Postpartum DepressionNCT04821544
Maternal Stress on Human Milk and Infant Outcomes
A study testing Mindfulness-based intervention (with a focus on self-compassion; MBSC) and Vitamin D in people with Postpartum Depression and Preterm Labor, run by University of Idaho at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Postpartum Depression, Preterm Labor
- What is being tested?
- Mindfulness-based intervention (with a focus on self-compassion; MBSC) and Vitamin D
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Mothers of newborn infants at Kootenai Health NICU and the Palouse region
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kootenai Health
Coeur d'Alene, Idaho, 83814
Brook Lang, MD
About this study
Official title: Effects of Maternal Stress on Human Milk Composition and Subsequent Infant Outcomes
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.
Read the detailed description
During every two-week period, newly admitted infants (both preterm <37 weeks gestational age and term ≥37 weeks gestational age) at performance site Kootenai Health NICU and term infants from the Palouse region will be block randomized to control (standard of care), mindfulness intervention (modified 8-week mindfulness
-based intervention (with a focus on self-compassion; MBSC), or vitamin D supplementation (8-week 2,000 IU vitamin D3 supplementation) groups. The purpose of the nested cohorts is to minimize the postpartum time difference among cohort mothers. Each nested MBSC cohort will undergo the 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.
Maternal data: The Perceived Stress Scale (PSS) and Self-Compassion Scale-Short Form (SCS-SF) will be given to mothers from both groups pre- and post-intervention, and during the 4th week. Saliva, urine, stool, and human milk samples will be collected at the same time points as above. Additional maternal data include: age, race, height, weight (pre-pregnancy and last weight before delivery), parity, delivery mode, chorioamnionitis, preeclampsia, HELLP (hemolysis, elevated liver enzymes, and low platelet) syndrome, antenatal antibiotics, anti-depressants or other mood-altering/neurochemical medications (current and during pregnancy), diagnosis of depression or other mental illness within the previous 5 years, history of postpartum depression and postpartum psychosis, diabetes, hypertension, heart disease, and any inflammatory or autoimmune diseases.
Infant data: Gestational age, birth weight, ventilation requirement, surgical interventions, patent ductus arteriosus, growth, nutrition prescriptions, saliva, urine and stool samples.
Data collection: All data (not including biosamples) will be collected using REDCap hosted within the UI system.
Sample measurements: Maternal salivary cortisol (marker of stress) and oxytocin (marker of anxiety and "social-closeness") concentrations will be measured using ELISA. Human milk proteins will be identified using mass spectrometry-based proteomics. Following proteomic analyses, targeted proteins will be quantified using ELISA and Western Blot. Both maternal and infant saliva, urine and stool samples will be used for metabolomic and transcriptomic sequencing to identify metabolic and molecular changes, respectively, in both mothers and infants. Infant systemic oxidative stress will be measured through urine F2-isoprostanes concentrations (ELISA), and infant intestinal inflammation will be determined with stool calprotectin concentrations (ELISA).
- Conditions
- Postpartum Depression, Preterm Labor
- Being tested
- Mindfulness-based intervention (with a focus on self-compassion; MBSC), Vitamin D
- Keywords
- Maternal stress, Mindfulness, Human milk bioactives, Infant metabolome, Maternal transcriptome, Infant transcriptome
- Medical subject headings
- Depression, Postpartum, Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based intervention (with a focus on self-compassion; MBSC)Behavioural
8-week MBSC intervention with a focus on increasing self-compassion
Vitamin DDietary supplement
Vitamin D at 2,000 IU/day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Stress - Biomarker Change
Salivary cortisol - Change from Baseline cortisol to 4 and 8 weeks
Measured: 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.
Measured: Baseline to 4 and 8 weeks
Maternal Self-compassion - Biomarker Change
Salivary oxytocin - Change from Baseline oxytocin to 4 and 8 weeks
Measured: 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.
Measured: Baseline to 4 and 8 weeks
Secondary outcomes (4)
Human Milk Proteins & Peptides Change
Protein and peptide profiles will be measured using proteomic \& peptidomic analyses to assess human milk protein and peptide changes from baseline to 4 and 8 weeks as a function of maternal changes in stress/self-compassion. These are measured outcomes.
Measured: Baseline to 4 and 8 weeks
Maternal Metabolomic & Transcriptomic Changes
Maternal metabolomic pathways \& gene activation changes from baseline to 4 and 8 weeks in response to changes in stress/self-compassion. These are measured outcomes.
Measured: Baseline to 4 and 8 weeks
Infant Metabolomic & Transcriptomic Changes
Infant metabolomic pathways \& gene activation changes from baseline to 4 and 8 weeks in response to maternal changes in stress/self-compassion, and human milk protein/peptide profile changes. These are measured outcomes.
Measured: Baseline to 4 and 8 weeks
Maternal Vitamin D Changes
Maternal vitamin D status changes in both serum and human milk from baseline to 4 and 8 weeks.
Measured: Baseline to 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 May 2021
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Idaho
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon State University, National Institute of General Medical Sciences (NIGMS), Kootenai Health
- Responsible party
- Principal investigator, Yimin Chen, University of Idaho
- Investigators
- Yimin Chen, PhD, Principal investigator, University of Idaho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821544
- Sponsor's protocol ID
- 20-024
- Other IDs
- 5U54GM104944-08, P20GM152304
- Status last verified
- Sep 2025
- First submitted
- 17 Nov 2020
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Maternal Stress on Human Milk Composition and Subsequent Infant Outcomes
- ClinicalTrials.gov ID
- NCT04821544
- Acronym / sponsor ID
- 20-024
- Conditions
- Postpartum Depression, Preterm Labor
- Keywords
- Maternal stress, Mindfulness, Human milk bioactives, Infant metabolome, Maternal transcriptome, Infant transcriptome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of IdahoUniversity, hospital or other
- Collaborators
- Oregon State University, National Institute of General Medical Sciences (NIGMS), Kootenai Health
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
During every two-week period, newly admitted infants (both preterm <37 weeks gestational age and term ≥37 weeks gestational age) at performance site Kootenai Health NICU and term infants from the Palouse region will be block randomized to control (standard of care), mindfulness intervention (modified 8-week mindfulness
-based intervention (with a focus on self-compassion; MBSC), or vitamin D supplementation (8-week 2,000 IU vitamin D3 supplementation) groups. The purpose of the nested cohorts is to minimize the postpartum time difference among cohort mothers. Each nested MBSC cohort will undergo the 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.
Maternal data: The Perceived Stress Scale (PSS) and Self-Compassion Scale-Short Form (SCS-SF) will be given to mothers from both groups pre- and post-intervention, and during the 4th week. Saliva, urine, stool, and human milk samples will be collected at the same time points as above. Additional maternal data include: age, race, height, weight (pre-pregnancy and last weight before delivery), parity, delivery mode, chorioamnionitis, preeclampsia, HELLP (hemolysis, elevated liver enzymes, and low platelet) syndrome, antenatal antibiotics, anti-depressants or other mood-altering/neurochemical medications (current and during pregnancy), diagnosis of depression or other mental illness within the previous 5 years, history of postpartum depression and postpartum psychosis, diabetes, hypertension, heart disease, and any inflammatory or autoimmune diseases.
Infant data: Gestational age, birth weight, ventilation requirement, surgical interventions, patent ductus arteriosus, growth, nutrition prescriptions, saliva, urine and stool samples.
Data collection: All data (not including biosamples) will be collected using REDCap hosted within the UI system.
Sample measurements: Maternal salivary cortisol (marker of stress) and oxytocin (marker of anxiety and "social-closeness") concentrations will be measured using ELISA. Human milk proteins will be identified using mass spectrometry-based proteomics. Following proteomic analyses, targeted proteins will be quantified using ELISA and Western Blot. Both maternal and infant saliva, urine and stool samples will be used for metabolomic and transcriptomic sequencing to identify metabolic and molecular changes, respectively, in both mothers and infants. Infant systemic oxidative stress will be measured through urine F2-isoprostanes concentrations (ELISA), and infant intestinal inflammation will be determined with stool calprotectin concentrations (ELISA).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: 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. |
| Vitamin D | Experimental | Dietary Supplement: Vitamin DVitamin D gummies of 2,000 IU/day for 8 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Mothers of newborn infants at Kootenai Health NICU and the Palouse region
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based intervention (with a focus on self-compassion; MBSC)8-week MBSC intervention with a focus on increasing self-compassion | Behavioural | Mindfulness-based intervention (with a focus on self-compassion; MBSC) |
| Vitamin DVitamin D at 2,000 IU/day for 8 weeks. | Dietary supplement | Vitamin D |
Primary outcome
Maternal Stress - Biomarker Change
Time frame: Baseline to 4 and 8 weeks
Salivary cortisol - Change from Baseline cortisol to 4 and 8 weeks
Maternal Stress - Psychometric Measure Change
Time frame: Baseline to 4 and 8 weeks
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.
Maternal Self-compassion - Biomarker Change
Time frame: Baseline to 4 and 8 weeks
Salivary oxytocin - Change from Baseline oxytocin to 4 and 8 weeks
Maternal Self-compassion - Psychometric Measure Change
Time frame: Baseline to 4 and 8 weeks
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.
4 secondary outcomes
Human Milk Proteins & Peptides Change
Time frame: Baseline to 4 and 8 weeks
Maternal Metabolomic & Transcriptomic Changes
Time frame: Baseline to 4 and 8 weeks
Infant Metabolomic & Transcriptomic Changes
Time frame: Baseline to 4 and 8 weeks
Maternal Vitamin D Changes
Time frame: Baseline to 4 and 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No. IPD will be available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yimin Chen, PhD principal investigator
University of Idaho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based intervention (with a focus on self-compassion; MBSC) and Vitamin D in people with Postpartum Depression and Preterm Labor, run by University of Idaho at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yimin Chen, PhD (2088857264, yiminc@uidaho.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Stress - Biomarker Change (time frame: Baseline to 4 and 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.