Recruiting

MIACT

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT07932652

Conditions

Mothers' Own Milk Feeding

Cessation or Non-initiation of Mothers' Own Milk Feeding

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT) (MIACT)

Usual Lactation Support

Study Details

Brief summary:

The purpose of this study is to adapt, refine, and test the feasibility, acceptability, and implementation of a novel Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT) (MIACT) intervention delivered by lactation specialists to increase Black mothers' own milk (MOM) feeding with their infants and to pilot test the efficacy of the MIACT intervention in a sample of Black mothers and their infants to increase MOM-feeding initiation and duration and improve secondary infant and maternal outcomes (e.g., infant length-of-stay, maternal stress), compared to usual lactation support in a neonatal intensive care unit (NICU). The goals of MIACT are to increase mothers' psychological flexibility and motivation for MOM feeding by increasing acceptance and willingness to experience ambivalent and/or uncomfortable thoughts, feelings, and physical sensations related to MOM feeding, with particular attention to the unique needs of Black mothers. Concerns, views, and feelings around MOM feeding will be identified, followed by discussion and practice of acceptance and mindfulness skills. Maternal values will be elicited and goals based on personal values will be set.

Conditions

Mothers' Own Milk Feeding

Cessation or Non-initiation of Mothers' Own Milk Feeding

Study ID

NCT07932652

Start date

Oct 15, 2026

Status verified date

Nov, 2026

Completion date

Jun 15, 2028

Anticipated

Primary completion date

Mar 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • mother identifies as Black
  • speaks, reads, and writes English
  • able to provide MOM
  • has a NICU-admitted infant able to receive MOM

Exclusion Criteria:

  • A medical (e.g., maternal HIV+, infant galactosemia) or physical condition (e.g., total mastectomy) preventing MOM feeding (e.g., to avoid HIV transmission)
  • infants placed in adoptive care, precluding follow-up
  • an infant life-limiting condition (e.g., Trisomy 13, 18)

Study Design

Enrollment

1176 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT) (MIACT) Lactation Support

active comparator: Usual Lactation Support

Interventions

Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT) (MIACT)

MIACT interventions will occur within conventional lactation visits, during which specialists often guide, observe, and troubleshoot with mothers. The lactation service consults mothers in <24 hours, again <48 hours, and at 1-week and 2-weeks post-delivery, and additional lactation consults at common periods of MOM decline (e.g., 1 month) will be offered.

Sessions span 10-60 minutes and lactation specialists will use MIACT strategies, based on each mothers' needs to: (1) assess current MOM-feeding motivation (via R-I-C rulers \[see Table 1\]), (2) discuss challenges; (3) identify obstacles (e.g., lack of perceived control); (4) foster learning/practice of acceptance and willingness (i.e., alternative skills); and, (5) encourage value-based goals (i.e., initiate/sustain MOM feeding). Follow-up consults will revisit content and obstacles, review progress, re-assess motivation, practice alternative skills, identify new strategies, and affirm value-based action.

Usual Lactation Support

Conventional lactation visits, during which specialists often guide, observe, and troubleshoot with mothers. The lactation service consults mothers in <24 hours, again <48 hours, and at 1-week and 2-weeks post-delivery.

Primary outcome measure

  • Proportion of infants who receive mothers' own (breast)milk (MOM) feeding within 24 hours of infant neonatal intensive care unit (NICU) discharge [ Time Frame: Within 24 hours of infant hospital discharge from the NICU ]

Central Contacts and Locations

Central contacts

Thomas F Northrup, PhD

713-500-7590Thomas.F.Northrup@uth.tmc.edu

Angela Stotts

(713) 500-7590Angela.L.Stotts@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Thomas F Northrup, PhD

(713) 500-7590Thomas.F.Northrup@uth.tmc.edu

Angela Stotts

(713) 500-7590Angela.L.Stotts@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Keywords

  • breast feeding
  • neonatal intensive care unit (NICU)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.