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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: The Complete Health Improvement Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants in the Complete Health Improvement Program. | Behavioral: The Complete Health Improvement Program<br>* 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.<br>|
| No Intervention: No Change to Treatment<br>Participants who choose not to participate in the Complete Health Improvement Program. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Telomerase activity changes as a result of lifestyle change | Assessed via peripheral blood mononuclear cells | Change from baseline telomerase at 3 months | 
| 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). | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic pain, telomere, telomerase, life style