Maternal Stress on Human Milk and Infant Outcomes
Key facts
- Who runs it
- University of Idaho
- Where
- Coeur d'Alene, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 500 people, planned
- Started
- 1 May 2021
- Expected to end
- 30 Jun 2027
- Type of study
- Interventional, 3 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Mindfulness-based intervention (with a focus on self-compassion; MBSC)
- Vitamin D
- Record updated
- 10 November 2026
Who can take part
- Age
- 18 years to 50 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- Mothers of newborn infants at Kootenai Health NICU and the Palouse region
Who cannot take part
- -
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 50 years old?
Where in United States
- Kootenai HealthCoeur d'Alene, United StatesContact: Brook Lang, MDTaking people
About the trial
What the trial wants to find out
The overarching purpose of this study is to determine if a modified 8-week mindfulness-based intervention (with a focus on self-compassion; MBSC) or 8 weeks of 2000 IU vitamin D supplementation will reduce stress and increase self-compassion in mothers of preterm infants and beneficially modify the human milk produced, and subsequently improve infant health.
The 3 groups in the trial
- ControlNo study treatment, for comparison
Control group will receive link to a free 8-week Mindfulness Based Stress Reduction intervention AFTER the 8-weel trial period. This group will also receive placebo gummies that appear the same as the vitamin D gummies.
- Mindfulness-based intervention (with a focus on self-compassion; MBSC)Treatment being tested
8-week MBSC intervention with a focus on increasing self-compassion. The MBSC program includes previously developed daily mindfulness practices, guided meditations, routine mindfulness prompts, and four video conference group sessions with a certified mindfulness facilitator.
- Vitamin DTreatment being tested
Vitamin D gummies of 2,000 IU/day for 8 weeks.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effects of Maternal Stress on Human Milk Composition and Subsequent Infant Outcomes
- Fit questions
- Built from NCT04821544, who can take part
- Record updated
- 10 November 2026