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.
adults aged 20 years and older
overweight or obesity (BMI ≥25 kg/m²)
stable body weight over the past 6 months
physically inactive.
HbA1c >12%
insulin therapy
severe psychiatry and severe chronic illnesses
diseases of the hypothalamus and pituitary and adrenal gland
Parallel
Intervention of physical activity
BehavioralThe 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
BehavioralParticipants 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
BehavioralParticipants 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.
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.
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.
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
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 0 to 40, with higher scores indicating higher perceived stress levels.
Body Mass Index (BMI)
Calculated from measured weight and height to assess changes in body composition. Body weight will be measured using a Tanita scale. Body Mass Index (BMI) will be calculated by dividing body weight in kilograms by the square of body height in meters (kg/m²). Reference values will be applied: 18.5-24.9 kg/m² as normal weight, 25-29.9 kg/m² as overweight, and ≥30 kg/m² as obesity.
HbA1c
Measured from capillary blood using a point-of-care device to assess long-term changes in blood glucose control following lifestyle interventions. HbA1c will be measured from capillary blood samples and expressed as a percentage (%) or in mmol/mol. Reference values will be applied, with 4-5.6 % (20-38 mmol/mol) considered normal, 5.7-6.4 % (39-46 mmol/mol) indicating prediabetes, and ≥6.5 % (≥48 mmol/mol) indicating diabetes.
Waist Circumference
Waist circumference will be measured at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest using a flexible measuring tape. Reference values will be applied: \<94 cm for men and \<80 cm for women as normal, 94-102 cm for men and 80-88 cm for women as increased risk, and \>102 cm for men and \>88 cm for women as high risk of metabolic complications.
Advanced Glycation End Products (AGEs)
Advanced Glycation End Products (AGEs) will be measured non-invasively in the skin using an AGE Reader device as a marker of oxidative stress. Skin autofluorescence will be assessed on the forearm of the participant's dominant arm, placed on the armrest of the AGE Reader device (DiagnOptics, Groningen, Netherlands). After entering the participant's age, the device displays the AGEs result in arbitrary units (AU). Reference values for advanced glycation end products (AGEs) will be age-dependent. For ages 20-30 years, the reference value is 1.53 ± 0.30 AU; for 30-40 years, 1.73 ± 0.42 AU; for 40-50 years, 1.81 ± 0.36 AU; for 50-60 years, 2.09 ± 0.36 AU; for 60-70 years, 2.46 ± 0.57 AU; for 70-80 years, 2.73 ± 0.55 AU; and for participants aged ≥80 years, 2.71 ± 0.44 AU.
Click on the lead sponsor to view all of their trials.
University of Zadar
Lead sponsor
General Hospital Zadar
Collaborator
School of Public Health Andrija Štampar
Collaborator
Psychiatric Hospital Ugljan
Collaborator
Agricultural, Food and Veterinary School Stanko Ožanić
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
