Healthy Volunteers OnlyPSAINCT06671301
The Impact of Lifestyle Medicine on the Sense Of Coherence and Biological Age in a Community Sample
A study testing PSAI in people with Healthy Volunteers Only and Healthy Adults, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
This two-arm, pilot, cross-over randomized controlled trial took place at Diabetes Laboratory, First Department of Propaedeutic Internal Medicine, Laikon General Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece the from February 2024 to June of 2024. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers Only, Healthy Adults
- What is being tested?
- PSAI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 1 Feb 2024to 5 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Clinically healthy adults
- Speaking and writing in Greek language
Who cannot join
- Participation in another stress management trial
- diagnosis of any serious mental disorder
- short-term or long-term treatment with corticosteroids
- drug addiction
Trial locations and contacts
1 site in 1 country.
Greece1 site
Post-graduate course of Stress Science and Health Promotion, NKUA
Athens, 15669
About this study
Official title: The Impact of Lifestyle Medicine on the Sense of Coherence and the Biological Age, in a Community Sample.
This two-arm, pilot, cross-over randomized controlled trial took place at Diabetes Laboratory, First Department of Propaedeutic Internal Medicine, Laikon General Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece the from February 2024 to June of 2024. The study protocol was approved by the Ethics Committee of First Department of Propaedeutic Internal Medicine, Laiko General Hospital(Protocol no 2401/February 27,2024)and was consistent with the Helsinki Declaration for human studies.
Read the detailed description
Pythagorean Self-Awareness Intervention (PSAI) to a sample of community volunteers without pre-existing pathology, with the aim of evaluating the effectiveness of PSAI compared to a control group. Primary goals are to improve lifestyle (6 pillars), increase sense of coherence, improve telomere length and reduce perceived stress. Secondary goals are to reduce negative emotions, fatigue, neuroticism and inflammation. Also, the increase in self-efficacy, emotional intelligence, health locus of control, satisfaction with life and finally the improvement of memory and blood pressure. Measurements will take place in both groups before and after the intervention and included: Self-report questionnaires for measuring psychometric and lifestyle factors, cognitive assessment, body measurements, hair cortisol concentrations and blood sampling for telomere length.
- Conditions
- Healthy Volunteers Only, Healthy Adults
- Being tested
- PSAI, Usual Care
- Keywords
- Stress, Lifestyle medicine, Telomeres, Sense of Coherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSAIBehavioural
Holistic stress management program implementing the pillars of Lifestyle Medicine
Usual CareOther
Usual care without specific treatment
| Study group | Role | What they receive |
|---|---|---|
| PSAI group | Experimental | Behavioural counselling Receives: Behavioral: PSAI |
| Control group | Other | No intervention used Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telomeres length
Quantitative PCR (qPCR) to determine relative telomere length
Measured: Before and after the intervention(2 months)
Sense of Coherence
Sense of Coherence was assessed with the Sense of Coherence scale (SOC-13). The scale consists of 13 items rated from 0 to 7. It is considered to have high internal consistency reliability and high validity when compared to other scales measuring the same personality trait.
Measured: Before and after the intervention(2 months)
Secondary outcomes (11)
Perceived Stress Scale-14
To assess perceived stress, the Greek version of the PSS questionnaire was administered, which consists of 14 items, each graded on a 5-point Likert scale. More specifically, there are seven positive and seven negative items and the total score ranges from 0 to 56. Higher PSS scores indicate higher levels of perceived in the past month
Measured: Before and after the intervention(2 months)
Pittsburgh Sleep Quality Index
Sleep quality was assessed using the Greek version of the PSQI questionnaire. The PSQI consists of 19 self-report questions, grouped into 7 components (subjective sense of sleep quality, awakening time, latent period, duration, usual sleep productivity, use of sleep medication and daytime dysfunction). The score ranges from 0 to 3, resulting in a total score ranging from 0=high sleep quality to 21=low sleep quality. A total score of > or = 5 indicates poor sleep
Measured: Before and after the intervention(2 months)
Med Diet Score
The healthy lifestyle and self-monitoring questionnaire consists of 26 items, which are divided into a 4-point Likert scale ranging from 1=never/rarely to 4= always. A higher score indicates increased health empowerment. Specifically, the HLPCQ is designed to assess one's degree of control over daily activities such as diet, daily schedule, physical activity, socialization and pessimistic thoughts
Measured: Before and after the intervention(2 months)
Electrolytic Extracellular Bioimpedance Tomography (TomEEX)
A non invasive diagnostic tool that assesses various body functions, including: (a) stress response, (b) sensory and autonomic tones and (c) activation of limbic and cortical regions of the brain. In addition, it measures sodium (Na+) and chloride (CI-) levels in 17 areas of the body.
Measured: Before and after the intervention(2 months)
Body composition analysis
Body Impedance analyzer used to estimate body composition analysis and is based on the principles of bioelectrical impedance. Impedance was measured through the legs and lower torso through a metal plate which incorporated the electrodes, as subjects stood barefoot
Measured: Before and after the intervention(2 months)
Positive and Negative Affect Schedule
a self-report instrument to assess two basic dimensions of mood: positive and negative affect. The given tool consists of two scales of 10 pieces. Each element refers to a different emotion. The respondent reports the extent to which they felt each of the emotions in the past week according to a 5-point Likert scale (1= very slightly or not at all, 5=extremely
Measured: Before and after the intervention(2 months)
General Efficacy Scale
This metric assessed each individual's perception of their abilities to work through challenging conditions and overcome everyday obstacles. It is based on a 4-point Liker-type scale ranging from 1 (not at all true) to 4 (absolutely true). The overall result is calculated by the sum of all statements. The psychometric properties of the aforementioned tool seem to be good in the Greek population
Measured: Before and after the intervention(2 months)
Life Satisfaction
consists of 15 questions and 5 self-report statements and assesses three dimensions: conscious, mental and critical evaluation of the person's life
Measured: Before and after the intervention(2 months)
Big Five Personality
measures five personality dimensions: Openness to experience, Conscientiousness, Extraversion, Agreeableness and Neuroticism and enjoys high reliability. It consists of 44 items and the respondent is asked to indicate how much they agree or disagree with each statement, where 1=Strongly Disagree, 2= Slightly Disagree, 3= Neither Agree nor Disagree, 4= Strongly Agree
Measured: Before and after the intervention(2 months)
Wong and Low Emotional Intelligence Scale
questions about how a person manages their emotions in general. The Wong-Low scale is the scale of emotional intelligence and is consists of 16 items and the participant is asked to grade gradually from 1 to 7, where the grade "1" expresses the absolute disagreement with the sentence and "7" the absolute agreement.
Measured: Before and after the intervention(2 months)
Brief international assessment of cognition
The standardized battery (BICAMS) was used to assess cognitive functions in the participants. This memory assessment tool took about 15 minutes to complete is completed and included three categories of cognitive tests: The Normal Symbol Digital Modalities Test (SDMT), which measured information processing speed, the California Verbal Learning Test-II (CVLT-II), which assessed verbal memory and subsequent immediate recall. Finally, the third test concerned short visuospatial memory Test Revised (BVMTR), which assessed visual memory and immediate recall. Low scores indicated cognitive dysfunctions and cognitive decline. The specific tool for memory assessment has been proposed to help practitioners identify a potential cognitive dysfunction in humans
Measured: Before and after the intervention(2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start1 Feb 2024
- Primary completion1 Jun 2024
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy Volunteers OnlyStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evelina Tamiolaki, National and Kapodistrian University of Athens
- Investigators
- Nicolaos Tentolouris, Professor, Study director, First Department of Propaedeutic Internal Medicine, Medical School, NKUA, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671301
- Sponsor's protocol ID
- 2401
- Acronym
- PSAI
- Status last verified
- Nov 2024
- First submitted
- 31 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon request
Publications
Athanasopoulou S, Simos D, Charalampopoulou M, Tentolouris N, Kokkinos A, Bacopoulou F, Aggelopoulou E, Zigkiri E, Chrousos GP, Darviri C, Gonos ES. Significant improvement of stress and aging biomarkers using a novel stress management program with the cognitive restructuring method "Pythagorean Self-Awareness Intervention" in patients with type 2 diabetes mellitus and healthy adults. Mech Ageing Dev. 2021 Sep;198:111538. doi: 10.1016/j.mad.2021.111538. Epub 2021 Jul 1.
PubMed 34217756Zigkiri ES, Nicolaides NC, Bacopoulou F, Simos D, Vlachakis D, Chrousos GP, Darviri C. The Effect of the Pythagorean Self-Awareness Intervention on Psychological, Lifestyle and Cognitive Measures of a Community Sample. J Mol Biochem. 2020;9(1):32-40. Epub 2020 Dec 30.
PubMed 33520744Charalampopoulou M, Bacopoulou F, Syrigos KN, Filopoulos E, Chrousos GP, Darviri C. The effects of Pythagorean Self-Awareness Intervention on breast cancer patients undergoing adjuvant therapy: A pilot randomized controlled trial. Breast. 2020 Feb;49:210-218. doi: 10.1016/j.breast.2019.12.012. Epub 2019 Dec 20.
PubMed 31901782Simos DS, Kokkinos A, Tentolouris N, Dimosthenopoulos C, Mantzou E, Artemiadis A, Bacopoulou F, Nicolaides NC, Kosta O, Chrousos GP, Darviri C. Pythagorean self-awareness intervention: A novel cognitive stress management technique for body weight control. Eur J Clin Invest. 2019 Oct;49(10):e13164. doi: 10.1111/eci.13164. Epub 2019 Sep 16.
PubMed 31421060
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Lifestyle Medicine on the Sense of Coherence and the Biological Age, in a Community Sample.
- ClinicalTrials.gov ID
- NCT06671301
- Acronym / sponsor ID
- PSAI / 2401
- Conditions
- Healthy Volunteers Only, Healthy Adults
- Keywords
- Stress, Lifestyle medicine, Telomeres, Sense of Coherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This two-arm, pilot, cross-over randomized controlled trial took place at Diabetes Laboratory, First Department of Propaedeutic Internal Medicine, Laikon General Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece the from February 2024 to June of 2024. The study protocol was approved by the Ethics Committee of First Department of Propaedeutic Internal Medicine, Laiko General Hospital(Protocol no 2401/February 27,2024)and was consistent with the Helsinki Declaration for human studies.
Detailed description
Pythagorean Self-Awareness Intervention (PSAI) to a sample of community volunteers without pre-existing pathology, with the aim of evaluating the effectiveness of PSAI compared to a control group. Primary goals are to improve lifestyle (6 pillars), increase sense of coherence, improve telomere length and reduce perceived stress. Secondary goals are to reduce negative emotions, fatigue, neuroticism and inflammation. Also, the increase in self-efficacy, emotional intelligence, health locus of control, satisfaction with life and finally the improvement of memory and blood pressure. Measurements will take place in both groups before and after the intervention and included: Self-report questionnaires for measuring psychometric and lifestyle factors, cognitive assessment, body measurements, hair cortisol concentrations and blood sampling for telomere length.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSAI group | Experimental | Behavioral: PSAIBehavioural counselling |
| Control group | Other | Other: Usual CareNo intervention used |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinically healthy adults
- Speaking and writing in Greek language
Key exclusion criteria (4 listed)
- Participation in another stress management trial
- diagnosis of any serious mental disorder
- short-term or long-term treatment with corticosteroids
- drug addiction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSAIHolistic stress management program implementing the pillars of Lifestyle Medicine | Behavioural | PSAI group |
| Usual CareUsual care without specific treatment | Other | Control group |
Primary outcome
Telomeres length
Time frame: Before and after the intervention(2 months)
Quantitative PCR (qPCR) to determine relative telomere length
Sense of Coherence
Time frame: Before and after the intervention(2 months)
Sense of Coherence was assessed with the Sense of Coherence scale (SOC-13). The scale consists of 13 items rated from 0 to 7. It is considered to have high internal consistency reliability and high validity when compared to other scales measuring the same personality trait.
11 secondary outcomes
Perceived Stress Scale-14
Time frame: Before and after the intervention(2 months)
Pittsburgh Sleep Quality Index
Time frame: Before and after the intervention(2 months)
Med Diet Score
Time frame: Before and after the intervention(2 months)
Electrolytic Extracellular Bioimpedance Tomography (TomEEX)
Time frame: Before and after the intervention(2 months)
Body composition analysis
Time frame: Before and after the intervention(2 months)
Positive and Negative Affect Schedule
Time frame: Before and after the intervention(2 months)
General Efficacy Scale
Time frame: Before and after the intervention(2 months)
Life Satisfaction
Time frame: Before and after the intervention(2 months)
Big Five Personality
Time frame: Before and after the intervention(2 months)
Wong and Low Emotional Intelligence Scale
Time frame: Before and after the intervention(2 months)
Brief international assessment of cognition
Time frame: Before and after the intervention(2 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Background: PubMed 34217756Athanasopoulou S, Simos D, Charalampopoulou M, Tentolouris N, Kokkinos A, Bacopoulou F, Aggelopoulou E, Zigkiri E, Chrousos GP, Darviri C, Gonos ES. Significant improvement of stress and aging biomarkers using a novel stress management program with the cognitive restructuring method "Pythagorean Self-Awareness Intervention" in patients with type 2 diabetes mellitus and healthy adults. Mech Ageing Dev. 2021 Sep;198:111538. doi: 10.1016/j.mad.2021.111538. Epub 2021 Jul 1.
- Background: PubMed 33520744Zigkiri ES, Nicolaides NC, Bacopoulou F, Simos D, Vlachakis D, Chrousos GP, Darviri C. The Effect of the Pythagorean Self-Awareness Intervention on Psychological, Lifestyle and Cognitive Measures of a Community Sample. J Mol Biochem. 2020;9(1):32-40. Epub 2020 Dec 30.
- Background: PubMed 31901782Charalampopoulou M, Bacopoulou F, Syrigos KN, Filopoulos E, Chrousos GP, Darviri C. The effects of Pythagorean Self-Awareness Intervention on breast cancer patients undergoing adjuvant therapy: A pilot randomized controlled trial. Breast. 2020 Feb;49:210-218. doi: 10.1016/j.breast.2019.12.012. Epub 2019 Dec 20.
- Background: PubMed 31421060Simos DS, Kokkinos A, Tentolouris N, Dimosthenopoulos C, Mantzou E, Artemiadis A, Bacopoulou F, Nicolaides NC, Kosta O, Chrousos GP, Darviri C. Pythagorean self-awareness intervention: A novel cognitive stress management technique for body weight control. Eur J Clin Invest. 2019 Oct;49(10):e13164. doi: 10.1111/eci.13164. Epub 2019 Sep 16.
- Individual participant dataSharing planned: No. Upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolaos Tentolouris, Professor study director
First Department of Propaedeutic Internal Medicine, Medical School, NKUA, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSAI in people with Healthy Volunteers Only and Healthy Adults, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telomeres length (time frame: Before and after the intervention(2 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06671301, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.