population: ITT analysis conducted on participants with available data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Curriculum | Breastfeeding Rate at 6 Months Postpartum | 22 participants |
| Enhanced Curriculum+Breastfeeding Doula | Breastfeeding Rate at 6 Months Postpartum | 18 participants |
| Enhanced Curriculum+Father Support Program | Breastfeeding Rate at 6 Months Postpartum | 38 participants |
Secondary
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.
Time frame: Any and exclusive breastfeeding at one month, between 21-38 days postpartum
Population: ITT analysis conducted on participants with available data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Curriculum | Breastfeeding Rate at One Month Postpartum | 100 participants |
| Enhanced Curriculum+Breastfeeding Doula | Breastfeeding Rate at One Month Postpartum | 95 participants |
| Enhanced Curriculum+Father Support Program | Breastfeeding Rate at One Month Postpartum | 134 participants |