Maternal Stress on Human Milk and Infant Outcomes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity of Idaho
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Mothers of newborn infants at Kootenai Health NICU and the Palouse region
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness-based intervention (with a focus on self-compassion; MBSC)
Behavioral8-week MBSC intervention with a focus on increasing self-compassion
Vitamin D
Dietary supplementVitamin D at 2,000 IU/day for 8 weeks.
Treatment groups
500 Participants
are divided into 3 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: Mindfulness-based intervention (with a focus on self-compassion; MBSC)Experimental treatment 1 intervention
Group C: Vitamin DExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maternal Stress - Biomarker Change
Salivary cortisol - Change from Baseline cortisol to 4 and 8 weeks
Time frame
Baseline to 4 and 8 weeks2
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.
Time frame
Baseline to 4 and 8 weeks3
Maternal Self-compassion - Biomarker Change
Salivary oxytocin - Change from Baseline oxytocin to 4 and 8 weeks
Time frame
Baseline to 4 and 8 weeks4
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.
Time frame
Baseline to 4 and 8 weeksSecondary outcomes
1
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.
Time frame
Baseline to 4 and 8 weeks2
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.
Time frame
Baseline to 4 and 8 weeks3
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.
Time frame
Baseline to 4 and 8 weeks4
Maternal Vitamin D Changes
Maternal vitamin D status changes in both serum and human milk from baseline to 4 and 8 weeks.
Time frame
Baseline to 4 and 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Idaho
Lead sponsor
Oregon State University
Collaborator
National Institute of General Medical Sciences (NIGMS)
Collaborator
Kootenai Health
Collaborator
Source ClinicalTrials.gov