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

• ClinicalTrials.gov Identifier: NCT03056417
• Recruitment Status: Completed
• First Posted: February 17, 2017
• Last Update Posted: October 30, 2020
• Sponsor: Ohio University
• Information provided by (Responsible Party): Ohio University

Tracking Information

• First Submitted Date: February 13, 2017
• First Posted Date: February 17, 2017
• Last Update Posted Date: October 30, 2020
• Actual Study Start Date: January 10, 2017
• Actual Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 27, 2020)

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

Original Primary Outcome Measures (submitted: February 14, 2017)

• Telomerase activity as a result of lifestyle change [ Time Frame: 3 months ]
  Assessed via peripheral blood mononuclear cells
• Subjective pain ratings as a function of positive lifestyle modifications [ Time Frame: 3 months ]
  Assessed via the Brief Pain Inventory - Short Form

Current Secondary Outcome Measures (submitted: October 27, 2020)

• 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
• 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
• Fasting glucose changes as a result of lifestyle change [ Time Frame: Change from baseline fasting glucose at 3 months ]
  Assessed via whole blood samples
• 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
• 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
• 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
• C-reactive protein changes as a result of lifestyle change [ Time Frame: change from baseline C-reactive protein at 3 months ]
  Assessed via plasma
• 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
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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
• 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).

Original Secondary Outcome Measures (submitted: February 14, 2017)

• Telomere length as a result of lifestyle change [ Time Frame: 3 months ]
  Assessed via whole blood samples
• Fasting glucose [ Time Frame: 3 months ]
  Assessed via whole blood samples
• Fasting lipid profile [ Time Frame: 3 months ]
  Assessed via whole blood
• C-reactive protein [ Time Frame: baseline and 3 months ]
  Assessed via plasma
• Overall well-being [ Time Frame: 3 months ]
  RAND-36
• Perceived Stress [ Time Frame: 3 months ]
  Perceived Stress Scale
• Depressive symptoms [ Time Frame: 3 months ]
  Center for Epidemiological Studies Depression Scale
• Perceived social support [ Time Frame: 3 months ]
  Multidimensional Scale of Perceived Social Support
• Health-Promoting Lifestyle Profile II questionnaire [ Time Frame: 3 months ]
  This questionnaire is a self-report of health-promoting lifestyle habits. Subscales include Self-Actualization, Health Responsibility, Physical activity, Nutrition, Interpersonal Support, and Stress Management.habits. Subscales include Self-Actualization, Health Responsibility, Physical activity, Nutrition, Interpersonal Support, and Stress Management.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Impact of Lifestyle Changes on Telomeric Activity in Patients With Chronic Pain
• Official Title: Impact of Lifestyle Changes Via the Complete Health Improvement Program on Telomerase Activity and Telomere Length in Patients With Chronic Pain
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Chronic Pain

Intervention

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.

Study Arms

• Experimental: Intervention
  Participants in the Complete Health Improvement Program.
  Intervention: Behavioral: The Complete Health Improvement Program
• No Intervention: No Change to Treatment
  Participants who choose not to participate in the Complete Health Improvement Program.

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. Review. Russian.
• 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. Epub 2001 Jan 4.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 27, 2020): 67
• Original Estimated Enrollment (submitted: February 14, 2017): 60
• Actual Study Completion Date: May 2019
• Actual Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03056417
• Other Study ID Numbers: 14X145
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Ohio University
• Study Sponsor: Ohio University
• Collaborators: Not Provided

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

• PRS Account: Ohio University
• Verification Date: September 2020