Community Interventions for Breastfeeding

Overseen By Norma B Ojeda, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Mississippi Medical Center

Disqualifiers: Perinatal complication, Prematurity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to support new mothers, particularly from minority communities in Mississippi, in continuing to breastfeed their babies. It focuses on community interventions with social and cultural components, including workplace social support and cultural education about breastfeeding benefits. Participants in the experimental group receive resources like a breast milk pump and training to enhance their nutrition knowledge, while the control group receives basic breastfeeding education. This trial suits mothers who have recently had a full-term baby at UMMC and seek more breastfeeding support. As an unphased trial, it offers a unique opportunity for mothers to access valuable breastfeeding resources and support.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on community support for breastfeeding, so it's best to consult with the trial coordinators or your doctor for guidance.

What prior data suggests that these community interventions are safe for promoting breastfeeding?

Research shows that programs like the one in this trial can help more mothers breastfeed. These programs provide breast pumps and educate about breastfeeding benefits. They are generally safe and well-received, with no major problems reported. Supporting breastfeeding through education and a positive environment benefits both mothers and babies by lowering illness risk and promoting healthy growth. Prospective participants can feel assured about the safety of these programs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for breastfeeding because they incorporate social and cultural elements that go beyond the standard care of basic lactation education. Unlike typical treatments, which focus solely on educating mothers, these interventions provide additional support by offering breast milk pumping machines and enhancing dietary literacy for lactating mothers. They also involve educating family members and caregivers on the benefits of breastfeeding for up to 12 months, which can create a more supportive environment for breastfeeding mothers. This comprehensive approach aims to improve breastfeeding rates and maternal confidence by addressing both practical and social barriers.

What evidence suggests that these community interventions are effective for promoting breastfeeding?

This trial will compare a community intervention with social and cultural components to standard care for breastfeeding support. Research has shown that breastfeeding support programs can significantly increase the number of mothers who continue breastfeeding for up to 6 months. One study found that midwife-led group support sessions helped mothers exclusively breastfeed for 6 months after giving birth. Another review emphasizes the importance of culturally respectful breastfeeding support, particularly for African American women, and shows that it can lead to better breastfeeding outcomes. Overall, these social and cultural support efforts create a positive environment for breastfeeding mothers, which is crucial for encouraging longer breastfeeding periods. ^{1 6 7 8 9}

Who Is on the Research Team?

Norma Ojeda, MD

Principal Investigator

University of Mississippi Medical Center

Are You a Good Fit for This Trial?

This trial is for African American women in Mississippi, aged 25-35, who have recently given birth to a full-term baby. It's aimed at those who can breastfeed and want support to continue doing so. Women with complications or babies with health issues that prevent breastfeeding cannot join.

Inclusion Criteria

I am a woman aged 25-35 who had a full-term, single baby at UMMC after 37 weeks.

My gender does not affect my eligibility.

Exclusion Criteria

Women with perinatal complications or medical indication to withhold breastfeeding practices

Infants born prematurely or with a congenital condition/malformation or medical indication to withhold breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a breast milk pumping machine, dietary literacy training, and educational materials on breastfeeding benefits

12 months

Regular follow-ups and training sessions

Follow-up

Participants are monitored for breastfeeding continuation and infant development at 3, 6, and 12 months

12 months

3 visits (in-person or virtual) at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Interventions with social and cultural components

Trial Overview The study tests community interventions designed to help new mothers keep breastfeeding longer. These include creating supportive work environments for lactating moms and promoting the use of mother's milk in daycare centers, along with educational efforts.

How Is the Trial Designed?

Group I: Group B - Intervention Experimental Treatment 1 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 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.

Group II: Group A - Control Active Control 1 Intervention

The control group will receive standard of care, which include basic training by lactation educators.

Who Is Running the Clinical Trial?

University of Mississippi Medical Center

Lead Sponsor

Trials

185

Recruited

200,000+

Citations

1. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2832390

Interventions to Support Breastfeeding: Updated Evidence ... The updated evidence confirms that breastfeeding support interventions can increase the prevalence of any or exclusive breastfeeding up to and at 6 months.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11013075/

Effectiveness of a Postpartum Breastfeeding Support ... In conclusion, the midwife-led group intervention supporting breastfeeding proved to be effective at maintaining exclusive breastfeeding at 6 months postpartum ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2667268525000294

Effectiveness of interventions to improve breastfeeding ... Effectiveness of interventions to improve breastfeeding outcomes among women from vulnerable ethnic groups: Protocol for a systematic review and meta-analysis.

4. equityhealthj.biomedcentral.com equityhealthj.biomedcentral.com/articles/10.1186/s12939-021-01419-0

Improving support for breastfeeding mothers: a qualitative ... This study aimed to explore mothers' experiences of breastfeeding and accessing breastfeeding services offered locally amongst a deprived and culturally ...

5. journals.lww.com journals.lww.com/jpnnjournal/fulltext/2025/04000/a_narrative_review_of_culturally_informed.10.aspx

A Narrative Review of Culturally Informed Breastfeeding... This narrative review provides evidence on the utility and essence of culturally informed breastfeeding interventions for African American women.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK615496/

Interventions to Support Breastfeeding: Updated Evidence ... The most recent national study examining the relationship between breastfeeding and infant mortality reported a 33 percent reduced risk of early post-perinatal ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12250864/

Developing a Framework for Culturally Sensitive ... The guide assessed participant breastfeeding knowledge, attitudes, feeding practices, breastfeeding barriers, experiences with lactation support ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2590113325000100

An overview of reviews of breastfeeding barriers and ... This overview of reviews aims to synthesize barriers and facilitators of breastfeeding, analyze research trends, and identify gaps to guide future research.

9. uspreventiveservicestaskforce.org uspreventiveservicestaskforce.org/uspstf/recommendation/breastfeeding-primary-care-interventions

Recommendation: Breastfeeding: Primary Care Behavioral ... Behavioral counseling interventions that help increase breastfeeding rates include breastfeeding education and support. Breastfeeding ...