Maternal Stress on Human Milk and Infant Outcomes

Effects of Maternal Stress on Human Milk Composition and Subsequent Infant Outcomes

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.

Study Overview

• Status: Recruiting
• Conditions: Postpartum Depression; Preterm Labor
• Intervention / Treatment: Behavioral: Mindfulness-based intervention (with a focus on self-compassion; MBSC); Dietary supplement: Vitamin D

Detailed Description

During every two-week period, newly admitted infants (both preterm <37 weeks gestational age and term ≥37 weeks gestational age) at performance site Kootenai Health NICU and term infants from the Palouse region will be block randomized to control (standard of care), mindfulness intervention (modified 8-week mindfulness

-based intervention (with a focus on self-compassion; MBSC), or vitamin D supplementation (8-week 2,000 IU vitamin D3 supplementation) groups. The purpose of the nested cohorts is to minimize the postpartum time difference among cohort mothers. Each nested MBSC cohort will undergo the 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.

Maternal data: The Perceived Stress Scale (PSS) and Self-Compassion Scale-Short Form (SCS-SF) will be given to mothers from both groups pre- and post-intervention, and during the 4th week. Saliva, urine, stool, and human milk samples will be collected at the same time points as above. Additional maternal data include: age, race, height, weight (pre-pregnancy and last weight before delivery), parity, delivery mode, chorioamnionitis, preeclampsia, HELLP (hemolysis, elevated liver enzymes, and low platelet) syndrome, antenatal antibiotics, anti-depressants or other mood-altering/neurochemical medications (current and during pregnancy), diagnosis of depression or other mental illness within the previous 5 years, history of postpartum depression and postpartum psychosis, diabetes, hypertension, heart disease, and any inflammatory or autoimmune diseases.

Infant data: Gestational age, birth weight, ventilation requirement, surgical interventions, patent ductus arteriosus, growth, nutrition prescriptions, saliva, urine and stool samples.

Data collection: All data (not including biosamples) will be collected using REDCap hosted within the UI system.

Sample measurements: Maternal salivary cortisol (marker of stress) and oxytocin (marker of anxiety and "social-closeness") concentrations will be measured using ELISA. Human milk proteins will be identified using mass spectrometry-based proteomics. Following proteomic analyses, targeted proteins will be quantified using ELISA and Western Blot. Both maternal and infant saliva, urine and stool samples will be used for metabolomic and transcriptomic sequencing to identify metabolic and molecular changes, respectively, in both mothers and infants. Infant systemic oxidative stress will be measured through urine F2-isoprostanes concentrations (ELISA), and infant intestinal inflammation will be determined with stool calprotectin concentrations (ELISA).

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yimin Chen, PhD; Phone Number: 2088857264; Email: yiminc@uidaho.edu

Study Locations

• United States
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • Recruiting
      • Kootenai Health
      • Contact: Brook Lang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Mothers of newborn infants at Kootenai Health NICU and the Palouse region

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-based intervention (with a focus on self-compassion; MBSC); 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.	Behavioral: Mindfulness-based intervention (with a focus on self-compassion; MBSC); 8-week MBSC intervention with a focus on increasing self-compassion
No Intervention: Control; 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.
Experimental: Vitamin D; Vitamin D gummies of 2,000 IU/day for 8 weeks.	Dietary supplement: Vitamin D; Vitamin D at 2,000 IU/day for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Stress - Biomarker Change	Salivary cortisol - Change from Baseline cortisol to 4 and 8 weeks	Baseline to 4 and 8 weeks
Maternal Stress - Psychometric Measure Change	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.	Baseline to 4 and 8 weeks
Maternal Self-compassion - Biomarker Change	Salivary oxytocin - Change from Baseline oxytocin to 4 and 8 weeks	Baseline to 4 and 8 weeks
Maternal Self-compassion - Psychometric Measure Change	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.	Baseline to 4 and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Human Milk Proteins & Peptides Change	Protein and peptide profiles will be measured using proteomic & peptidomic analyses to assess human milk protein and peptide changes from baseline to 4 and 8 weeks as a function of maternal changes in stress/self-compassion. These are measured outcomes.	Baseline to 4 and 8 weeks
Maternal Metabolomic & Transcriptomic Changes	Maternal metabolomic pathways & gene activation changes from baseline to 4 and 8 weeks in response to changes in stress/self-compassion. These are measured outcomes.	Baseline to 4 and 8 weeks
Infant Metabolomic & Transcriptomic Changes	Infant metabolomic pathways & gene activation changes from baseline to 4 and 8 weeks in response to maternal changes in stress/self-compassion, and human milk protein/peptide profile changes. These are measured outcomes.	Baseline to 4 and 8 weeks
Maternal Vitamin D Changes	Maternal vitamin D status changes in both serum and human milk from baseline to 4 and 8 weeks.	Baseline to 4 and 8 weeks

Collaborators and Investigators

• Sponsor: University of Idaho
• Collaborators: National Institute of General Medical Sciences (NIGMS); Oregon State University; Kootenai Health
• Investigators: Principal Investigator: Yimin Chen, PhD, University of Idaho

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Mindfulness; Maternal stress; Human milk bioactives; Infant metabolome; Maternal transcriptome; Infant transcriptome
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Mood Disorders; Puerperal Disorders; Depressive Disorder; Depression, Postpartum; Obstetric Labor, Premature; Physiological Effects of Drugs; Bone Density Conservation Agents; Micronutrients; Vitamins; Vitamin D
• Other Study ID Numbers: 20-024; 5U54GM104944-08 (U.S. NIH Grant/Contract); P20GM152304 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be available upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No