Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056417
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : October 30, 2020
Sponsor:
Information provided by (Responsible Party):
Ohio University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: The Complete Health Improvement Program Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of Lifestyle Changes Via the Complete Health Improvement Program on Telomerase Activity and Telomere Length in Patients With Chronic Pain
Actual Study Start Date : January 10, 2017
Actual Primary Completion Date : May 2019
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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.



Primary Outcome Measures :
  1. Telomerase activity changes as a result of lifestyle change [ Time Frame: Change from baseline telomerase at 3 months ]
    Assessed via peripheral blood mononuclear cells

  2. 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).


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Fasting glucose changes as a result of lifestyle change [ Time Frame: Change from baseline fasting glucose at 3 months ]
    Assessed via whole blood samples

  4. 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

  5. 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

  6. 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

  7. C-reactive protein changes as a result of lifestyle change [ Time Frame: change from baseline C-reactive protein at 3 months ]
    Assessed via plasma

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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

  20. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056417


Locations
Layout table for location information
United States, Ohio
Ohio University
Athens, Ohio, United States, 45701
Sponsors and Collaborators
Ohio University
Investigators
Layout table for investigator information
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:
Layout table for additonal information
Responsible Party: Ohio University
ClinicalTrials.gov Identifier: NCT03056417    
Other Study ID Numbers: 14X145
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ohio University:
chronic pain
telomere
telomerase
life style
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations