Impact of Lifestyle on Health Maintenance: A Randomized Controlled Trial

Sponsor
University of Zadar
Study ID
NCT07314957
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Intervention of physical activity — BEHAVIORAL
    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.
  • Mediterranean Diet Education — BEHAVIORAL
    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: Stress-Resilience Training — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Jan 2, 2026
Start date
Sep 1, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control Group
    Adults aged 20 years and older with overweight or obesity (BMI ≥25 kg/m²), stable body weight over the past 6 months and be physically inactive.
  • Experimental: Lifestyle intervention group
    Adults aged 20 years and older with overweight or obesity (BMI ≥25 kg/m²), stable body weight over the past 6 months and be physically inactive..

Primary Outcome Measure

Mediterranean diet adherence [ Time Frame: Baseline, 3 months after intervention, 6 months after intervention, and 12 months after intervention ]

Central Contacts

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