Actively Recruiting
Effects of Maternal Stress on Human Milk Composition and Subsequent Infant Outcomes
Led by University of Idaho · Updated on 2025-05-18
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Idaho
Lead Sponsor
O
Oregon State University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to find out whether an 8-week mindfulness-based program focused on self-compassion (MBSC) or daily vitamin D supplementation can reduce stress and boost self-compassion in mothers of preterm babies. It also explores if these approaches can positively change the composition of the mother's milk and improve infant health. The study includes mothers of newborns admitted to a hospital NICU and term infants from a nearby region. Participants are randomly assigned to one of three groups: standard care (control), the MBSC program, or vitamin D supplements (2000 IU daily for 8 weeks). The MBSC group joins guided meditation sessions, daily mindfulness practices, prompts, and group video calls led by a certified instructor. The control group receives access to the MBSC program after the study and placebo gummies resembling vitamin D supplements. Throughout the study, mothers complete stress and self-compassion questionnaires at the start, fourth week, and end of the 8-week period. Researchers collect saliva, urine, stool, and milk samples from mothers and infants to measure stress hormones, milk proteins, and markers of infant oxidative stress and inflammation. Data on maternal health, infant birth details, nutrition, and growth are also gathered. This comprehensive monitoring helps evaluate changes linked to the interventions over time.
CONDITIONS
Brief Title
Maternal Stress on Human Milk and Infant Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mothers of newborn infants at Kootenai Health NICU and the Palouse region
- Female participants aged 18 to 50 years
- Willing and able to participate in an 8-week mindfulness program or take daily vitamin D supplements
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants engage in an 8-week intervention which may include a mindfulness program focused on self-compassion, daily vitamin D supplementation, or standard care as control.
Four video conference group sessions and daily activities for mindfulness group; daily vitamin D intake for supplementation group
Duration - Up to 8 weeks post-intervention
Participants complete follow-up assessments of stress, self-compassion, and biological sample collections to evaluate changes from baseline to 4 and 8 weeks.
Assessments and sample collections at baseline, 4 weeks, and 8 weeks
Trial Site Locations
Total: 1 location
1
Kootenai Health
Coeur d'Alene, Idaho, United States, 83814
Actively Recruiting
Research Team
Y
Yimin Chen, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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