The present study explored the effects of the implementation of the Pythagorean Self Awareness Intervention (PSAI) on the dynamics of stress-related aging factors of immune cells in healthy volunteers and a cohort patients with type 2 diabetes mellitus . The primary aim was to evaluate the effectiveness of PSAI on two key biomarkers of biological age, telomere length and proteasome levels, indicative of the crosstalk between cellular oxidative status and replicative potential, with respect to metabolic, hormonal and mental status changes. Secondary aims of this study included reduction of depression, perceived stress, anxiety and the establishment of lifestyle changes to enhance the quality of everyday life, including better quality of sleep, eating behaviours and an overall healthier status.
Study design This non randomized non blinded parallel trial was conducted at the Laiko Hospital of Athens, Diabetes Centre, First Department of Propaedeutic Internal Medicine of Attica, Greece, from 4.10.2018 to 26.11.2019. The study protocol was approved by the Ethics Committee of the Laiko Hospital (protocol number 5134/5-4-19) and was in accordance with the declaration of Helsinki. All participants were enlisted in the study only after being fully informed by the researcher about the aims and procedures of the research and submitting written consent. Procedures Patients eligible for the above mentioned criteria were randomized in two groups: the group of healthy adult volunteers, and adults with type 2 diabetes who attended the outpatient diabetes clinic. This study was non-blinded, as patients and researchers were aware of the group assignment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
The PSAI is a mental, stress-management technique that promotes self-awareness, cognitive reconstruction and self-improvement based on the Golden Verses moral framework of the ancient Greek philosopher Pythagoras. The individual must practice the technique twice daily( at bed-time and in the morning, every day, at home) and through a 3-stage internal dialogue (recall of daily events, inspection of related thoughts and emotions and self-appraisal)is encouraged to detect wrong choices and unhealthy behaviours and initiate self-correction towards a healthier lifestyle.
General University Laiko Hospital
Athens, Greece
Determination of telomeres' length
Extracted DNA from Peripheral blood mononuclear cells isolated from total blood
Time frame: 2 months
Determination of telomeres' length
Extracted DNA from Peripheral blood mononuclear cells isolated from total blood
Time frame: 6 months
Determination of 20S proteasome concentration
Protein extracts from Peripheral blood mononuclear cells isolated from total blood
Time frame: 6 months
Healthy Lifestyle and Personal Control Questionnaire
Self-report questionnaire for the evaluation of a healthy lifestyle with the instrument Healthy Lifestyle and Personal Control Questionnaire that explores five dimensions of lifestyle (Organized Physical Exercise, Social Support and Mental Control, Daily Routine, Dietary Harm Avoidance, Dietary Healthy Habits).Scores range from 26 to 104 with higher scores indicating a healthier lifestyle.
Time frame: 6 months
Glycosylated haemoglobin
total blood
Time frame: 6 months
Hair cortisol concentration
Hair specimens from the posterior vertex of the scalp, three cm proximal to scalp
Time frame: 6 months
Total Body Water
Total Body Water will be reported in percent and it will be measured by the device TANITA BC418 (Tanita Cooperation, Tokyo, Japan),
Time frame: 6 months
Fat Free Mass
Fat Free Mass will be reported in kilograms,and it will be measured by the device TANITA BC418 (Tanita Cooperation, Tokyo, Japan),
Time frame: 6 months
Fat Mass
Fat Mass will be reported in percentage and it will be measured by the device TANITA BC418 (Tanita Cooperation, Tokyo, Japan),
Time frame: 6 months
Visceral fat
Visceral fat will be reported in cm \^2 and it will be measured by the device TANITA BC418 (Tanita Cooperation, Tokyo, Japan)
Time frame: 6 months
Trunk fat
Trunk fat will be reported in percentage and it will be measured by the device TANITA BC418 (Tanita Cooperation, Tokyo, Japan)
Time frame: 6 months
Body Mass Index
Weight and height will be combined to report BMI in kg/m\^2
Time frame: 6 months
Depression Anxiety Stress Scale
Self-referential symptoms of depression, anxiety and stress with the instrument Depression-Anxiety-Stress Scale-21 Three scores(Depression, Anxiety, Stress). Depression score ranging from 0 to 42, Anxiety score ranging from 0-42, Stress score ranging from 0-42. We expect reduction.
Time frame: 6 months
Perceived Stress Scale
Evaluation with the self-referential instrument the Perceived Stress Scale. Score ranging from 0 to 56 with higher score indicating higher perceived stress. We expect reduction.
Time frame: 6 months
Self-referential quality of sleep
Evaluation of sleep quality with the instrument Greek version Pittburgh Sleep Quality Index. Score ranging from 0 to 21. Score higher than 5 indicates poor sleep quality. We expect reduction.
Time frame: 6 months
Self-referential Internal Health Locus of Control
Evaluation of internal health locus with the instrument Health Locus of Control. Score ranging from 6 to 36 with higher scores indicating higher self-control over the individual's health. We expect increase.
Time frame: 6 months
Self-referential External and chance Health Locus of Control
Evaluation of External health locus of control and chance, with the instrument Health Locus of Control. Score ranging from 6 to 36 for each dimension. Higher score means that the individual perceives that his/her health is controlled by external factors and chance.We expect reduction.
Time frame: 6 months
Self-referential health locus of control Powerful others
Evaluation of health locus of control for Powerful others with the instrument Health Locus of Control. Score ranging from 6 to 36.Higher score means that the individual perceives that his/her health is controlled by powerful others such as health personnel.We expect reduction.
Time frame: 6 months
Evaluation of verbal memory
Assessment of verbal memory with the cognitive test California Verbal Learning test. Score ranging from 0 to 90 with higher score indicating better verbal memory. We expect increase.
Time frame: 6 months
Evaluation of visuospatial memory
Assessment of visuospatial memory with the cognitive test Brief Visuospatial Memory test-Revised. Score ranging from 0 to 36 with higher score indicating better visuospatial memory.We expect increase.
Time frame: 6 months
Evaluation of speed processing information
Assessment of speed processing of information with the cognitive test Symbol Digits Modality test. Score ranging from 0 to 95 with higher score indicating higher speed processing of information.We expect increase.
Time frame: 6 months
Fatigue
Assessment of physical, mental and brain fatigue with a visual analogue scale with minimum as 0 indicating no fatigue at all and maximum 10 indicating high degree of fatigue. We expect reduction.
Time frame: 6 months
Perimeter of the waist
Perimeter will be reported in centimeters
Time frame: 6 months
Perimeter of the neck
Perimeter will be reported in centimeters
Time frame: 6 months
Perimeter of the hips
Perimeter will be reported in centimeters
Time frame: 6 months
Extracellular water
Extracellular water will be reported in percentage and with be assessed by a device of bioelectrical impedance technology by BIOTEKNA©, Biomedical Technologies, Venice, Italy
Time frame: 6 months
Intracellular water
Intracellular water will be reported in percentage and it will be measured by a device of bioelectrical impedance technology by BIOTEKNA©, Biomedical Technologies, Venice, Italy
Time frame: 6 months
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