Type 2 Diabetes Mellitus (T2DM)HypertensionObesity and Type 2 DiabetesCardiovascular Diseases
Investigational drug(s) / intervention(s)
Comparison of eating windows intervention
Comparison of eating windows intervention: Participants will be randomized into two groups to follow either a daytime or nighttime eating window, with normocaloric meal plans based on the Mediterranean diet adapted to Brazilian culture. The first intervention phase will last 6 months, followed by a 3-month washout period during which participants return to their usual eating patterns. After the washout, participants will resume the same eating window for an additional 6 months. A final follow-up assessment will be conducted 3 months post-intervention to evaluate the stability of behavioral changes.
Study summary
This project aims to offer a quantitative and qualitative nutritional approach, along with educational nutritional guidelines for participants with Non-Communicable Chronic Diseases. The main goals are: 1- Regularization of eating habits and windows; 2- Modulation of biochemical, anthropometric, and cardiovascular parameters; 3- Increase in knowledge about healthy eating. In this way, participants will undergo a complete nutritional assessment, comprising anthropometry, biochemistry, clinical, and dietary evaluations.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* Age: Adults \>18 years \< 80 years; Diagnosis of obesity, diabetes, and hypertension (Obesity is diagnosed when Body Mass Index (BMI) is equal to or greater than 30 kg/m², diabetes is diagnosed when fasting plasma glucose is ≥ 126 mg/dL (7.0 mmol/L), 2-hour plasma glucose during an oral glucose tolerance test is ≥ 200 mg/dL (11.1 mmol/L), HbA1c is ≥ 6.5%, or random plasma glucose is ≥ 200 mg/dL (11.1 mmol/L) with symptoms, and hypertension is diagnosed when blood pressure is consistently ≥ 140/90 mmHg on repeated measurements.); Gender: Male and female; Availability to attend quarterly meetings over a period of 18 months; Sedentary.
Exclusion Criteria:
* Difficulties in responding to the requested instruments; Impediments to regular attendance in data collection; No diagnosis of Obesity, Diabetes, and Hypertension; Use of insulin therapy, Sodium-Glucose Cotransporter-2 (SGLT-2) inhibitors, and Glucagon-Like Peptide-1 (GLP-1) analogs; Chronic Kidney Disease patients; Normal weight or undernourished individuals; Physical exercise practitioners (\>150 minutes of exercise/week).
Primary outcome measure(s)
Weight (Kg) — 5 assessment points - Month 0 (baseline), Month 6 (end of first intervention phase), Month 9 (end of washout), Month 15 (end of second intervention phase), FOLLOW-UP Month 18. Weight (kg) will be estimated using the Tanita Tetrapolar Bioimpedance Scale with Octaelectrodes BC 601®. Before the consultation, participants will be instructed to attend the meeting wearing light clothing, avoiding heavy meals, fasting from water for 1 hour, and from caffeine for 24 hours prior to the exam. For the measurements, participants will be asked to remove their shoes and empty their bladder. Subsequently, the individual will be asked to step onto the scale. Data will be collected in the morning to mitigate any type of recurring body water fluctuation throughout the day.
Trial sites (1)
Facility
City
Region
Status
Federal University of São Paulo (UNIFESP)
Santos
São Paulo
More Federal University of São Paulo trials in Brazil
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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