Early Life AdversityHEELDNCT02400593
Health Experiences & Early Life Disadvantages
A study testing Meditation Workshop in people with Early Life Adversity and Chronic Stress, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Life Adversity, Chronic Stress
- What is being tested?
- Meditation Workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- fluent in written and spoken English
- have daily access to internet and a computer
Who cannot join
- engaged in regular meditation practice, either recently or in the past
- previously participated in a meditation study
- have allergies to adhesive materials (includes latex)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Affective Intervention to Reverse the Biological Residue of Low Childhood SES
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.
- Conditions
- Early Life Adversity, Chronic Stress
- Being tested
- Meditation Workshop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meditation WorkshopBehavioural
Six weeks of formal instruction in Lovingkindness or Mindfulness meditation.
| Study group | Role | What they receive |
|---|---|---|
| Lovingkindness | Experimental | A six-week formal meditation workshop for 1 hour per week. Receives: Behavioral: Meditation Workshop |
| Mindfulness | Placebo comparator | A six-week formal meditation workshop for 1 hour per week. Receives: Behavioral: Meditation Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in meditation time (Self-reported meditation time recorded daily)
Self-reported meditation time recorded daily.
Measured: Weeks 3, 4, 5, 6, 7, 8, 9 ,10, 11, 12
Secondary outcomes (4)
Leukocyte basal gene expression (evaluated through blood samples)
Gene expression evaluated through blood samples.
Measured: Week 0, Week 12
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.
Measured: Week 0, Week 12
Temporal Discounting (Monetary choice questionnaire to assess impulsive decision-making)
Monetary choice questionnaire to assess impulsive decision-making.
Measured: Week 0, Week 12
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.
Measured: Week 0, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Early Life AdversityStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Barbara L. Fredrickson, PhD, University of North Carolina, Chapel Hill
- Investigators
- Barbara L Fredrickson, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400593
- Sponsor's protocol ID
- 14-1938
- Other IDs
- R01AG048811
- Acronym
- HEELD
- Status last verified
- Jul 2016
- First submitted
- 23 Mar 2015
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
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 19617551Cohen 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 15272102Miller 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 21787044Cole 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 21300872Kok 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.
PubMed 20851735West 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Affective Intervention to Reverse the Biological Residue of Low Childhood SES
- ClinicalTrials.gov ID
- NCT02400593
- Acronym / sponsor ID
- HEELD / 14-1938
- Conditions
- Early Life Adversity, Chronic Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Aug 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lovingkindness | Experimental | Behavioral: Meditation WorkshopA six-week formal meditation workshop for 1 hour per week. |
| Mindfulness | Placebo comparator | Behavioral: Meditation WorkshopA six-week formal meditation workshop for 1 hour per week. |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- fluent in written and spoken English
- have daily access to internet and a computer
Key exclusion criteria (3 listed)
- engaged in regular meditation practice, either recently or in the past
- previously participated in a meditation study
- have allergies to adhesive materials (includes latex)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meditation WorkshopSix weeks of formal instruction in Lovingkindness or Mindfulness meditation. | Behavioural | Lovingkindness, Mindfulness |
Primary outcome
Change in meditation time (Self-reported meditation time recorded daily)
Time frame: Weeks 3, 4, 5, 6, 7, 8, 9 ,10, 11, 12
Self-reported meditation time recorded daily.
4 secondary outcomes
Leukocyte basal gene expression (evaluated through blood samples)
Time frame: Week 0, Week 12
Levels of mistrust (Self-report questionnaire measure of hostility using 9-item Cooke-Medley scale)
Time frame: Week 0, Week 12
Temporal Discounting (Monetary choice questionnaire to assess impulsive decision-making)
Time frame: Week 0, Week 12
Cardiac vagal tone (Respiration and echocardiogram measured with respiration band and 2-lead electrode placement)
Time frame: Week 0, Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2016.
- Background: PubMed 19617551Miller 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.
- Background: PubMed 15272102Cohen 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.
- Background: PubMed 21787044Miller 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.
- Background: PubMed 21300872Cole 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.
- Background: PubMed 20851735Kok 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.
- Derived from this study: PubMed 36278141West 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara L Fredrickson, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation Workshop in people with Early Life Adversity and Chronic Stress, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in meditation time (Self-reported meditation time recorded daily) (time frame: Weeks 3, 4, 5, 6, 7, 8, 9 ,10, 11, 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02400593, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2016.