Impact of Lifestyle on Health Maintenance: A Randomized Controlled Trial

Summary

This study aims to evaluate the impact of public health interventions on changes in healthy lifestyle habits over time and their subsequent effects on health outcomes. The investigators hypothesize that exposing at-risk populations to structured physical activity programs, education on healthy nutrition, promotion of the Mediterranean diet, and workshops focused on strengthening psychological resilience will lead to improvements in anthropometric, oxidative, metabolic, and psychological parameters. Anthropometric and laboratory measures will be collected at multiple time points throughout the study. The longitudinal follow-up will span 12 months. It is anticipated that sustained adherence to healthy lifestyle behaviors will result in positive lifestyle changes and enhanced health-related quality of life.

Conditions

• Metabolic Syndrome
• Inactivity/Low Levels of Exercise
• Unhealthy Diet
• Unhealthy Alcohol Use
• Smoking Behaviors
• Stress
• Sleep Disorder
• Obesity & Overweight
• Anxiety
• Depressed Mood
• Emotional Eating Behaviour

Interventions

BEHAVIORAL

Intervention of physical activity

The intervention combines supervised physical activity (2 times a week for 12 weeks) with the use of a smart bracelet to continuously monitor heart rate, steps and hours of sleep. The intervention aims to reduce sedentary behavior and improve metabolic, oxidative and psychological health in adults with overweight or obesity.

BEHAVIORAL

Mediterranean Diet Education

Participants will take part in a 12 week nutritional intervention, followed by a 12 month follow-up period. The program includes 14 weekly group education sessions and one 30-minute individual consultation. Group sessions cover healthy eating principles, Mediterranean diet, intuitive eating, meal planning, hunger and satiety awareness, emotional triggers, mindful eating, real-life nutrition situations, motivation, and strategies for maintaining healthy habits. The individual consultation addresses personal challenges and tailors dietary guidance to the participant's lifestyle and health status. Dietary intake is monitored using structured 24-hour recalls at multiple time points throughout the intervention and follow-up periods.Participants will wear smart bracelets to monitor physical activity, heart rate, and sleep to track their daily routine and progress.

BEHAVIORAL

Behavioral: Stress-Resilience Training

Participants will take part in a 12-week program focused on strengthening psychological resilience and stress management. The program includes workshops and group support sessions to encourage experience sharing and motivation, with additional online and telephone support. Participants will wear smart bracelets to monitor physical activity, heart rate, and sleep to track their daily routine and progress.

Sponsors & Collaborators

• General Hospital Zadar

  collaborator OTHER

• School of Public Health Andrija Štampar

  collaborator UNKNOWN

• Psychiatric Hospital Ugljan

  collaborator INDIV

• Agricultural, Food and Veterinary School Stanko Ožanić

  collaborator UNKNOWN

• University of Zadar

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• Croatia

Study Locations