Impact of Lifestyle on Health Maintenance: A Randomized Controlled Trial

Официальное название

The Role of Lifestyle in Maintaining Health: Biological, Psychological and Social Responses of the Organism to Lifestyle

Обзор

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.

Подробное описание

Contemporary lifestyle patterns are characterized by a fast pace of life, exposure to stressful stimuli, and unhealthy habits. Physically inactive adults who are exposed to stress, smoke, and have poor dietary habits are at increased risk of developing metabolic syndrome, oxidative stress, overweight, hormonal imbalance, insulin resistance, impaired mental health, and lower health-related quality of life.

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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 address
• Поведенческое 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.

Первичные конечные точки

• Mediterranean diet adherence [Срок оценки: Baseline, 3 months after intervention, 6 months after intervention, and 12 months after intervention]
• Physical Activity [Срок оценки: Baseline, 3 months after intervention, 6 months after intervention, and 12 months after intervention]
• Sleep Hygiene [Срок оценки: Baseline, 3 months after intervention, 6 months after intervention, and 12 months after intervention]
• Perceived Stress [Срок оценки: Baseline, 3 months after intervention, 6 months after intervention, and 12 months after intervention]
• Healthy Days (Physical and Mental Health) [Срок оценки: Baseline, 3 months after intervention, 6 months after intervention, and 12 months after intervention]

Вторичные конечные точки (10)

• Body Mass Index (BMI) [Срок оценки: Baseline, 3 months after intervention, 6 months after intervention, and 12 months after intervention]
• HbA1c [Срок оценки: Baseline, 3 months after intervention, 6 months after intervention, and 12 months after intervention]
• Waist Circumference [Срок оценки: Baseline, 3 months after intervention, 6 months after intervention, and 12 months after intervention]
• Advanced Glycation End Products (AGEs) [Срок оценки: Baseline, 3 months after intervention, 6 months after intervention, and 12 months after intervention]
• Lipid Profile (Total Cholesterol, LDL, HDL, Triglycerides) [Срок оценки: Baseline, 3 months after intervention, 6 months after intervention, and 12 months after intervention]
• HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) [Срок оценки: Baseline, 3 months after intervention, 6 months after intervention, and 12 months after intervention]
• Salivary Cortisol [Срок оценки: Baseline, 3 months after intervention]
• Psychological Resilience [Срок оценки: Baseline, 3 months after intervention, 6 months after intervention, and 12 months after intervention]
• Mental Health - The Generalized Anxiety Disorder Scale (GAD-7) [Срок оценки: Baseline, 3 months after intervention, 6 months after intervention, and 12 months after intervention]
• Mental Health -The Patient Health Questionnaire (PHQ-9) [Срок оценки: Baseline, 3 months after intervention, 6 months after intervention, and 12 months after intervention]

Критерии участия

Критерии включения

• adults aged 20 years and older
• overweight or obesity (BMI ≥25 kg/m²),
• stable body weight over the past 6 months
• physically inactive.

Критерии исключения

• HbA1c >12%
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Хорватия · 1 центр

• University of Zadar — Zadar

Публикации

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Идентификаторы

NCT: NCT07314957 · IP UNIZD 2025-27040 · EU Next Generation NPOO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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