Impact of Lifestyle Changes on Telomeric Activity in Patients With Chronic Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03056417|
Recruitment Status : Enrolling by invitation
First Posted : February 17, 2017
Last Update Posted : February 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Behavioral: The Complete Health Improvement Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Impact of Lifestyle Changes Via the Complete Health Improvement Program on Telomerase Activity and Telomere Length in Patients With Chronic Pain|
|Actual Study Start Date :||January 10, 2017|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||December 2018|
Participants in the Complete Health Improvement Program.
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.
No Intervention: Control
Participants who choose not to participate in the Complete Health Improvement Program.
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056417
|United States, Ohio|
|Athens, Ohio, United States, 45701|
|Principal Investigator:||Katrina Hamilton, B.A.||Ohio University|
|Study Director:||David Drozek, D.O.||Ohio University|
|Study Chair:||Peggy Zoccola, Ph.D.||Ohio University|