Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-01-01 @ 5:56 AM
Study NCT ID:
NCT02400593
Status:
COMPLETED
Last Update Posted:
2016-07-15
First Post:
2015-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health Experiences & Early Life Disadvantages
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-14', 'studyFirstSubmitDate': '2015-03-23', 'studyFirstSubmitQcDate': '2015-03-26', 'lastUpdatePostDateStruct': {'date': '2016-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in meditation time (Self-reported meditation time recorded daily)', 'timeFrame': 'Weeks 3, 4, 5, 6, 7, 8, 9 ,10, 11, 12', 'description': 'Self-reported meditation time recorded daily.'}], 'secondaryOutcomes': [{'measure': 'Leukocyte basal gene expression (evaluated through blood samples)', 'timeFrame': 'Week 0, Week 12', 'description': 'Gene expression evaluated through blood samples.'}, {'measure': 'Levels of mistrust (Self-report questionnaire measure of hostility using 9-item Cooke-Medley scale)', 'timeFrame': 'Week 0, Week 12', 'description': 'Self-report questionnaire measure of hostility using 9-item Cooke-Medley scale.'}, {'measure': 'Temporal Discounting (Monetary choice questionnaire to assess impulsive decision-making)', 'timeFrame': 'Week 0, Week 12', 'description': 'Monetary choice questionnaire to assess impulsive decision-making.'}, {'measure': 'Cardiac vagal tone (Respiration and echocardiogram measured with respiration band and 2-lead electrode placement)', 'timeFrame': 'Week 0, Week 12', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Early Life Adversity', 'Chronic Stress']}, 'referencesModule': {'references': [{'pmid': '19617551', 'type': 'BACKGROUND', 'citation': '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': '15272102', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21787044', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21300872', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20851735', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '36278141', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nParticipants 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.\n\nAll surveys and questionnaires inquire about participants' current demographics, family history, perceptions about life and well-being, physical health, and monetary choices."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* fluent in written and spoken English\n* have daily access to internet and a computer\n\nExclusion Criteria:\n\n* engaged in regular meditation practice, either recently or in the past\n* previously participated in a meditation study\n* have allergies to adhesive materials (includes latex)'}, 'identificationModule': {'nctId': 'NCT02400593', 'acronym': 'HEELD', 'briefTitle': 'Health Experiences & Early Life Disadvantages', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'An Affective Intervention to Reverse the Biological Residue of Low Childhood SES', 'orgStudyIdInfo': {'id': '14-1938'}, 'secondaryIdInfos': [{'id': 'R01AG048811', 'link': 'https://reporter.nih.gov/quickSearch/R01AG048811', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lovingkindness', 'description': 'A six-week formal meditation workshop for 1 hour per week.', 'interventionNames': ['Behavioral: Meditation Workshop']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Mindfulness', 'description': 'A six-week formal meditation workshop for 1 hour per week.', 'interventionNames': ['Behavioral: Meditation Workshop']}], 'interventions': [{'name': 'Meditation Workshop', 'type': 'BEHAVIORAL', 'description': 'Six weeks of formal instruction in Lovingkindness or Mindfulness meditation.', 'armGroupLabels': ['Lovingkindness', 'Mindfulness']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC PEP Lab', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Barbara L Fredrickson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Kenan Distinguished Professor', 'investigatorFullName': 'Barbara L. Fredrickson, PhD', 'investigatorAffiliation': 'University of North Carolina, Chapel Hill'}}}}