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Maternal Stress on Human Milk and Infant Outcomes

NCT04821544 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-05-18

No results posted yet for this study

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

Interventions

BEHAVIORAL

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

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

DIETARY_SUPPLEMENT

Vitamin D

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

Sponsors & Collaborators

  • Oregon State University

    collaborator OTHER

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • Kootenai Health

    collaborator OTHER

  • University of Idaho

    lead OTHER

Principal Investigators

  • Yimin Chen, PhD · University of Idaho

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04821544 on ClinicalTrials.gov