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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Greece

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.

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 groups in NCT06671301
Study groupRoleWhat they receive
PSAI groupExperimentalBehavioural counselling
Receives: Behavioral: PSAI
Control groupOtherNo intervention used
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Telomeres length

    Quantitative PCR (qPCR) to determine relative telomere length

    Measured: Before and after the intervention(2 months)

  2. 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)
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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.

  1. First posted4 Nov 2024
  2. Study start1 Feb 2024
  3. Primary completion1 Jun 2024
  4. Study completion5 Jun 2024

Resources

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)
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 34217756
  • Zigkiri 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 33520744
  • Charalampopoulou 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 31901782
  • Simos 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

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.

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