NCT05377372

Brief Summary

This study is being conducted to determine the relationship between early childhood exposures, such as Adverse Childhood Experiences, Social Determinants of Health and nutrition/breastfeeding, among children with sickle cell disease, and behavioral interventions aimed to reshape psychological resilience and lifestyle factors towards positive health outcomes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Feb 2026Dec 2027

First Submitted

Initial submission to the registry

May 11, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 17, 2022

Completed
3.7 years until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

May 11, 2022

Last Update Submit

February 5, 2026

Conditions

Sickle Cell DiseaseBreastfeedingAdverse Childhood Experiences

Keywords

Sickle cell diseaseAdverse Childhood ExperiencesBreastfeeding

Outcome Measures

Primary Outcomes (2)

  • Acceptance and Retention of Mothers of Infants with Sickle Cell Disease to a Community-based Breastfeeding Intervention

    acceptance (number of mothers enrolled/number of mothers approached) and retention (number of mothers to complete 6 month support group intervention/number enrolled)

    6 months

  • Preliminary Effectiveness

    Percentage of mothers of infants with sickle cell disease that successful complete 6 months of breastfeeding, comparing the intervention vs. control groups

    2 years

Secondary Outcomes (2)

  • Asthma

    4 year follow up period

  • Acute chest syndrome

    4 year follow up period

Study Arms (2)

Breastfeeding Intervention Group

EXPERIMENTAL

Ten mother-infant dyads will be recruited to a six-month, community-based intervention aimed to promote sustained breastfeeding for at least six months among mothers of infants with sickle cell disease. The intervention will include an online, social media-based support group, online educational modules, monthly in-person educational sessions, access to free breast pump rentals, and monthly peer-led home visits by certified Vanderbilt-affiliated Maternal Infant Health Outreach Specialists. We obtain whole blood specimens for analysis of oxidative stress and inflammation at 3, 6, 12 and 24 months.

Behavioral: Breastfeeding support group

Observation Group

OTHER

A 24 month observation of 10 mother-infant dyads affected by sickle cell disease that initiate breastfeeding. These dyads will observed for breastfeeding exclusivity/dosage and duration. We obtain whole blood specimens for analysis of oxidative stress and inflammation at 3, 6, 12 and 24 months.

Other: Observation

Interventions

Breastfeeding support groupBEHAVIORAL

community-based breastfeeding support group aimed to increase exclusive breastfeeding success rates among Black women

Breastfeeding Intervention Group
ObservationOTHER

Observe prospectively for breastfeeding initiation, duration and longitudinal health of child with sickle cell disease

Observation Group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • mother of infant with sickle cell disease
  • resides within the city of Birmingham, Alabama or in close proximity

You may not qualify if:

  • prescribed teratogenic medications
  • no/limited internet access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle CellBreast Feeding

Interventions

Observation

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Brandi M Pernell, DNP, MSPH

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandi M Pernell, DNP, MSPH

CONTACT

2058640238brandimcclain@uabmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 11, 2022

First Posted

May 17, 2022

Study Start

February 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

US(1)