Impact of Lifestyle Changes on Telomeric Activity in Patients With Chronic Pain
- Conditions
- Chronic Pain
- Interventions
- Behavioral: The Complete Health Improvement Program
- Registration Number
- NCT03056417
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
- 40-70 years old
- Physician confirmed chronic pain diagnosis for at least 6 months
- Pregnancy
- Physical or mental condition that limits ability to provide consent or answer questionnaires
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention The Complete Health Improvement Program Participants in the Complete Health Improvement Program.
- Primary Outcome Measures
Name Time Method Telomerase activity changes as a result of lifestyle change Change from baseline telomerase at 3 months Assessed via peripheral blood mononuclear cells
Subjective pain ratings as a function of positive lifestyle modifications 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
Name Time Method C-reactive protein changes as a result of lifestyle change change from baseline C-reactive protein at 3 months Assessed via plasma
Fasting lipid profile (i.e., HDL, LDL, triglycerides) modification as a result of lifestyle change change from baseline fasting lipids at 3 months Assessed via whole blood
Overall well-being changes as a result of lifestyle change 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.
Depressive symptom changes as a result of lifestyle change 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.
Relative telomere length changes as a result of lifestyle change Change from baseline telomere length at 3 months Assessed via whole blood samples
Fasting glucose changes as a result of lifestyle change at 1-year follow-up 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 at 1-year follow-up Change from 3 month follow-up data of fasting lipids at 1-year Assessed via whole blood
Perceived Stress changes as a result of lifestyle change 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 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 at 1-year follow-up 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 at 1-year follow-up 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 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.
Telomerase activity changes as a result of lifestyle change at 1-year follow-up Change from 3 month follow-up data of telomerase activity at 1-year Assessed via peripheral blood mononuclear cells
Relative telomere length changes as a result of lifestyle change at 1-year follow-up Change from 3 month follow-up data of telomere length at 1-year Assessed via whole blood samples
C-reactive protein changes as a result of lifestyle change at 1-year follow-up 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 at 1-year follow-up 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.
Fasting glucose changes as a result of lifestyle change Change from baseline fasting glucose at 3 months Assessed via whole blood samples
Perceived social support modification as a result of lifestyle change 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.
Health-Promoting behavior change as a result of lifestyle modification at 1-year follow-up 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.
Subjective pain ratings as a function of positive lifestyle modifications at 1-year follow-up 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).
Trial Locations
- Locations (1)
Ohio University
🇺🇸Athens, Ohio, United States