The Impact of Lifestyle Medicine on the Sense Of Coherence and Biological Age in a Community Sample

NCT ID: NCT06671301

Last Updated: 2024-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-06-05

Brief Summary

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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

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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

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Healthy Volunteers Only Healthy Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PSAI group

Behavioural counselling

Group Type EXPERIMENTAL

PSAI

Intervention Type BEHAVIORAL

Holistic stress management program implementing the pillars of Lifestyle Medicine

Control group

No intervention used

Group Type OTHER

Usual Care

Intervention Type OTHER

Usual care without specific treatment

Interventions

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PSAI

Holistic stress management program implementing the pillars of Lifestyle Medicine

Intervention Type BEHAVIORAL

Usual Care

Usual care without specific treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinically healthy adults
* Speaking and writing in Greek language

Exclusion Criteria

* Participation in another stress management trial
* diagnosis of any serious mental disorder
* short-term or long-term treatment with corticosteroids
* drug addiction
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Evelina Tamiolaki

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicolaos Tentolouris, Professor

Role: STUDY_DIRECTOR

First Department of Propaedeutic Internal Medicine, Medical School, NKUA, Greece

Locations

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Post-graduate course of Stress Science and Health Promotion, NKUA

Athens, , Greece

Site Status

Countries

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Greece

References

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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.

Reference Type BACKGROUND
PMID: 34217756 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33520744 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31901782 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31421060 (View on PubMed)

Other Identifiers

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2401

Identifier Type: -

Identifier Source: org_study_id

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