Health Experiences & Early Life Disadvantages
HEELD
An Affective Intervention to Reverse the Biological Residue of Low Childhood SES
2 other identifiers
interventional
113
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2015
CompletedFirst Posted
Study publicly available on registry
March 27, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJuly 15, 2016
July 1, 2016
9 months
March 23, 2015
July 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in meditation time (Self-reported meditation time recorded daily)
Self-reported meditation time recorded daily.
Weeks 3, 4, 5, 6, 7, 8, 9 ,10, 11, 12
Secondary Outcomes (4)
Leukocyte basal gene expression (evaluated through blood samples)
Week 0, Week 12
Levels of mistrust (Self-report questionnaire measure of hostility using 9-item Cooke-Medley scale)
Week 0, Week 12
Temporal Discounting (Monetary choice questionnaire to assess impulsive decision-making)
Week 0, Week 12
Cardiac vagal tone (Respiration and echocardiogram measured with respiration band and 2-lead electrode placement)
Week 0, Week 12
Study Arms (2)
Lovingkindness
EXPERIMENTALA six-week formal meditation workshop for 1 hour per week.
Mindfulness
PLACEBO COMPARATORA six-week formal meditation workshop for 1 hour per week.
Interventions
Six weeks of formal instruction in Lovingkindness or Mindfulness meditation.
Eligibility Criteria
You may qualify if:
- fluent in written and spoken English
- have daily access to internet and a computer
You may not qualify if:
- engaged in regular meditation practice, either recently or in the past
- previously participated in a meditation study
- have allergies to adhesive materials (includes latex)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UNC PEP Lab
Chapel Hill, North Carolina, 27514, United States
Related Publications (6)
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.
PMID: 19617551BACKGROUNDCohen 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.
PMID: 15272102BACKGROUNDMiller 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.
PMID: 21787044BACKGROUNDCole 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.
PMID: 21300872BACKGROUNDKok 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.
PMID: 20851735BACKGROUNDWest 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.
PMID: 36278141DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara L Fredrickson, PhD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Kenan Distinguished Professor
Study Record Dates
First Submitted
March 23, 2015
First Posted
March 27, 2015
Study Start
August 1, 2015
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
July 15, 2016
Record last verified: 2016-07