Severe Obesity Clinical Trial
— teleobOfficial title:
The Role of Home Telemonitoring in the Evaluation of Patients With Severe Obesity After a Period of Residential Metabolic Rehabilitation.
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | October 15, 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Istituto Auxologico Italiano | Oggebbio | VCO |
Lead Sponsor | Collaborator |
---|---|
Istituto Auxologico Italiano |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | changes in blood pressure registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up. | Variation in blood pressure between the time of discharge and 11 months in patients undergoing the two different strategies in studies | 12 months | |
Other | changes in heart rate registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up. | Variation in heart rate between the time of discharge and 11 months in patients undergoing the two different strategies in studies | 12 months | |
Other | changes in oxygen saturation registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up. | Variation in oxygen saturation between the time of discharge and 11 months in patients undergoing the two different strategies in studies | 12 months | |
Other | changes in blood glucose registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up. | Variation in blood glucose between the time of discharge and 11 months in patients undergoing the two different strategies in studies | 12 months | |
Primary | + dropout rate at month 11 of patients followed-up by a telemedicine methodology with that of a traditional outpatient visit follow-up. | Percentage of patients still in care at month 11 after discharge in each of the two subgroups. | 12 months | |
Secondary | amount of weight loss at month 11 in patients followed-up by telemedicine with that registered in patients followed-up by traditional outpatient visits. | Percentage of patients with weight loss of at least 5% and percentage of patients with weight loss between 0% and 5% at month 11 in each of the two subgroups. | 12 months |
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