Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2021-05-01
2027-06-30
Brief Summary
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Detailed Description
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-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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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.
No interventions assigned to this group
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.
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 gummies of 2,000 IU/day for 8 weeks.
Vitamin D
Vitamin D at 2,000 IU/day for 8 weeks.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
50 Years
FEMALE
No
Sponsors
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Oregon State University
OTHER
National Institute of General Medical Sciences (NIGMS)
NIH
Kootenai Health
OTHER
University of Idaho
OTHER
Responsible Party
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Yimin Chen
Assistant Professor
Principal Investigators
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Yimin Chen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Idaho
Locations
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Kootenai Health
Coeur d'Alene, Idaho, United States
Countries
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Central Contacts
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Facility Contacts
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Brook Lang, MD
Role: primary
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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