Maternal Stress on Human Milk and Infant Outcomes Study
This study is looking at how stress in mothers of newborn infants might affect their breast milk and their baby's health. We are testing two different approaches: an 8-week mindfulness-based intervention (MBSC) that focuses on self-compassion, and an 8-week daily vitamin D supplement (2,000 IU/day). We want to see if these interventions can reduce stress and increase self-compassion in mothers, and if they can positively change breast milk and improve infant health. We are looking for mothers aged 18 to 50 who have newborn infants in the Kootenai Health NICU or the Palouse region. The main goals are to measure changes in maternal stress and self-compassion using both biological markers and questionnaires over 8 weeks. The study plans to enroll 500 participants, but its current status is unclear.
- Study design
- This is an interventional study where participants are randomly assigned to receive either standard care, the mindfulness intervention, or vitamin D supplementation. The study aims to enroll 500 participants.
- What's involved
- Participants will provide saliva, urine, stool, and human milk samples at the start, at 4 weeks, and at 8 weeks. They will also complete questionnaires about stress and self-compassion at these same time points. The mindfulness group will participate in daily practices, guided meditations, routine prompts, and four video conference group sessions.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 8 weeks, with measurements taken at baseline, 4 weeks, and 8 weeks.
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Maternal Stress on Human Milk and Infant Outcomes
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Yimin Chen, PhD · PRINCIPAL_INVESTIGATOR · University of Idaho
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Maternal Stress - Biomarker ChangeBaseline to 4 and 8 weeks
Salivary cortisol - Change from Baseline cortisol to 4 and 8 weeks
- Maternal Stress - Psychometric Measure ChangeBaseline to 4 and 8 weeks
Perceived Stress Scale (PSS) - Change from Baseline PSS to 4 and 8 weeks The Perceived Stress Scale (PSS) is validated and the most widely used instrument to measure perception of stress. The PSS includes 14 questions inquiring about feelings and thoughts during the past month expressed through frequency. The PSS will be used pre-intervention, post-intervention (8 weeks), and at the mid-point of the intervention (4 weeks). The scale for each question ranges from 0-4. The PSS measures how often the responder found life to be unpredictable, uncontrollable, and overloaded. Higher score indicates higher perceived stress. The total score ranges between 0-56.
- Maternal Self-compassion - Biomarker ChangeBaseline to 4 and 8 weeks
Salivary oxytocin - Change from Baseline oxytocin to 4 and 8 weeks
- Maternal Self-compassion - Psychometric Measure ChangeBaseline to 4 and 8 weeks
Self-Compassion Scale-Short Form (SCS-SF) - Change from Baseline SCS-SF to 4 and 8 weeks The Self-Compassion Scale-Short Form (SCS-SF)19 is a shortened and highly correlated (r ≥ 0.97) scale (12 items) from the original 26-item SCS. The SCS-SF measures six key components of self-compassion using a scale that ranges from 1-5: self-kindness, self-judgement, common humanity, isolation, mindfulness, and over-identification. Self-compassion is associated with psychological well-being and is therefore often measured alongside stress and anxiety. High score indicates higher self-compassion. The total score ranges between 0-60.