Impact of Telemonitoring on Metabolic Variables in Severe Obesity (teleob)

Istituto Auxologico Italiano

Status

Enrolling

Conditions

Severe Obesity

Treatments

Device: Telemonitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT05786092

18C020

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

BMI 38-60 kg/m2,
age between 18 and 65 years,
patient residing in Piedmont, Lombardy
Recent admission to San Giuseppe Hospital in Piancavallo for a period of residential rehabilitation.
Patient with wi-fi and/or mobile data connection at home.

Exclusion criteria

illiteracy
inability to engage in physical activity
psychiatric illnesses capable of impairing the proper use of the devices provided by telemonitoring
cognitive impairment, mental retardation
predictability of long periods of stay abroad
anticipation or planning of pregnancy during the year following discharge
legal protection