Impact of Lifestyle on Health Maintenance: A Randomized Controlled Trial

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Behavioral 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.
• Behavioral 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
• Behavioral 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.

Primary outcome measures

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

Secondary outcome measures (10)

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Croatia · 1 center

• University of Zadar — Zadar

Publications

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. PMID 11556941
• Stalder T, Kirschbaum C, Kudielka BM, Adam EK, Pruessner JC, Wust S, Dockray S, Smyth N, Evans P, Hellhammer DH, Miller R, Wetherell MA, Lupien SJ, Clow A. Assessment of the cortisol awakening response: Expert consensus guidelines. Psychoneuroendocrinology. 2016 Jan;63:414-32. doi: 10.1016/j.psyneuen.2015.10.010. Epub 2015 Oct 20. PMID 26563991
• Amanat S, Sinaei E, Panji M, MohammadporHodki R, Bagheri-Hosseinabadi Z, Asadimehr H, Fararouei M, Dianatinasab A. A Randomized Controlled Trial on the Effects of 12 Weeks of Aerobic, Resistance, and Combined Exercises Training on the Serum Levels of Nesfatin-1, Irisin-1 and HOMA-IR. Front Physiol. 2020 Oct 16;11:562895. doi: 10.3389/fphys.2020.562895. eCollection 2020. PMID 33178035
• Jaacks LM, Sher S, Staercke C, Porkert M, Alexander WR, Jones DP, Vaccarino V, Ziegler TR, Quyyumi AA. Pilot randomized controlled trial of a Mediterranean diet or diet supplemented with fish oil, walnuts, and grape juice in overweight or obese US adults. BMC Nutr. 2018;4:26. doi: 10.1186/s40795-018-0234-y. Epub 2018 May 31. PMID 30271610
• Leemann L, Martelin T, Koskinen S, Härkänen T, Isola AM. Development and Psychometric Evaluation of the Experiences of Social Inclusion Scale. J Hum Dev Capab 2022;23:400-24. https://doi.org/10.1080/19452829.2021.1985440.
• Canty-Mitchell J, Zimet GD. Psychometric properties of the Multidimensional Scale of Perceived Social Support in urban adolescents. Am J Community Psychol. 2000 Jun;28(3):391-400. doi: 10.1023/A:1005109522457. PMID 10945123
• Mastin DF, Bryson J, Corwyn R. Assessment of sleep hygiene using the Sleep Hygiene Index. J Behav Med. 2006 Jun;29(3):223-7. doi: 10.1007/s10865-006-9047-6. Epub 2006 Mar 24. PMID 16557353
• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. PMID 16717171

Identifiers

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

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗