Impact of Lifestyle Changes on Telomeric Activity in Patients With Chronic Pain

October 27, 2020 updated by: Ohio University

Impact of Lifestyle Changes Via the Complete Health Improvement Program on Telomerase Activity and Telomere Length in Patients With Chronic Pain

The current project will use the Complete Health Improvement Program (CHIP) as an intervention for patients with chronic pain. CHIP is a nationally recognized program that encourages a diet of whole plant-based foods, moderate exercise, stress reduction, and social support. Patients with chronic pain who enroll in CHIP classes will be monitored and compared to patients with chronic pain who are not enrolled in CHIP classes. It is hypothesized that patients who complete CHIP will have increased telomerase activity and longer relative telomere length at follow-up when compared to those who do not enroll in the program. Chromosomes consist of DNA that contains the genetic makeup of an individual; and telomeres are the caps on these chromosomes that protect them from damage. Telomere shortening occurs normally with aging and once they are too short to replicate cellular death occurs. Telomerase is a ribonucleic protein that counterbalances this shortening by extending the ends of chromosomes. Research has shown that patients with chronic pain may have shorter telomeres relative to others of the same age. This study will investigate this association further.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
67

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Ohio
      • Athens, Ohio, United States, 45701
        • Ohio University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 40-70 years old
  • Physician confirmed chronic pain diagnosis for at least 6 months

Exclusion Criteria:

  • Pregnancy
  • Physical or mental condition that limits ability to provide consent or answer questionnaires

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Participants in the Complete Health Improvement Program.
Behavioral: The Complete Health Improvement Program
The Complete Health Improvement Program is a nationally recognized program that encourages a diet of whole plant based foods, moderate exercise, stress reduction, and social support.
No Intervention: No Change to Treatment
Participants who choose not to participate in the Complete Health Improvement Program.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Telomerase activity changes as a result of lifestyle change
Time Frame: Change from baseline telomerase at 3 months
Assessed via peripheral blood mononuclear cells
Change from baseline telomerase at 3 months
Subjective pain ratings as a function of positive lifestyle modifications
Time Frame: Change from baseline subjective pain at 3 months
Assessed via the Brief Pain Inventory - Short Form. Measures pain intensity from 0 to 10, 10 being pain as bad as you can imagine. Also measures the extent to which pain interferes with daily functioning (0 - 10 possible, with 10 indicating completely interferes).
Change from baseline subjective pain at 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Relative telomere length changes as a result of lifestyle change
Time Frame: Change from baseline telomere length at 3 months
Assessed via whole blood samples
Change from baseline telomere length at 3 months
Relative telomere length changes as a result of lifestyle change at 1-year follow-up
Time Frame: Change from 3 month follow-up data of telomere length at 1-year
Assessed via whole blood samples
Change from 3 month follow-up data of telomere length at 1-year
Fasting glucose changes as a result of lifestyle change
Time Frame: Change from baseline fasting glucose at 3 months
Assessed via whole blood samples
Change from baseline fasting glucose at 3 months
Fasting glucose changes as a result of lifestyle change at 1-year follow-up
Time Frame: Change from 3 month follow-up data of fasting glucose at 1-year
Assessed via whole blood samples
Change from 3 month follow-up data of fasting glucose at 1-year
Fasting lipid profile (i.e., HDL, LDL, triglycerides) modification as a result of lifestyle change
Time Frame: change from baseline fasting lipids at 3 months
Assessed via whole blood
change from baseline fasting lipids at 3 months
Fasting lipid profile (i.e., HDL, LDL, triglycerides) modification as a result of lifestyle change at 1-year follow-up
Time Frame: Change from 3 month follow-up data of fasting lipids at 1-year
Assessed via whole blood
Change from 3 month follow-up data of fasting lipids at 1-year
C-reactive protein changes as a result of lifestyle change
Time Frame: change from baseline C-reactive protein at 3 months
Assessed via plasma
change from baseline C-reactive protein at 3 months
C-reactive protein changes as a result of lifestyle change at 1-year follow-up
Time Frame: Change from 3 month follow-up data of C-reactive protein at 1-year
Assessed via plasma
Change from 3 month follow-up data of C-reactive protein at 1-year
Overall well-being changes as a result of lifestyle change
Time Frame: change from baseline overall well-being at 3 months
The RAND-36 item short form survey. High score indicates more favorable health state. Minimum score 0 Maximum score 100.
change from baseline overall well-being at 3 months
Overall well-being changes as a result of lifestyle change at 1-year follow-up
Time Frame: Change from 3 month follow-up data of overall well-being at 1-year
The RAND-36 item short form survey. High score indicates more favorable health state. Minimum score 0 Maximum score 100.
Change from 3 month follow-up data of overall well-being at 1-year
Perceived Stress changes as a result of lifestyle change
Time Frame: change from baseline perceived stress at 3 months
The 14-item Perceived Stress Scale. Minimum score 0 Maximum score 40. Higher scores indicate greater perceived stress.
change from baseline perceived stress at 3 months
Perceived Stress changes as a result of lifestyle change at 1-year follow-up
Time Frame: Change from 3 month follow-up data of perceived stress at 1-year
The 14-item Perceived Stress Scale. Minimum score 0 Maximum score 40. Higher scores indicate greater perceived stress.
Change from 3 month follow-up data of perceived stress at 1-year
Depressive symptom changes as a result of lifestyle change
Time Frame: change from baseline depressed mood at 3 months
Center for Epidemiological Studies Depression Scale. Higher score indicates greater depressed mood. Minimum score 0 Maximum score 60.
change from baseline depressed mood at 3 months
Depressive symptom changes as a result of lifestyle change at 1-year follow-up
Time Frame: Change from 3 month follow-up data of depressed mood at 1-year
Center for Epidemiological Studies Depression Scale. Higher score indicates greater depressed mood. Minimum score 0 Maximum score 60.
Change from 3 month follow-up data of depressed mood at 1-year
Perceived social support modification as a result of lifestyle change
Time Frame: change from baseline perceived social support at 3 months
Multidimensional Scale of Perceived Social Support. Higher score indicates greater perceived social support. Minimum score 1 Maximum score 7.
change from baseline perceived social support at 3 months
Perceived social support modification as a result of lifestyle change at 1-year follow-up
Time Frame: Change from 3 month follow-up data of perceived social support at 1-year
Multidimensional Scale of Perceived Social Support. Higher score indicates greater perceived social support. Minimum score 1 Maximum score 7.
Change from 3 month follow-up data of perceived social support at 1-year
Health-Promoting behavior change as a result of lifestyle modification
Time Frame: change from baseline health promoting behavior at 3 months
Health-Promoting Lifestyle Profile II questionnaire. Higher score indicate greater health promotion. Minimum score 1 Maximum score 4.
change from baseline health promoting behavior at 3 months
Health-Promoting behavior change as a result of lifestyle modification at 1-year follow-up
Time Frame: Change from 3 month follow-up data of health promoting behavior at 1-year
Health-Promoting Lifestyle Profile II questionnaire. Higher score indicate greater health promotion. Minimum score 1 Maximum score 4.
Change from 3 month follow-up data of health promoting behavior at 1-year
Telomerase activity changes as a result of lifestyle change at 1-year follow-up
Time Frame: Change from 3 month follow-up data of telomerase activity at 1-year
Assessed via peripheral blood mononuclear cells
Change from 3 month follow-up data of telomerase activity at 1-year
Subjective pain ratings as a function of positive lifestyle modifications at 1-year follow-up
Time Frame: Change from 3 month follow-up data of subjective pain at 1-year
Assessed via the Brief Pain Inventory - Short Form. Measures pain intensity from 0 to 10, 10 being pain as bad as you can imagine. Also measures the extent to which pain interferes with daily functioning (0 - 10 possible, with 10 indicating completely interferes).
Change from 3 month follow-up data of subjective pain at 1-year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katrina Hamilton, M.S., Ohio University
  • Study Director: David Drozek, D.O., Ohio University
  • Study Chair: Peggy Zoccola, Ph.D., Ohio University

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14X145

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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