Community Interventions to Improve Breastfeeding

NCT05503069 | Completed

• 1 other identifier: Breastfeeding DN00486
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding; Breastfeeding, Exclusive

Keywords

Breastfeeding; African American Mothers

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (2)

Group A - Control

NO INTERVENTION

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

Group B - Intervention

EXPERIMENTAL

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.

Behavioral: Interventions with social and cultural components

Interventions

Interventions with social and cultural components BEHAVIORAL

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.

Group B - Intervention

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Women
• Perinatal complication
• Medical indication to withhold breastfeeding practices Infants
• Prematurity
• Medical indication to withhold breastfeeding
• Congenital condition/malformation

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center-Nursery Department of Pediatrics

Jackson, Mississippi, 39216, United States

Location

Related Publications (7)

• 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.

  PMID: 29435577 BACKGROUND

• 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.

  PMID: 29358479 BACKGROUND

• 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.

  PMID: 28826414 BACKGROUND

• 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.

  PMID: 28879172 BACKGROUND

• 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.

  PMID: 29958205 BACKGROUND

• 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.

  PMID: 29156144 BACKGROUND

• 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.

  PMID: 11787675 BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Interventions

Methods

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Norma B Ojeda, MD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair DABE

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 16, 2022
• Study Start: September 23, 2022
• Primary Completion: December 31, 2025
• Study Completion: February 25, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)