Eating Window and Sleep Disorders on Glycemic Control, Cardiovascular Risk, and Weight Loss

Federal University of São Paulo

Status: Enrolling

Conditions: Hypertension; Obesity and Type 2 Diabetes; Type 2 Diabetes Mellitus (T2DM); Cardiovascular Diseases

Treatments: Behavioral: Comparison of eating windows intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06735859

82942424.9.1001.5505

Details and patient eligibility

About

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.

Full description

The study will be conducted at the Endocrinology and Hypertension Clinic of the São José do Rio Preto Medical School between 2026 and 2027, with the objective of collecting comprehensive data for an in-depth analysis of the participants. Eligible individuals will be randomly assigned to two intervention groups. Participants in the first group will follow a daytime eating window (7:00 a.m. to 7:00 p.m.), while those in the second group will follow a nighttime eating window (12:00 p.m. to 12:00 a.m.). Nutritional consultations will be conducted individually at five assessment points: Month 0 (baseline), Month 6 (end of first intervention phase), Month 9 (end of washout), Month 15 (end of second intervention phase), and Month 18 (follow-up). Each consultation will last approximately one hour per participant, and all participants will receive appointment reminders via phone or WhatsApp.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: Adults >18 years < 80 years; Diagnosis of obesity, diabetes, and hypertension; 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Daytime eating window (7 am - 7 pm)

Active Comparator group

Description:

Participants will be instructed to follow the assigned eating window for a period of 6 months. In the daytime eating window, there will also be encouragement for sleep hygiene practices.

Treatment:

Behavioral: Comparison of eating windows intervention

Nighttime eating window (12 pm - 12 am)

Active Comparator group

Description:

Participants will be instructed to follow the assigned eating window for a period of 6 months.

Treatment:

Behavioral: Comparison of eating windows intervention