NCT05786092

Impact of Telemonitoring on Metabolic Variables in Severe Obesity

The Role of Home Telemonitoring in the Evaluation of Patients With Severe Obesity After a Period of Residential Metabolic Rehabilitation.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Istituto Auxologico Italiano · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare, in a population of severely obese patients, two different kinds of follow-up after discharge from in-hospital rehabilitation programme. The main questions addressed are: * primary outcome: comparing the dropout rate at month 11 of patients followed-up by a telemedicine methodology with that of a traditional outpatient visit follow-up. * secondary outcome: comparing the amount of weight loss at month 11 in patients followed-up by telemedicine with that registered in patients followed-up by traditional outpatient visits. Participants are given a set of instruments (scale, activity tracker, automatic blood pressure monitor, oxymeter, and glucometer) and asked to measure vital parameters following a predetermined schedule for one year. Subjects are asked to engage in regular physical activity and follow the nutritional guidelines received at the moment of discharge from hospital.

Conditions

• Severe Obesity

Interventions

Type	Name	Description
DEVICE	Telemonitoring	Monitoring of the required parameters by means of the data provided by the devices used by patients. The data (weight, body composition, blood pressure, oxygen saturation, physical activity, heart rate and blood glucose) collected according to the predetermined schedule are then saved in a cloud accessible to researchers.

Timeline

• Start date: 2020-09-15
• Primary completion: 2024-09-01
• Completion: 2024-10-15
• First posted: 2023-03-27
• Last updated: 2023-03-27

Locations

1 site across 1 country: Italy