MedTrace Logo

Impact of Telemonitoring on Metabolic Variables in Severe Obesity

NCT05786092 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-03-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Istituto Auxologico Italiano

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2024-09-30
Completion
2024-10-15

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05786092 on ClinicalTrials.gov