Community Interventions to Improve Breastfeeding

Community Interventions to Improve Breastfeeding Rate in African American Mothers

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.

Study Overview

• Status: Completed
• Conditions: Breastfeeding; Breastfeeding, Exclusive
• Intervention / Treatment: Behavioral: Interventions with social and cultural components

Detailed Description

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

1. Providing a breast milk pumping machine to the mother,
2. Facilitating training session to improve dietary literacy for lactating mothers,
3. 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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center-Nursery Department of Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group A - Control; The control group will receive standard of care, which include basic training by lactation educators.
Experimental: Group B - Intervention; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Mississippi Medical Center
• Investigators: Principal Investigator: Norma B Ojeda, MD, University of Mississippi Medical Center

Publications and helpful links

General Publications

• O'Hare C, Kuh D, Hardy R. Association of Early-Life Factors With Life-Course Trajectories of Resting Heart Rate: More Than 6 Decades of Follow-up. JAMA Pediatr. 2018 Apr 2;172(4):e175525. doi: 10.1001/jamapediatrics.2017.5525. Epub 2018 Apr 2.
• Schwarzenberg SJ, Georgieff MK; COMMITTEE ON NUTRITION. Advocacy for Improving Nutrition in the First 1000 Days to Support Childhood Development and Adult Health. Pediatrics. 2018 Feb;141(2):e20173716. doi: 10.1542/peds.2017-3716. Epub 2018 Jan 22.
• Rantalainen V, Lahti J, Henriksson M, Kajantie E, Mikkonen M, Eriksson JG, Raikkonen K. Association between breastfeeding and better preserved cognitive ability in an elderly cohort of Finnish men. Psychol Med. 2018 Apr;48(6):939-951. doi: 10.1017/S0033291717002331. Epub 2017 Aug 22.
• Indrio F, Martini S, Francavilla R, Corvaglia L, Cristofori F, Mastrolia SA, Neu J, Rautava S, Russo Spena G, Raimondi F, Loverro G. Epigenetic Matters: The Link between Early Nutrition, Microbiome, and Long-term Health Development. Front Pediatr. 2017 Aug 22;5:178. doi: 10.3389/fped.2017.00178. eCollection 2017.
• Alakaam A, Lemacks J, Yadrick K, Connell C, Choi HW, Newman RG. Maternity Nurses' Knowledge and Practice of Breastfeeding in Mississippi. MCN Am J Matern Child Nurs. 2018 Jul/Aug;43(4):225-230. doi: 10.1097/NMC.0000000000000437.
• Alakaam A, Lemacks J, Yadrick K, Connell C, Choi HW, Newman RG. Breastfeeding Practices and Barriers to Implementing the Ten Steps to Successful Breastfeeding in Mississippi Hospitals. J Hum Lact. 2018 May;34(2):322-330. doi: 10.1177/0890334417737294. Epub 2017 Nov 20.
• Agostoni C, Marangoni F, Giovannini M, Galli C, Riva E. Prolonged breast-feeding (six months or more) and milk fat content at six months are associated with higher developmental scores at one year of age within a breast-fed population. Adv Exp Med Biol. 2001;501:137-41. doi: 10.1007/978-1-4615-1371-1_17.

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2022
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): February 25, 2026

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Breastfeeding; African American Mothers
• Additional Relevant MeSH Terms: Behavior; Feeding Behavior; Breast Feeding; Investigative Techniques; Methods
• Other Study ID Numbers: Breastfeeding DN00486

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This study is not including a plan to share IPD with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No