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CompletedNCT03056417Updated Oct 30, 2020

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

An interventional study of The Complete Health Improvement Program in Chronic Pain, sponsored by Ohio University. Completed at 1 site in United States. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-10-30.

Sponsored by Ohio University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
67
Allocation
Non-randomized
Ages
40 Years to 70 Years
Sex
All
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Study 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.

02

Conditions studied

  • Chronic Pain

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Keywords

  • chronic pain
  • telomere
  • telomerase
  • life style
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In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's enrollment of 67 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Ohio University is the lead sponsor of 64 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
67 participants (actual)

Study arms

  • Experimental
    Intervention

    Participants in the Complete Health Improvement Program.

    Behavioral: The Complete Health Improvement Program

  • No intervention
    No Change to Treatment

    Participants who choose not to participate in the Complete Health Improvement Program.

Interventions

  • BehavioralThe 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.

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What researchers measure

Primary outcomes

  1. Telomerase activity changes as a result of lifestyle change

    Assessed via peripheral blood mononuclear cells

    Time frame: Change from baseline telomerase at 3 months

  2. Subjective pain ratings as a function of positive lifestyle modifications

    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).

    Time frame: Change from baseline subjective pain at 3 months

Secondary outcomes

  1. Relative telomere length changes as a result of lifestyle change

    Assessed via whole blood samples

    Time frame: Change from baseline telomere length at 3 months

  2. Relative telomere length changes as a result of lifestyle change at 1-year follow-up

    Assessed via whole blood samples

    Time frame: Change from 3 month follow-up data of telomere length at 1-year

  3. Fasting glucose changes as a result of lifestyle change

    Assessed via whole blood samples

    Time frame: Change from baseline fasting glucose at 3 months

  4. Fasting glucose changes as a result of lifestyle change at 1-year follow-up

    Assessed via whole blood samples

    Time frame: Change from 3 month follow-up data of fasting glucose at 1-year

  5. Fasting lipid profile (i.e., HDL, LDL, triglycerides) modification as a result of lifestyle change

    Assessed via whole blood

    Time frame: change from baseline fasting lipids at 3 months

  6. Fasting lipid profile (i.e., HDL, LDL, triglycerides) modification as a result of lifestyle change at 1-year follow-up

    Assessed via whole blood

    Time frame: Change from 3 month follow-up data of fasting lipids at 1-year

  7. C-reactive protein changes as a result of lifestyle change

    Assessed via plasma

    Time frame: change from baseline C-reactive protein at 3 months

  8. C-reactive protein changes as a result of lifestyle change at 1-year follow-up

    Assessed via plasma

    Time frame: Change from 3 month follow-up data of C-reactive protein at 1-year

  9. Overall well-being changes as a result of lifestyle change

    The RAND-36 item short form survey. High score indicates more favorable health state. Minimum score 0 Maximum score 100.

    Time frame: change from baseline overall well-being at 3 months

  10. Overall well-being changes as a result of lifestyle change at 1-year follow-up

    The RAND-36 item short form survey. High score indicates more favorable health state. Minimum score 0 Maximum score 100.

    Time frame: Change from 3 month follow-up data of overall well-being at 1-year

  11. Perceived Stress changes as a result of lifestyle change

    The 14-item Perceived Stress Scale. Minimum score 0 Maximum score 40. Higher scores indicate greater perceived stress.

    Time frame: change from baseline perceived stress at 3 months

  12. Perceived Stress changes as a result of lifestyle change at 1-year follow-up

    The 14-item Perceived Stress Scale. Minimum score 0 Maximum score 40. Higher scores indicate greater perceived stress.

    Time frame: Change from 3 month follow-up data of perceived stress at 1-year

  13. Depressive symptom changes as a result of lifestyle change

    Center for Epidemiological Studies Depression Scale. Higher score indicates greater depressed mood. Minimum score 0 Maximum score 60.

    Time frame: change from baseline depressed mood at 3 months

  14. Depressive symptom changes as a result of lifestyle change at 1-year follow-up

    Center for Epidemiological Studies Depression Scale. Higher score indicates greater depressed mood. Minimum score 0 Maximum score 60.

    Time frame: Change from 3 month follow-up data of depressed mood at 1-year

  15. Perceived social support modification as a result of lifestyle change

    Multidimensional Scale of Perceived Social Support. Higher score indicates greater perceived social support. Minimum score 1 Maximum score 7.

    Time frame: change from baseline perceived social support at 3 months

  16. Perceived social support modification as a result of lifestyle change at 1-year follow-up

    Multidimensional Scale of Perceived Social Support. Higher score indicates greater perceived social support. Minimum score 1 Maximum score 7.

    Time frame: Change from 3 month follow-up data of perceived social support at 1-year

  17. Health-Promoting behavior change as a result of lifestyle modification

    Health-Promoting Lifestyle Profile II questionnaire. Higher score indicate greater health promotion. Minimum score 1 Maximum score 4.

    Time frame: change from baseline health promoting behavior at 3 months

  18. Health-Promoting behavior change as a result of lifestyle modification at 1-year follow-up

    Health-Promoting Lifestyle Profile II questionnaire. Higher score indicate greater health promotion. Minimum score 1 Maximum score 4.

    Time frame: Change from 3 month follow-up data of health promoting behavior at 1-year

  19. Telomerase activity changes as a result of lifestyle change at 1-year follow-up

    Assessed via peripheral blood mononuclear cells

    Time frame: Change from 3 month follow-up data of telomerase activity at 1-year

  20. Subjective pain ratings as a function of positive lifestyle modifications at 1-year follow-up

    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).

    Time frame: Change from 3 month follow-up data of subjective pain at 1-year

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Study locations

1 site
  • Ohio University
    Athens, Ohio 45701, United States
08

References and documents

Publications

  • Shcherbakova DM, Zvereva ME, Shpanchenko OV, Dontsova OA. [Telomerase: structure and properties of the enzyme, characteristics of the yeast telomerase]. Mol Biol (Mosk). 2006 Jul-Aug;40(4):580-94. Russian. PubMed 16913218 ↗
  • Li B, Comai L. Requirements for the nucleolytic processing of DNA ends by the Werner syndrome protein-Ku70/80 complex. J Biol Chem. 2001 Mar 30;276(13):9896-902. doi: 10.1074/jbc.M008575200. Epub 2001 Jan 4. PubMed 11152456 ↗
  • Drozek D, Diehl H, Nakazawa M, Kostohryz T, Morton D, Shubrook JH. Short-term effectiveness of a lifestyle intervention program for reducing selected chronic disease risk factors in individuals living in rural appalachia: a pilot cohort study. Adv Prev Med. 2014;2014:798184. doi: 10.1155/2014/798184. Epub 2014 Jan 16. PubMed 24527219 ↗
  • Hassett AL, Epel E, Clauw DJ, Harris RE, Harte SE, Kairys A, Buyske S, Williams DA. Pain is associated with short leukocyte telomere length in women with fibromyalgia. J Pain. 2012 Oct;13(10):959-69. doi: 10.1016/j.jpain.2012.07.003. PubMed 23031395 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03056417
Lead sponsor
Ohio University
Responsible party
Sponsor
First posted
Feb 17, 2017
Start date
Jan 10, 2017
Primary completion
May 2019
Completion
May 2019
Last update
Oct 30, 2020

Study contacts

Katrina Hamilton, M.S.
principal investigator · Ohio University
David Drozek, D.O.
study director · Ohio University
Peggy Zoccola, Ph.D.
study chair · Ohio University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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