NUTRI-M-CareMediterranean Diet and Physical Activity for Middle-aged Adults with Metabolic Syndrome
energy reduced Mediterranean diet (25% caloric restriction) plus physical activity program
+ Usual Care
Behavior+14
+ Body Weight
+ Body Weight Changes
Treatment Study
Summary
Study start date: May 1, 2025
Actual date on which the first participant was enrolled.This study focuses on helping middle-aged adults who have Metabolic Syndrome (MetS), which is a condition associated with high blood sugar, high blood pressure, abdominal obesity, and abnormal cholesterol levels. These factors can lead to serious health problems like heart disease, diabetes, and even cancer. The study aims to see if changing eating habits to a Mediterranean diet with fewer calories and increasing physical activity can help manage or reverse MetS. This approach is important because it could improve the overall health of those affected, reduce the need for chronic medication, and lessen the financial burden on healthcare systems. In this study, participants aged 30 to 50 with MetS will be divided into two groups. One group will follow a structured program for six months, while the other group will receive standard health advice from nurses. Researchers will collect various types of data, including physical measurements, dietary habits, and medical test results, to assess the effectiveness of the intervention. After one year, the study will evaluate how well participants have continued their new habits. The goal is to see if these lifestyle changes can be maintained and to identify any factors that help or hinder this process.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.106 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 30 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * BMI 27-40 Kg/m2 * Metabolic syndrome according to International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity * Stable weight in the last 3 months (weight changes \< 4Kg) * Be able to give informed consent Exclusion Criteria: * Have a diagnosed illness that interferes with the recommendations proposed in the intervention. * Women with established menopause. * Pregnant or breastfeeding women. * Serious psychiatric illness/disorder. * Social, cultural or psychological factors that may affect adherence to the intervention protocol. * Inability to communicate with study staff. * Inability to follow recommended diet or inability to engage in physical activity. * Low likelihood of modifying dietary habits according to the different stages of change according to the Prochaska and DiClemente model. * Difficulty attending scheduled appointments within the intervention due to work schedule conflicts, travel plans, scheduled surgeries, among other reasons. * Therapeutic non-compliance. * Participating in a professionally-led nutritional intervention. * Being under medical treatment that affects weight, intake or energy expenditure in the 3 months preceding the start of the study. Smokers who have changed their smoking habit in the 6 months preceding the start of the study (including starting or stopping smoking). \- Participation in another trial that may interfere with this proposed study.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives