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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

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
    • 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

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
Intervention / Treatment
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

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

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

Ohio University

Investigators

  • 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)

January 10, 2017

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

February 13, 2017

First Submitted That Met QC Criteria

February 14, 2017

First Posted (Actual)

February 17, 2017

Study Record Updates

Last Update Posted (Actual)

October 30, 2020

Last Update Submitted That Met QC Criteria

October 27, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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