Beneficial Effects of Dietary and Lifestyle Change in Overweight and Obese Subjects (Healthy-MET)

University of Bari

Status: Not yet enrolling

Conditions: Overweight and Obesity; Cardiovascular Diseases; Non-Alcoholic Fatty Liver Disease; Metabolic Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT05447351

HEALTHYMET01-2022

Details and patient eligibility

About

Obesity and overweight are noncommunicable diseases with increasing incidence in children, adolescents and adults. In 2016, more than 1.9 billion adults aged 18 and over were overweight and over 650 million were obese (WHO). In the EU-27 (Eurostat data), 45.7% of women and 60.2% of men were overweight, while 16.3% and 16.8%, respectively, were obese. The growing incidence of overweight and obesity generate worldwide increasing incidence of related conditions as cardiovascular diseases, diabetes, metabolic disorders, and cancer, with relevant socio-economical (increase in health costs, increase in disabilities) and environmental consequences (unsustainability of food models, increase in ecological footprint, worsening of climate changes). A transformation of food systems and individual behaviours are necessary to improve the quality of life and the sustainability of lifestyle, which should be oriented at preventing o treating overweight and obesity.

Full description

The study is aimed to measure the beneficial effects of specific dietary models (i.e., Mediterranean Diet) and healthy lifestyle (i.e., controlled physical activity) in reducing body/organ fat accumulation and in the improvement of metabolic health. A comprehensive and combined analysis of these effects (mainly following personalized strategies and close follow-up) on pathogenic mechanisms affecting cardiovascular and metabolic risk, pro-inflammatory status and intestinal permeability in the medium-long term is still lacking.

During the study, overweight/obese subjects (i.e. Body Mass Index equal or higher to 25Kg/m2) will be assessed at basal and monitored during a 24 months follow-up

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• overweight or obese patients
• patients who able to sign informed consent

Exclusion criteria

• failure to sign informed consent;
• inclusion in other research protocols
• Normal weight patients

Trial design

200 participants in 2 patient groups

Treated

Description:

Counselling, personalized dietary strategy aimed at increasing the adherence to Mediterranean diet, personalized physical activity program with a personal trainer, use of digital tools (i.e., games, apps) aimed at improving the adherence to dietary/lifestyle indications.

Control

Description:

generic dietary indications oriented to weight reduction; generic invitations to increase physical activity, routine monitoring