Community Interventions to Improve Breastfeeding

Breastfeeding Clinical Trial

Official title:

Community Interventions to Improve Breastfeeding Rate in African American Mothers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05503069
• Other study ID #: Breastfeeding DN00486
• Status: Recruiting
• Phase: N/A
• Start date: September 23, 2022
• Est. completion date: February 25, 2024

Study information

• Verified date: May 2023
• Source: University of Mississippi Medical Center
• Contact: Norma B Ojeda, MD
• Phone: 601-984-1668
• Email: nojeda[@]umc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 25, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding
• Breastfeeding, Exclusive

Intervention

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.

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center-Nursery Department of Pediatrics	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View Citation

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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