Skip to content

Health Experiences & Early Life Disadvantages

An Affective Intervention to Reverse the Biological Residue of Low Childhood SES

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02400593
Acronym
HEELD
Enrollment
113
Registered
2015-03-27
Start date
2015-08-31
Completion date
2016-05-31
Last updated
2016-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Stress, Early Life Adversity

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.

Interventions

BEHAVIORALMeditation Workshop

Six weeks of formal instruction in Lovingkindness or Mindfulness meditation.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
35 Years to 64 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in meditation time (Self-reported meditation time recorded daily)Weeks 3, 4, 5, 6, 7, 8, 9 ,10, 11, 12Self-reported meditation time recorded daily.

Secondary

MeasureTime frameDescription
Leukocyte basal gene expression (evaluated through blood samples)Week 0, Week 12Gene expression evaluated through blood samples.
Levels of mistrust (Self-report questionnaire measure of hostility using 9-item Cooke-Medley scale)Week 0, Week 12Self-report questionnaire measure of hostility using 9-item Cooke-Medley scale.
Temporal Discounting (Monetary choice questionnaire to assess impulsive decision-making)Week 0, Week 12Monetary choice questionnaire to assess impulsive decision-making.
Cardiac vagal tone (Respiration and echocardiogram measured with respiration band and 2-lead electrode placement)Week 0, Week 12Respiration and echocardiogram measured with respiration band and 2-lead electrode placement, respectively. Three-minute spontaneous breath followed by five minutes of paced breathing intervals.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026