Lifestyle and Its Association With Maintaining Health

NCT07309484 | Enrolling By Invitation

• 2 other identifiers: IP UNIZD 2025-27040_obsEU Next Generation NPOO
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

This study is part of the LIFEHEALTH project and will be carried out in five Mediterranean European Union countries: Croatia, Greece, Italy, Slovenia, and Spain. The aim of this study is to assess adults' lifestyle habits and how they relate to their physical and mental health. Respondents in each country will be invited to complete an online questionnaire. The survey will ask about consumption of the Mediterranean diet, physical activity, sleep habits, stress perception, mental health, social relationships, and overall health. Each country will include about 500 participants to ensure a representative sample of adults living in Mediterranean regions.The questionnaire will be translated into local languages and participation is voluntary. Multiple linear or logistic regresion wil be used to assess relation between variables. These analyses will help identify which factors are most strongly linked to health outcomes. The results of this study will help researchers describe current lifestyle patterns in the Mediterranean population. They will also examine how different lifestyle habits are linked to physical and mental health. The findings may support public health initiatives and help plan future research to improve health and well-being.

Conditions

Lifestyle (Sedentary Behavior and Physical Activity); Mental Health; Nutrition; Sleep; Stress; Unhealthy Diet, Exercise, Smoking, and Alcohol Use; Body Mass Index

Keywords

Lifestyle; stress; nutrition; sleep; depression; anxiety; smoking; physical activity; Mediterranean Diet; social relationship; attitude

Outcome Measures

Primary Outcomes (7)

• Mediterranean diet adherence

  Assessed using validated dietary questionnaires to evaluate participants' adherence to Mediterranean diet principles and monitor changes over time. The Mediterranean Dietary Serving Score (MDSS) evaluates 14 food groups, including cereals, fruits, vegetables, olive oil, nuts, dairy, meat, fish, eggs, legumes, potatoes, wine/beer, and sweets. Consumption is rated on a 7-point Likert scale. Scores above 14 indicate regular adherence to a Mediterranean diet.

  through study completion, an average of 1 year

• Physical Activity

  Assessed using the Godin Leisure-Time Exercise Questionnaire to evaluate participants' frequency and intensity of physical activity during free time, and to monitor changes in exercise behavior over time. Godin Leisure-Time Exercise Questionnaire (GLTEQ), calculates a total score by multiplying the weekly frequency of strenuous, moderate, and light activities by 9, 5, and 3, respectively. Higher scores indicate greater levels of physical activity and allow monitoring of changes in exercise behavior over time.

  through study completion, an average of 1 year

• Sleep Hygiene

  Assessed using validated sleep hygiene questionnaires to evaluate participants' sleep habits, routines, and behaviors that promote restorative sleep. The Sleep Hygiene Index (SHI) consists of 13 items for self-assessment of sleep-related behaviors. Participants rate how often they engage in specific behaviors on a 5-point scale: 0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = always. Scores are summed to provide a global sleep hygiene score, with higher scores indicating poorer (maladaptive) sleep hygiene and a greater presence of behaviors that disrupt sleep quality

  through study completion, an average of 1 year

• Perceived Stress

  Self-reported questionnaire to assess perceived stress levels. The Perceived Stress Scale-10 (PSS-10) assesses the perception of stressful situations over the past month through 10 items rated on a 0-4 scale. Total scores range from

  through study completion, an average of 1 year

• Attitudes toward a Healthy Lifestyle

  The Attitudes toward a Healthy Lifestyle Questionnaire is based on six core domains of lifestyle medicine: balanced nutrition, regular physical activity, effective stress management, sleep quality, quality of interpersonal relationships, and avoidance of risky behaviors such as smoking and alcohol consumption. The instrument consists of 15 items. Responses are recorded using a 5-point Likert scale, where 1 indicates complete disagreement and 5 indicates complete agreement with the statement. Reverse scoring is applied to negatively worded items (items 1, 4, 7, 8, 10, and 12). The total scale score is calculated by summing the responses to all items, resulting in a possible score range from 15 to 75. Higher total scores reflect more positive attitudes toward a healthy lifestyle.

  through study completion, an average of 1 year

• Healthy Days (Physical and Mental Health)

  Assessed using the CDC Healthy Days questionnaire to evaluate the number of days in the past 30 days when participants perceived their physical or mental health as not good. The Health Related Quality of Life 14 item measure (CDC HRQOL 14) is a generic self report questionnaire developed by the U.S. Centers for Disease Control and Prevention to assess overall health related quality of life. It comprises 14 items that capture perceived physical and mental health status over the past 30 days, including self rated general health, the number of days with poor physical health, poor mental health, days when health limited usual activities, and additional questions on activity limitations and symptoms such as pain, depression, anxiety, rest, and energy. The measure provides a summary of health related quality of life and has been widely used in public health surveillance, research, and population health studies. Higher scores generally reflect poorer health related quality of life.

  through study completion, an average of 1 year

• Personal Wellbeing

  Personal Wellbeing Index (PWI) is self-report measuring subjective well-being across seven domains: standard of living, health, achieving in life, personal relationships, personal safety, community-connectedness, and future security. Each domain is rated on an 11-point Likert scale (0-10), with higher scores indicating greater subjective well-being. The total PWI score is calculated as the mean of the domain scores.

  through study completion, an average of 1 year

Secondary Outcomes (4)

• Association between lifestyle habits and physical health

  through study completion, an average of 1 year

• Association between lifestyle habits and mental health

  through study completion, an average of 1 year

• Sociodemographic and health-related characteristics

  through study completion, an average of 1 year

• Associations between lifestyle domains and body mass index.

  through study completion, an average of 1 year

Study Arms (1)

Group includes approximately 2500 respondents from European Union

This group includes approximately 500 respondents from each of five Mediterranean European Union countries: Croatia, Greece, Italy, Slovenia, and Spain. Participants are adults who will complete an online questionnaire on lifestyle habits, diet, physical activity, sleep, stress perception, mental health, social relationships, and overall health. The aim is to describe current lifestyle patterns and examine how these habits relate to physical and mental health in Mediterranean populations. Participation is voluntary, and respondents can withdraw at any time.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In this cross-sectional study, participants from selected European Union countries will complete an online questionnaire covering key aspects of health, dietary habits, physical activity, mental health, and socioeconomic factors. Participants will be recruited from healthcare and educational institutions, fitness centers, online platforms, workplaces, associations, as well as through advertising materials and media outreach.

You may qualify if:

• Adults aged 18 years or older
• Residents of participating European countries
• Access to the internet
• Ability to provide informed consent
• Completion of the online questionnaire

You may not qualify if:

• Individuals under 18 years of age
• Non-residents of the participating European countries
• Inability to understand the language of the questionnaire
• Cognitive and/or technical difficulties preventing completion of the online questionnaire

Sponsors & Collaborators

• General Hospital Zadar: collaborator
• Agricultural, Food and Veterinary School Stanko Ožanić, Zadar, Croatia: collaborator
• University of Primorska: collaborator
• University of Cadiz: collaborator
• University of Camerino: collaborator
• International Hellenic University: collaborator
• University of Split, School of Medicine: collaborator
• Andrija Stampar Teaching Institute of Public Health: collaborator
• University of Zadar: lead

Study Sites (1)

University of Zadar

Zadar, 23000, Croatia

Location

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity; Psychological Well-Being; Smoking; Alcohol Drinking; Depression; Anxiety Disorders; Behavior

Condition Hierarchy (Ancestors)

Personal Satisfaction; Drinking Behavior; Behavioral Symptoms; Mental Disorders

Study Officials

• Marija Ljubičić

  University of Zadar, Croatia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PhD, Department of Health Studies, University of Zadar, Croatia

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 30, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 12, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)