Clinical trial NCT06671301: The Impact of Lifestyle Medicine on the Sense Of Coherence and Biological Age in a Community Sample
Official title: The Impact of Lifestyle Medicine on the Sense of Coherence and the Biological Age, in a Community Sample.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers Only
Healthy Adults
Keywords: Stress
Lifestyle medicine
Telomeres
Sense of Coherence
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Telomeres length
timeFrame: Before and after the intervention(2 months)
measure: Sense of Coherence
timeFrame: Before and after the intervention(2 months)
Secondary outcomes:
measure: Perceived Stress Scale-14
timeFrame: Before and after the intervention(2 months)
measure: Pittsburgh Sleep Quality Index
timeFrame: Before and after the intervention(2 months)
measure: Med Diet Score
timeFrame: Before and after the intervention(2 months)
measure: Electrolytic Extracellular Bioimpedance Tomography (TomEEX)
timeFrame: Before and after the intervention(2 months)
measure: Body composition analysis
timeFrame: Before and after the intervention(2 months)
measure: Positive and Negative Affect Schedule
timeFrame: Before and after the intervention(2 months)
measure: General Efficacy Scale
timeFrame: Before and after the intervention(2 months)
measure: Life Satisfaction
timeFrame: Before and after the intervention(2 months)
measure: Big Five Personality
timeFrame: Before and after the intervention(2 months)
measure: Wong and Low Emotional Intelligence Scale
timeFrame: Before and after the intervention(2 months)
measure: Brief international assessment of cognition
timeFrame: Before and after the intervention(2 months)
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Post-graduate course of Stress Science and Health Promotion, NKUA
Study officials:
affiliation: First Department of Propaedeutic Internal Medicine, Medical School, NKUA, Greece
name: Nicolaos Tentolouris, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.