An interventional study of Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT) (MIACT) and Usual Lactation Support in Mothers' Own Milk Feeding and Cessation or Non-initiation of Mothers' Own Milk Feeding, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Prevention
Among 251 studies in Breast Feeding with a site in United States — 44 open to participants now, 49 under way, none of them phase 3. Breast Feeding · United States.
Among the 251 studies in Breast Feeding with a site in United States, this one is the 12th largest by planned enrollment of the 202 interventional ones that give a count, is one of 14 that started in 2026, is one of 164 with no phase, reaches primary completion later than 31 of the 48 other live ones, and was the 251st registered.
1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.
Browse Breast Feeding studies →44 of the 251 studies in Breast Feeding with a site in United States are open now. Recruiting first, the newest first:
University of Illinois at Urbana-Champaign · Sites in United States
Ages 21–45 · Women only · Healthy volunteers
Eli Lilly and Company · Sites in United States, Canada, Denmark and 4 more countries
Ages 3 wk+ · Women only
University of Alabama at Birmingham · Sites in United States
Ages 18–50 · Women only
University of Colorado, Denver · Sites in United States
Women only · Healthy volunteers
Loma Linda University · Sites in United States
Ages 18–45 · Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 126 Breast Feeding studies recruiting now, 66 (52%) set no upper age limit and 58 (46%) stop at 75 or younger; 54 take children under 18; 76 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
251 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 10 · Phase 3 6 · Phase 4 14
First in 2000; this study’s year is marked. 14 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,176 is above the median of 100 across 844 interventional studies indexed under Breast Feeding.
Median enrollment 83 across the 202 interventional studies, 88 across the 49 observational. Of the 180 that completed or were terminated, 46 (26%) have results posted.
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22 of 251 have an industry lead sponsor. The 10 most frequent:
The University of Texas Health Science Center, Houston is the lead sponsor of 899 studies on the registry; 215 are open to participants now.
Of its 174 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
The University of Texas Health Science Center, Houston has 1 study filed under Breast Feeding — fewer than ten, so there is no comparison to draw.
15 of the studies in Breast Feeding with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07176793University of California, DavisPregnancy and Postpartum Breastfeeding Support for Patients With Gestational Diabetes | 2026-12-30 |
| NCT05457972University Hospitals Cleveland Medical CenterPostpartum Vaginal Estrogen for Breastfeeding Patients | 2026-12-31 |
| NCT06107933Johns Hopkins Bloomberg School of Public HealthDevelopmental Impacts of Microplastics Exposure in Early Life | 2026-12-31 |
| NCT05441709Endeavor HealthFurthering Equity Through Infant Feeding EDucation and Support | 2026-12-31 |
| NCT03838536University of North Carolina, Chapel HillSynergistic Activity of Human Milk Nutrients and Infant Cognition | 2027-03 |
Add all 15 to your calendar (.ics) → With an account.
Among the 251 studies in Breast Feeding with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT) (MIACT) · Behavioral: Usual Lactation Support
Behavioral: Usual Lactation Support
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.
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.
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
Number of infants' mothers who initiate mothers' own (breast)milk (MOM) feeding
Time frame: From the time of infant date of birth to 6 months chronological age of infant (about 6 months)
Total number of days from infant mothers' own (breast)milk (MOM) feeding initiation to cessation
Time frame: From the time of infant date of birth to 6 months chronological age of infant (about 6 months)
Proportion of days that infants receive mothers' own (breast)milk (MOM) during neonatal intensive care unit hospitalization
Time frame: From the time of infant admission to NICU to time of infant hospital discharge from NICU (1-180 days)
Feasibility of intervention training as indicated by number of training sessions attended by nurses specializing in lactation support as assessed by sign-in attendance logs
Time frame: From start to finish of training (3 non-consecutive days)
Acceptability of Lactation Specialist (LS) intervention training and MIACT as assessed by completion of self-report evaluations completed by lactation specialists
Self-reported ratings of LS intervention training and MIACT will be completed by nurses specializing in lactation support (i.e., lactation specialists) to assess intervention acceptability. Total score ranges from 1 (highly unacceptable) to 7 (highly acceptable).
Time frame: After initial MIACT training and at study closeout
Acceptability of LS intervention as assessed by completion of self-report evaluations completed by mothers
Self-reported ratings of LS intervention will be completed by mothers to assess intervention acceptability. Total score ranges from 1 (strongly disagree) to 7 (strongly agree).
Time frame: At time of infant hospital discharge from NICU (1-180 days after admission to NICU)
Intervention implementation adherence as indicated by percentage of MIACT components delivered as assessed by MIACT intervention checklists completed by lactation specialists
Time frame: During the time of MIACT intervention implementation (about 9 months)
Total number of days infant is in the NICU
Time frame: From the time of infant admission to NICU to time of infant hospital discharge form NICU (1-180 days after admission to NICU)
Number of lactation referrals
Time frame: From the time of infant admission to NICU to time of infant hospital discharge form NICU (1-180 days after admission to NICU)
Mother-to-infant bonding as assessed by the Mother-to-Infant Bonding Scale
Total score ranges from 0 to 24, with higher scores indicating greater levels of bonding difficulties or weaker emotional ties.
Time frame: Baseline and at infant hospital discharge from the NICU (1-180 days after admission to NICU)).
Maternal depressive symptoms as assessed by score on the Center for Epidemiological Studies Depression Scale
Total score ranges from 0 to 60, with a higher score indicating greater frequency and severity of depressive symptoms
Time frame: Baseline, at infant hospital discharge from the neonatal intensive care unit (NICU), and when infants reach 6 months of chronological age
NICU stress as assessed by the Parental Stressor Scale (Neonatal Intensive Care Unit)
Total subscales and overall scores range from item averages of 1 (not at all stressful) to 5 (extremely stressful).
Time frame: Baseline or at infant hospital discharge from the NICU (1-180 days after admission to NICU).
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Mar 2028, 17 months after the start.
Of 502 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 17 months is above that.
Counting every sponsor, half of 510 studies reached it within 12 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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The University of Texas Health Science Center, Houston →