Health Experiences & Early Life Disadvantages (HEELD)

July 14, 2016 updated by: Barbara L. Fredrickson, PhD, University of North Carolina, Chapel Hill

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • UNC PEP Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lovingkindness
A six-week formal meditation workshop for 1 hour per week.
Behavioral: Meditation Workshop
Six weeks of formal instruction in Lovingkindness or Mindfulness meditation.
Placebo Comparator: Mindfulness
A six-week formal meditation workshop for 1 hour per week.
Behavioral: Meditation Workshop
Six weeks of formal instruction in Lovingkindness or Mindfulness meditation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Weeks 3, 4, 5, 6, 7, 8, 9 ,10, 11, 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leukocyte basal gene expression (evaluated through blood samples)
Time Frame: Week 0, Week 12
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)
Time Frame: Week 0, Week 12
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)
Time Frame: Week 0, Week 12
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)
Time Frame: Week 0, Week 12
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.
Week 0, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Barbara L Fredrickson, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

March 23, 2015

First Submitted That Met QC Criteria

March 26, 2015

First Posted (Estimate)

March 27, 2015

Study Record Updates

Last Update Posted (Estimate)

July 15, 2016

Last Update Submitted That Met QC Criteria

July 14, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 14-1938
  • R01AG048811 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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