Health Experiences & Early Life Disadvantages

NCT ID: NCT02400593

Last Updated: 2016-07-15

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Early Life Adversity Chronic Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Lovingkindness

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

Group Type EXPERIMENTAL

Meditation Workshop

Intervention Type BEHAVIORAL

Six weeks of formal instruction in Lovingkindness or Mindfulness meditation.

Mindfulness

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

Group Type PLACEBO_COMPARATOR

Meditation Workshop

Intervention Type BEHAVIORAL

Six weeks of formal instruction in Lovingkindness or Mindfulness meditation.

Interventions

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Meditation Workshop

Six weeks of formal instruction in Lovingkindness or Mindfulness meditation.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

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)
Minimum Eligible Age

35 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Barbara L. Fredrickson, PhD

Kenan Distinguished Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbara L Fredrickson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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UNC PEP Lab

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19617551 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15272102 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21787044 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21300872 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20851735 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36278141 (View on PubMed)

Other Identifiers

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R01AG048811

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14-1938

Identifier Type: -

Identifier Source: org_study_id

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