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Completed

NCT Number: NCT06671301

The Impact of Lifestyle Medicine on the Sense Of Coherence and 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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Athens, 15669, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PSAI

Behavioral

Holistic stress management program implementing the pillars of Lifestyle Medicine

Usual Care

Other

Usual care without specific treatment

Primary outcomes

  1. Telomeres length

    Time frame: Before and after the intervention(2 months)

    Quantitative PCR (qPCR) to determine relative telomere length

  2. 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.

Secondary outcomes

  1. Perceived Stress Scale-14

    Time frame: Before and after the intervention(2 months)

    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

  2. Pittsburgh Sleep Quality Index

    Time frame: Before and after the intervention(2 months)

    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

  3. Med Diet Score

    Time frame: Before and after the intervention(2 months)

    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

  4. Electrolytic Extracellular Bioimpedance Tomography (TomEEX)

    Time frame: Before and after the intervention(2 months)

    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.

  5. Body composition analysis

    Time frame: Before and after the intervention(2 months)

    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

  6. Positive and Negative Affect Schedule

    Time frame: Before and after the intervention(2 months)

    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

  7. General Efficacy Scale

    Time frame: Before and after the intervention(2 months)

    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

  8. Life Satisfaction

    Time frame: Before and after the intervention(2 months)

    consists of 15 questions and 5 self-report statements and assesses three dimensions: conscious, mental and critical evaluation of the person's life

  9. Big Five Personality

    Time frame: Before and after the intervention(2 months)

    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

  10. Wong and Low Emotional Intelligence Scale

    Time frame: Before and after the intervention(2 months)

    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.

  11. Brief international assessment of cognition

    Time frame: Before and after the intervention(2 months)

    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

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Official study title

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

Acronym: PSAI

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 4, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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