Maternal Stress on Human Milk and Infant Outcomes

Part of paid clinical trials in Coeur d'Alene, Idaho.

Sponsor
University of Idaho
Study ID
NCT04821544
Status
Recruiting
Apply to this trial

Conditions

  • Postpartum Depression
  • Preterm Labor

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Mindfulness-based intervention (with a focus on self-compassion; MBSC) — BEHAVIORAL
    8-week MBSC intervention with a focus on increasing self-compassion
  • Vitamin D — DIETARY_SUPPLEMENT
    Vitamin D at 2,000 IU/day for 8 weeks.

Study Details

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.

Key Dates

Start date
May 1, 2021
Status verified
May 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

Maternal Stress - Biomarker Change [ Time Frame: Baseline to 4 and 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kootenai HealthCoeur d'AleneIdaho83814
Brook Lang, MD

Find similar trials in Coeur d'Alene, ID

By research site
Kootenai Health· Coeur d'Alene, ID

Related Studies