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Completed

NCT Number: NCT03056417

Impact of Lifestyle Changes on Telomeric Activity 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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio University

Athens, Ohio, 45701, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Complete Health Improvement Program

Behavioral

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.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Ohio University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 17, 2017
Registry last updated
Oct 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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