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

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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+