Clinical trial NCT05503069: Community Interventions to Improve Breastfeeding
Official title: Community Interventions to Improve Breastfeeding Rate in African American Mothers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breastfeeding
Breastfeeding, Exclusive
Keywords: Breastfeeding
African American Mothers
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 120
Sex: ALL
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Outcomes in Mothers at 3 months
timeFrame: At 3 months post enrollment.
measure: Outcomes in Mothers at 6 months
timeFrame: At 6 months post enrollment.
measure: Outcomes in Mothers at 12 months
timeFrame: At 12 months post enrollment.
measure: Outcomes in Mothers Perceptions on Support at 12 months
timeFrame: At 12 months post enrollment.
measure: Outcomes in Mothers Perceptions on Infant's wellbeing at 12 months
timeFrame: At 12 months post enrollment.
measure: Outcomes in Infant's development at 3 months
timeFrame: At 3 months post natal
measure: Outcomes in Infant's development at 6 months
timeFrame: At 6 months post natal
measure: Outcomes in Infant's development at 12 months
timeFrame: At 12 months post natal
measure: Outcomes in Infant's health at 3 months
timeFrame: At 3 months post natal
measure: Outcomes in Infant's health at 6 months
timeFrame: At 6 months post natal
measure: Outcomes in Infant's health at 12 months
timeFrame: At 12 months post natal
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center-Nursery Department of Pediatrics
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Norma B Ojeda, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.