Impact of Telemonitoring on Metabolic Variables in Severe Obesity

Not Applicable

Recruiting

• Conditions: Severe Obesity
• Interventions: Device: Telemonitoring

• Registration Number: NCT05786092
• Lead Sponsor: Istituto Auxologico Italiano

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-15
• Status Verified: 2023-03
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-15
• Last Update Submitted: 2023-03-15
• Study First Posted: 2023-03-27
• Last Update Posted: 2023-03-27
• Primary Completion: 2024-09
• Study Completion: 2024-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment	Telemonitoring	-

Primary Outcome Measures

Name	Time	Method
+ dropout rate at month 11 of patients followed-up by a telemedicine methodology with that of a traditional outpatient visit follow-up.	12 months	Percentage of patients still in care at month 11 after discharge in each of the two subgroups.

Secondary Outcome Measures

Name	Time	Method
amount of weight loss at month 11 in patients followed-up by telemedicine with that registered in patients followed-up by traditional outpatient visits.	12 months	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.

Trial Locations

Locations (1)

Istituto Auxologico Italiano; 🇮🇹 Oggebbio, VCO, Italy