Not Yet RecruitingNot Applicable

Impact of Lifestyle on Health Maintenance: A Randomized Controlled Trial

Croatia120 participantsStarted 2026-09-01

Plain-language 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.

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mediterranean diet adherence

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

Physical Activity

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

Sleep Hygiene

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

Perceived Stress

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

Healthy Days (Physical and Mental Health)

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

Trial details

NCT IDNCT07314957

SponsorUniversity of Zadar

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Marija Ljubičić, Phd, Assistant professor

+385981771804 mljubicic@unizd.hr

View on ClinicalTrials.gov More Metabolic Syndrome trials

Plain-language summary

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Mediterranean diet adherence

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

Physical Activity

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

Sleep Hygiene

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

Perceived Stress

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

Healthy Days (Physical and Mental Health)

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