Mindfulness and Vitamin D for Mothers of Preterm Infants
Official title: Effects of Maternal Stress on Human Milk Composition and Subsequent Infant Outcomes
Run by University of Idaho · NCT04821544 · Data updated 2026-11-12
This study tests if an 8-week mindfulness program and vitamin D supplements can help mothers of preterm infants feel less stressed and improve the quality of their milk.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 500 (estimated) |
| Sponsor | University of Idaho Academic / other |
| Locations | 1 site (Coeur d'Alene, Idaho) |
| Status | Recruiting |
| Started | May 1, 2021 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT04821544 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are mothers of newborn infants, particularly those with preterm infants, at Kootenai Health NICU and in the Palouse region.
✕Probably not a fit
Patients who are not mothers of newborn infants or those who do not have access to the study locations may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of an 8-week mindfulness-based intervention focused on self-compassion and vitamin D supplementation on maternal stress and human milk composition in mothers of preterm infants. Participants will be block randomized into three groups: standard care, mindfulness intervention, or vitamin D supplementation. Maternal stress levels and self-compassion will be assessed using validated scales, and biological samples will be collected to analyze changes in human milk and infant health outcomes. The goal is to determine if these interventions can improve maternal well-being and infant health.
Why it matters
Potential benefit: If successful, this study could enhance maternal mental health and improve the nutritional quality of human milk, leading to better health outcomes for infants.
How similar studies have gone: Other studies have shown promising results with mindfulness interventions in maternal health, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Mothers of newborn infants at Kootenai Health NICU and the Palouse region Exclusion Criteria: \-
Where it's running
-
Kootenai Health
Coeur d'Alene, Idaho, United States Recruiting
Study contacts
- Principal investigator: Yimin Chen, PhD — University of Idaho
- Study coordinator: Yimin Chen, PhD
- Email: yiminc@uidaho.edu
- Phone: 2088857264
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.