Maternal Stress on Human Milk and Infant Outcomes

NCT04821544 | Recruiting

• 3 other identifiers: 20-0245U54GM104944-08P20GM152304
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postpartum Depression; Preterm Labor

Keywords

Maternal stress; Mindfulness; Human milk bioactives; Infant metabolome; Maternal transcriptome; Infant transcriptome

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Human Milk Proteins & Peptides Change

  Baseline to 4 and 8 weeks

• Maternal Metabolomic & Transcriptomic Changes

  Baseline to 4 and 8 weeks

• Infant Metabolomic & Transcriptomic Changes

  Baseline to 4 and 8 weeks

• Maternal Vitamin D Changes

  Baseline to 4 and 8 weeks

Study Arms (3)

Control

NO INTERVENTION

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)

EXPERIMENTAL

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)

Vitamin D

EXPERIMENTAL

Vitamin D gummies of 2,000 IU/day for 8 weeks.

Dietary Supplement: Vitamin D

Interventions

Mindfulness-based intervention (with a focus on self-compassion; MBSC) BEHAVIORAL

8-week MBSC intervention with a focus on increasing self-compassion

Mindfulness-based intervention (with a focus on self-compassion; MBSC)

Vitamin D DIETARY_SUPPLEMENT

Vitamin D at 2,000 IU/day for 8 weeks.

Vitamin D

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• University of Idaho: lead
• Oregon State University: collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator
• Kootenai Health: collaborator

Study Sites (1)

Kootenai Health

Coeur d'Alene, Idaho, 83814, United States

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum; Obstetric Labor, Premature

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Obstetric Labor Complications

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Yimin Chen, PhD

  University of Idaho

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yimin Chen, PhD

CONTACT

2088857264; yiminc@uidaho.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: March 29, 2021
• Study Start: May 1, 2021
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)