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

NCT06671301 | Completed

• 1 other identifier: 2401
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Volunteers Only; Healthy Adults

Keywords

Stress; Lifestyle medicine; Telomeres; Sense of Coherence

Outcome Measures

Primary Outcomes (2)

• Telomeres length

  Quantitative PCR (qPCR) to determine relative telomere length

  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.

  Before and after the intervention(2 months)

Secondary Outcomes (11)

• Perceived Stress Scale-14

  Before and after the intervention(2 months)

• Pittsburgh Sleep Quality Index

  Before and after the intervention(2 months)

• Med Diet Score

  Before and after the intervention(2 months)

• Electrolytic Extracellular Bioimpedance Tomography (TomEEX)

  Before and after the intervention(2 months)

• Body composition analysis

  Before and after the intervention(2 months)

Study Arms (2)

PSAI group

EXPERIMENTAL

Behavioural counselling

Behavioral: PSAI

Control group

OTHER

No intervention used

Other: Usual Care

Interventions

PSAI BEHAVIORAL

Holistic stress management program implementing the pillars of Lifestyle Medicine

PSAI group

Usual Care OTHER

Usual care without specific treatment

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically healthy adults
• Speaking and writing in Greek language

You may not qualify if:

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

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

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

Athens, 15669, Greece

Location

Related Publications (4)

• 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.

  PMID: 34217756 BACKGROUND

• 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.

  PMID: 33520744 BACKGROUND

• 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.

  PMID: 31901782 BACKGROUND

• 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.

  PMID: 31421060 BACKGROUND

Study Officials

• Nicolaos Tentolouris, Professor

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 4, 2024
• Study Start: February 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 5, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)