Recruiting

Observational Study

Sponsor:

University of Idaho

Code:

NCT04821544

Conditions

Postpartum Depression

Preterm Labor

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

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

Vitamin D

Study Details

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

Study ID

NCT04821544

Start date

May 1, 2021

Status verified date

May, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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: 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.

experimental: Vitamin D

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

Interventions

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

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

Vitamin D

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

Primary outcome measure

  • Maternal Stress - Biomarker Change [ Time Frame: Baseline to 4 and 8 weeks ]
  • Maternal Stress - Psychometric Measure Change [ Time Frame: Baseline to 4 and 8 weeks ]
  • Maternal Self-compassion - Biomarker Change [ Time Frame: Baseline to 4 and 8 weeks ]
  • Maternal Self-compassion - Psychometric Measure Change [ Time Frame: Baseline to 4 and 8 weeks ]

Central Contacts and Locations

Central contacts

Yimin Chen, PhD

2088857264yiminc@uidaho.edu

Locations

Kootenai Health

Recruiting

Coeur d'Alene, Idaho, United States, 83814

More Information

Sponsor

University of Idaho

Last update posted

May 18, 2025

Last verified

May, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Idaho on 2025-05-18.