Impact of Lifestyle on Health Maintenance: A Randomized Controlled Trial
NCT ID: NCT07314957
Last Updated: 2026-02-12
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2026-09-01
2027-12-31
Brief Summary
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Detailed Description
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Studies confirm that lifestyle is one of the most influential modifiable factors in disease development. This study aims to evaluate whether a structured lifestyle intervention, including supervised physical exercise, adherence to a healthy diet, and stress-resilience training, can improve metabolic health, reduce oxidative stress, and enhance mental health and quality of life in adults with overweight, compared to a control group receiving standard lifestyle advice. Participants will be randomly assigned to one of two groups: supervised lifestyle group with exercise , Mediterranean diet education , stress-resilience and support; and control group receiving standard lifestyle recommendations. Participants in the experimental groups will engage in regular physical activity, follow a Mediterranean diet, participate in psychological resilience-building workshops and support groups, and attend weekly individual and group sessions, followed by a 12-month follow-up period.
The study will assess anthropometric measures (body weight, waist and hip circumference), metabolic parameters (blood glucose, HbA1c, cholesterol, HOMA-IR), oxidative stress markers (AGEs), hormonal responses (cortisol, thyroid hormones), mental health, perceived stress, and quality of life. Participants will wear smart bracelets to monitor daily activity, steps, heart rate, and sleep. Measurements will be taken at baseline, immediately after the 12-week intervention (3 month), and during follow-up at 6, and 12 months.
The investigators hypothesize that the structured lifestyle intervention combining physical activity, Mediterranean diet education, and stress-resilience training will lead to significant improvements in metabolic, oxidative, and psychological health outcomes compared to standard lifestyle advice.
The scientific findings gained from this study may significantly contribute to understanding the effectiveness of lifestyle interventions in preventing chronic diseases associated with unhealthy lifestyles. The findings from this study are expected to provide insights into effective lifestyle interventions for at-risk populations, ultimately benefiting both individuals and communities. These interventions can improve the effectiveness of programs aimed at preventing the development of metabolic and chronic diseases, thereby enhancing overall health and quality of life. In addition, the results are anticipated to contribute to evidence-based public health policies and inform strategies for the prevention and management of chronic non-communicable diseases.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
No interventions assigned to this group
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..
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.
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: 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.
Interventions
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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.
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: 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.
Eligibility Criteria
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Inclusion Criteria
* overweight or obesity (BMI ≥25 kg/m²),
* stable body weight over the past 6 months
* physically inactive.
Exclusion Criteria
* insulin therapy
* severe psychiatry and severe chronic illnesses of parents
* diseases of the hypothalamus and pituitary and adrenal gland
* mobility restriction
* tetraplegia
* use of obesity pharmacotherapy
* malignant disease and chemotherapy
* pregnancy
20 Years
ALL
Yes
Sponsors
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General Hospital Zadar
OTHER
School of Public Health Andrija Štampar
UNKNOWN
Psychiatric Hospital Ugljan
INDIV
Agricultural, Food and Veterinary School Stanko Ožanić
UNKNOWN
University of Zadar
OTHER
Responsible Party
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Marija Ljubičić
Assistant Professor, PhD, Department of Health Studies, University of Zadar, Croatia
Locations
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University of Zadar
Zadar, , Croatia
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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EU Next Generation NPOO
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IP UNIZD 2025-27040
Identifier Type: -
Identifier Source: org_study_id
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