Impact of Lifestyle on Health Maintenance: A Randomized Controlled Trial

NCT07314957 | Not Yet Recruiting

• 2 other identifiers: IP UNIZD 2025-27040EU Next Generation NPOO
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

Habits; Lifestlye; Nutrition; Phisical activity; Stress; Metabolic syndrome; Mental health; Sleep

Outcome Measures

Primary Outcomes (5)

• 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.

  Baseline, 3 months after intervention, 6 months after intervention, and 12 months after intervention

• 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.

  Baseline, 3 months after intervention, 6 months after intervention, and 12 months after intervention

• 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

  Baseline, 3 months after intervention, 6 months after intervention, and 12 months after intervention

• 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.

  Baseline, 3 months after intervention, 6 months after intervention, and 12 months after intervention

• Healthy Days (Physical and Mental Health)

  Assessed using the CDC Healthy Days questionnaire to evaluate the number of days in the past 30 days when participants perceived their physical or mental health as not good. The Health Related Quality of Life 14 item measure (CDC HRQOL 14) is a generic self report questionnaire developed by the U.S. Centers for Disease Control and Prevention to assess overall health related quality of life. It comprises 14 items that capture perceived physical and mental health status over the past 30 days, including self rated general health, the number of days with poor physical health, poor mental health, days when health limited usual activities, and additional questions on activity limitations and symptoms such as pain, depression, anxiety, rest, and energy. The measure provides a summary of health related quality of life and has been widely used in public health surveillance, research, and population health studies. Higher scores generally reflect poorer health related quality of life.

  Baseline, 3 months after intervention, 6 months after intervention, and 12 months after intervention

Secondary Outcomes (10)

• Body Mass Index (BMI)

  Baseline, 3 months after intervention, 6 months after intervention, and 12 months after intervention

• HbA1c

  Baseline, 3 months after intervention, 6 months after intervention, and 12 months after intervention

• Waist Circumference

  Baseline, 3 months after intervention, 6 months after intervention, and 12 months after intervention

• Advanced Glycation End Products (AGEs)

  Baseline, 3 months after intervention, 6 months after intervention, and 12 months after intervention

• Lipid Profile (Total Cholesterol, LDL, HDL, Triglycerides)

  Baseline, 3 months after intervention, 6 months after intervention, and 12 months after intervention

Study Arms (2)

Control Group

NO INTERVENTION

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.

Lifestyle intervention group

EXPERIMENTAL

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..

Behavioral: Intervention of physical activity; Behavioral: Mediterranean Diet Education; Behavioral: Behavioral: Stress-Resilience Training

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.

Lifestyle intervention group

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.

Lifestyle intervention group

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.

Lifestyle intervention group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zadar: lead
• General Hospital Zadar: collaborator
• School of Public Health Andrija Štampar: collaborator
• Psychiatric Hospital Ugljan: collaborator
• Agricultural, Food and Veterinary School Stanko Ožanić: collaborator

Study Sites (1)

University of Zadar

Zadar, 23000, Croatia

Location

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MeSH Terms

Conditions

Metabolic Syndrome; Smoking; Sleep Wake Disorders; Obesity; Overweight; Anxiety Disorders; Consciousness Disorders; Habits; Psychological Well-Being

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Overnutrition; Nutrition Disorders; Body Weight; Neurobehavioral Manifestations; Neurocognitive Disorders; Personal Satisfaction

Central Study Contacts

Marija Ljubičić, Phd, Assistant professor

CONTACT

+385981771804; mljubicic@unizd.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: No other parties besides participants are masked. Researchers, study staff, and outcome assessors are aware of group assignments due to the nature of the interventions. This open-label design allows proper supervision of physical activity, dietary education, and stress-resilience training.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PhD, Department of Health Studies, University of Zadar, Croatia

Model Details: This randomized, interventional study evaluates the effects of lifestyle interventions on metabolic, oxidative, and psychological health in adults with overweight or obesity. Participants are randomly assigned to one of two groups: combined lifestyle group (physical activity, nutrition education, stress-resilience training), and control group receiving no interventions. The study uses open-label allocation with parallel groups to assess causality between lifestyle intervention and health outcomes. Randomization is performed using a computerized random generator. Participants' adherence is monitored via smart bracelets tracking heart rate, steps, and sleep. Outcomes, including metabolic parameters, oxidative stress, hormonal responses, anthropometric measures, stress, quality of life, are assessed at baseline and at 3, 6,12, months folow-up.

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 2, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)