Mindfulness and Vitamin D for Mothers of Preterm Infants
Effects of Maternal Stress on Human Milk Composition and Subsequent Infant Outcomes
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Idaho Academic / other |
| Locations | 1 site (Coeur d'Alene, Idaho) |
| Trial ID | NCT04821544 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promising results with mindfulness interventions in maternal health, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Mothers of newborn infants at Kootenai Health NICU and the Palouse region Exclusion Criteria: \-
Where this trial is running
Coeur d'Alene, Idaho
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.