The Impact of Lifestyle Medicine on the Sense of Coherence and the Biological Age, in a Community Sample.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Telomeres length
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Telomeres length
Time Frame: Before and after the intervention(2 months)
Quantitative PCR (qPCR) to determine relative telomere length
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
- 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))
- Positive and Negative Affect Schedule(Before and after the intervention(2 months))
- General Efficacy Scale(Before and after the intervention(2 months))
- Life Satisfaction(Before and after the intervention(2 months))
- Big Five Personality(Before and after the intervention(2 months))
- Wong and Low Emotional Intelligence Scale(Before and after the intervention(2 months))
- Brief international assessment of cognition(Before and after the intervention(2 months))
Investigators
Evelina Tamiolaki
Principal investigator
National and Kapodistrian University of Athens