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CompletedNCT02400593HEELDUpdated Jul 15, 2016

Health Experiences & Early Life Disadvantages

An interventional study of Meditation Workshop in Early Life Adversity and Chronic Stress, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 35 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-15.

Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
113
Allocation
Randomized
Ages
35 Years to 64 Years
Sex
All
01

Study summary

Growing up in a low-income household has been shown to increase risk for, and susceptibility to many illnesses.The purpose of the study is to test an affective intervention for reversing biological risk factors, as related to childhood adversity, in midlife.

Participants will be asked to make two lab visits; attend six weekly, 1-hour meditation classes; as well as complete brief online daily surveys for 11 weeks, five biweekly surveys, and two 30-minute surveys prior to each lab visit. During the lab visits, participants will have their psychophysiology monitored for heart rate, blood pressure, respiration, and pulse. Participants will also have their blood drawn.

All surveys and questionnaires inquire about participants' current demographics, family history, perceptions about life and well-being, physical health, and monetary choices.

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Conditions studied

  • Early Life Adversity
  • Chronic Stress
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In context

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • fluent in written and spoken English
  • have daily access to internet and a computer

Exclusion criteria

Exclusion Criteria:

  • engaged in regular meditation practice, either recently or in the past
  • previously participated in a meditation study
  • have allergies to adhesive materials (includes latex)
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
113 participants (actual)

Study arms

  • Experimental
    Lovingkindness

    A six-week formal meditation workshop for 1 hour per week.

    Behavioral: Meditation Workshop

  • Placebo comparator
    Mindfulness

    A six-week formal meditation workshop for 1 hour per week.

    Behavioral: Meditation Workshop

Interventions

  • BehavioralMeditation Workshop

    Six weeks of formal instruction in Lovingkindness or Mindfulness meditation.

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What researchers measure

Primary outcomes

  1. Change in meditation time (Self-reported meditation time recorded daily)

    Self-reported meditation time recorded daily.

    Time frame: Weeks 3, 4, 5, 6, 7, 8, 9 ,10, 11, 12

Secondary outcomes

  1. Leukocyte basal gene expression (evaluated through blood samples)

    Gene expression evaluated through blood samples.

    Time frame: Week 0, Week 12

  2. Levels of mistrust (Self-report questionnaire measure of hostility using 9-item Cooke-Medley scale)

    Self-report questionnaire measure of hostility using 9-item Cooke-Medley scale.

    Time frame: Week 0, Week 12

  3. Temporal Discounting (Monetary choice questionnaire to assess impulsive decision-making)

    Monetary choice questionnaire to assess impulsive decision-making.

    Time frame: Week 0, Week 12

  4. Cardiac vagal tone (Respiration and echocardiogram measured with respiration band and 2-lead electrode placement)

    Respiration and echocardiogram measured with respiration band and 2-lead electrode placement, respectively. Three-minute spontaneous breath followed by five minutes of paced breathing intervals.

    Time frame: Week 0, Week 12

07

Study locations

1 site
  • UNC PEP Lab
    Chapel Hill, North Carolina 27514, United States
08

References and documents

Publications

  • Miller GE, Chen E, Fok AK, Walker H, Lim A, Nicholls EF, Cole S, Kobor MS. Low early-life social class leaves a biological residue manifested by decreased glucocorticoid and increased proinflammatory signaling. Proc Natl Acad Sci U S A. 2009 Aug 25;106(34):14716-21. doi: 10.1073/pnas.0902971106. Epub 2009 Jul 14. PubMed 19617551 ↗
  • Cohen S, Doyle WJ, Turner RB, Alper CM, Skoner DP. Childhood socioeconomic status and host resistance to infectious illness in adulthood. Psychosom Med. 2004 Jul-Aug;66(4):553-8. doi: 10.1097/01.psy.0000126200.05189.d3. PubMed 15272102 ↗
  • Miller GE, Chen E, Parker KJ. Psychological stress in childhood and susceptibility to the chronic diseases of aging: moving toward a model of behavioral and biological mechanisms. Psychol Bull. 2011 Nov;137(6):959-97. doi: 10.1037/a0024768. PubMed 21787044 ↗
  • Cole SW, Hawkley LC, Arevalo JM, Cacioppo JT. Transcript origin analysis identifies antigen-presenting cells as primary targets of socially regulated gene expression in leukocytes. Proc Natl Acad Sci U S A. 2011 Feb 15;108(7):3080-5. doi: 10.1073/pnas.1014218108. Epub 2011 Feb 7. PubMed 21300872 ↗
  • Kok BE, Fredrickson BL. Upward spirals of the heart: autonomic flexibility, as indexed by vagal tone, reciprocally and prospectively predicts positive emotions and social connectedness. Biol Psychol. 2010 Dec;85(3):432-6. doi: 10.1016/j.biopsycho.2010.09.005. Epub 2010 Sep 22. Erratum In: Biol Psychol. 2016 May;117:240. doi: 10.1016/j.biopsycho.2016.03.001. PubMed 20851735 ↗
  • West TN, Zhou J, Brantley MM, Kim SL, Brantley J, Salzberg S, Cole SW, Fredrickson BL. Effect of Mindfulness Versus Loving-kindness Training on Leukocyte Gene Expression in Midlife Adults Raised in Low-Socioeconomic Status Households. Mindfulness (N Y). 2022 May;13(5):1185-1196. doi: 10.1007/s12671-022-01857-z. Epub 2022 Mar 16. PubMed 36278141 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02400593
Lead sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Aging (NIA)
Responsible party
Barbara L. Fredrickson, PhD (Kenan Distinguished Professor, University of North Carolina, Chapel Hill) — Principal investigator
First posted
Mar 27, 2015
Start date
Aug 2015
Primary completion
May 2016
Completion
May 2016
Last update
Jul 15, 2016

Study contacts

Barbara L Fredrickson, PhD
principal investigator · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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