Community Interventions to Improve Breastfeeding

Study Overview
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Brief Summary
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The percentage of women breastfeeding their newborn babies is very low among minority populations such as African American women in Mississippi. There are good results with initiatives supporting the initiation of breastfeeding after delivery. However, the percentages of continuation of breastfeeding up to 3, 6 or 12 months are still very low in Mississippi. Therefore, this project is proposing to focus on community interventions including social and cultural components to promote and support continuation of breastfeeding. The social component will include interventions to promote supportive environments in the workplace for lactating mothers, as well as promoting the use of mother's milk to feed infants in daycare centers. The cultural component will focus on educating and raising awareness of the benefit of BF to prevent absenteeism at work, to reduce child illnesses, and to promote healthy child development. The cultural component will target the mother with her family and spouse/partner, employers, and daycare managers.

Detailed Description
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The hypothesis of whether community interventions supporting breastfeeding practices will increase the rates of continuing breastfeeding at 6 and 12 months among African American women, will be tested with the following specific aims Aim 1: Will test whether providing breast milk pumping machine to lactating mothers will promote continuation of breastfeeding up to 6 and 12 months. The intervention associated with this aim will include the provision of breast milk pumping machines free of charge to new mothers in the intervention arm at the time of discharge from the hospital. Mothers in the control group will follow standard of care practices, which do not include provision of pumping machines at discharge from the hospital. Aim 2: Will test whether providing training to improve dietary literacy for lactating mothers will improve continuation of breastfeeding up to 6 and 12 months. The intervention associated with this aim will include training session on topic related to dietary practices for lactating mothers. Aim 3: Will test whether providing educational materials describing the benefits breastfeeding to family members, employers, and day care managers will improve continuing breastfeeding up to 6 and 12 months. Study Design This project will utilize a cohort case-controlled study design. There will be two arms with equally enrolled participants in each arm (1:1). Participants will be allocated in the control and intervention arm utilizing simple randomization with fixed number (n=60) for each arm distributed in group A (control) and group B (intervention). The participants will randomly select an envelope concealing the group label after signed the consent form. The participants will open the envelope in front of research coordinator and the allocation group will be revealed. The study will target African American women between 25 and 35 years of age who delivered singleton full term babies at the University of Mississippi Medical Center, without any perinatal complications. Babies of both sexes will be included. The Dyads of mother/infant participants will be randomized in the following groups: A- Control arm with n=60 participants, and B- Intervention arm with n=60 participants. Women in the intervention arm will receive standard of care, which includes basic training in breastfeeding by lactation educators, and the action items related to the intervention. The intervention will include the following Providing a breast milk pumping machine to the mother, Facilitating training session to improve dietary literacy for lactating mothers, Distribution of educational material describing the benefits of continuing breastfeeding infants up to 12 months of age to family members, employers, day care managers/caregivers. The control group will receive standard of care, which include basic training by lactation educators.

Official Title
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Community Interventions to Improve Breastfeeding Rate in African American Mothers

Conditions
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Breastfeeding, Breastfeeding, Exclusive

Intervention / Treatment
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* Behavioral: Interventions with social and cultural components


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women Age: 25 to 35 years of age Delivery: Full-term, singleton delivery at UMMC Infants Gestational Age: ≥ 37 weeks of gestation Sex: Both sexes Exclusion Criteria: Women Perinatal complication Medical indication to withhold breastfeeding practices Infants Prematurity Medical indication to withhold breastfeeding Congenital condition/malformation

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This project will utilize a cohort case-controlled study design. There will be two arms with equally enrolled participants in each arm (1:1). Participants will be allocated in the control and intervention arm utilizing simple randomization with fixed number (n=60) for each arm distributed in group A (control) and group B (intervention). The participants will randomly select an envelope concealing the group label after signed the consent form.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group A - Control<br>The control group will receive standard of care, which include basic training by lactation educators. | |
| Experimental: Group B - Intervention<br>Women in the intervention arm will receive standard of care, which includes basic training in breastfeeding by lactation educators, and the action items related to the intervention. The intervention will include the following Providing a breast milk pumping machine to the mother, Facilitating training session to improve dietary literacy for lactating mothers, Distribution of educational material describing the benefits of continuing breastfeeding infants up to 12 months of age to family members, employers, day care managers/caregivers. | Behavioral: Interventions with social and cultural components<br>* Intervention Components Enrollment: We are expecting an enrollment rate of 20 participants per week, and completing enrollment in 6 weeks (n=120 participants) Baseline Data Collection Distribution of Educational Materials Lactation Training Dietary Literacy Training Follow Up Data collection: Infant's information on growth and development and Medical History of Infections, GI problems (diarrhea, constipation, colic, vomits, reflux) will be collected at 3, 6 and 12 months. Follow UP Surveys: Mothers will complete a short survey at 3, 6, and 12 months exploring their breastfeeding behaviors and challenges. Exit survey: Mothers will be asked to complete an exit survey on month 12 post-enrollment to explore their perception on the participation in the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcomes in Mothers at 3 months | -Rates of continuation of breastfeeding at 3 months will be collected during the short phone interview. | At 3 months post enrollment. | 
| Outcomes in Mothers at 6 months | -Rates of continuation of breastfeeding at 6 months will be collected during the short phone interview. | At 6 months post enrollment. | 
| Outcomes in Mothers at 12 months | -Rates of continuation of breastfeeding at 12 months will be collected during the short phone interview. | At 12 months post enrollment. | 
| Outcomes in Mothers Perceptions on Support at 12 months | -Perception of mother on community support to promote breastfeeding will be explored with the exit survey. | At 12 months post enrollment. | 
| Outcomes in Mothers Perceptions on Infant's wellbeing at 12 months | -Perception of mother on infant wellbeing associated with breastfeeding practices will explored with exit survey. | At 12 months post enrollment. | 
| Outcomes in Infant's development at 3 months | Development and growth using the percentile in growth chart will be collected at 3 months of age. | At 3 months post natal | 
| Outcomes in Infant's development at 6 months | Development and growth using the percentile in growth chart will be collected at 6 months of age. | At 6 months post natal | 
| Outcomes in Infant's development at 12 months | Development and growth using the percentile in growth chart will be collected at 12 months of age. | At 12 months post natal | 
| Outcomes in Infant's health at 3 months | -Incidence of infections and gastrointestinal problems will be collected at 3 months of age. | At 3 months post natal | 
| Outcomes in Infant's health at 6 months | -Incidence of infections and gastrointestinal problems will be collected at 6 months of age. | At 6 months post natal | 
| Outcomes in Infant's health at 12 months | -Incidence of infections and gastrointestinal problems will be collected at 12 months of age. | At 12 months post natal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breastfeeding, African American Mothers