Mindfulness-based intervention (with a focus on self-compassion; MBSC) / Vitamin D / Preterm Labor · Interventional Study

Maternal Stress on Human Milk and Infant Outcomes

ClinicalTrials.gov · September 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned interventional trial registered at ClinicalTrials.gov testing whether an 8-week mindfulness-based self-compassion intervention or vitamin D supplementation (2000 IU) can reduce maternal stress and increase self-compassion in mothers of preterm infants, with downstream effects on milk composition and infant health. No results have been posted in the registry, and recruitment remains ongoing.

What was studied

Interventional, Randomized, Parallel, Quadruple masking, Prevention purpose. Postpartum Depression, Preterm Labor; Female; age from 18 Years; to 50 Years. Intervention: Mindfulness-based intervention (with a focus on self-compas…; Vitamin D. Compared with: Control — No Intervention. n = 500. 1 site: United States.

Key findings

Safety

This is a registry record with no results posted; no efficacy or safety data are available.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a clinical trial registry record describing a planned interventional study with no results posted; enrollment is ongoing and outcome data have not yet been reported.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Maternal Stress - Biomarker Change (assessed at Baseline to 4 and 8 weeks); Maternal Stress - Psychometric Measure Change (assessed at Baseline to 4 and 8 weeks); Maternal Self-compassion - Biomarker Change (assessed at Baseline to 4 and 8 weeks); Maternal Self-compassion - Psychometric Measure Change (assessed at Baseline to 4 and 8 weeks)

DesignInterventional, Randomized, Parallel, Quadruple masking, Prevention purpose

PopulationPostpartum Depression, Preterm Labor; Female; age from 18 Years; to 50 Years

Sample size500

InterventionMindfulness-based intervention (with a focus on self-compas…; Vitamin D

ComparatorControl — No Intervention

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment500

Primary outcome measure 1Maternal Stress - Biomarker Change, Baseline to 4 and 8 weeks

Primary outcome measure 2Maternal Stress - Psychometric Measure Change, Baseline to 4 and 8 weeks

Primary outcome measure 3Maternal Self-compassion - Biomarker Change, Baseline to 4 and 8 weeks

Primary outcome measure 4Maternal Self-compassion - Psychometric Measure Change, Baseline to 4 and 8 weeks

Intervention duration8 weeks

Vitamin D dose2000 IU

Caveats

This is a registry record with no results posted; no efficacy or safety data are available.
Recruitment status is 'RECRUITING', indicating the study is ongoing and enrollment incomplete.
Study phase is listed as 'NA'; design details (randomization method, blinding, control group specification) are not disclosed in this registry entry.
Secondary outcomes and full eligibility criteria are not provided in the source text.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Interventional study with two active arms; phase not specified in registry.

Directness

moderate

Study targets maternal stress and self-compassion with planned measurement of biomarkers and psychometric outcomes.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Blinding, allocation concealment, and other design details not disclosed in registry entry.

Sample adequacy

moderate

Estimated enrollment 500 participants; adequacy for planned outcomes not justified in registry.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT04821544). This is a study registration, not published results. Lead sponsor: University of Idaho. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 500 participants (ESTIMATED). Conditions: Postpartum Depression, Preterm Labor. Interventions: BEHAVIORAL: Mindfulness-based intervention (with a focus on self-compassion; MBSC); DIETARY_SUPPLEMENT: Vitamin D. Primary outcome measures: Maternal Stress - Biomarker Change , Baseline to 4 and 8 weeks; Maternal Stress - Psychometric Measure Change , Baseline to 4 and 8 weeks; Maternal Self-compassion - Biomarker Change , Baseline to 4 and 8 weeks; Maternal Self-compassion - Psychometric Measure Change , Baseline to 4 and 8 weeks. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

University of IdahoMindfulness-based intervention (with a focus on self-compassion; MBSC)Vitamin DPreterm LaborNCT04821544Postpartum Depression