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

Primary Purpose

Severe Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Telemonitoring
Sponsored by
Istituto Auxologico Italiano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Severe Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Istituto Auxologico ItalianoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

treatment

control

Arm Description

Outcomes

Primary Outcome Measures

+ 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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 15, 2023
Last Updated
March 15, 2023
Sponsor
Istituto Auxologico Italiano
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1. Study Identification

Unique Protocol Identification Number
NCT05786092
Brief Title
Impact of Telemonitoring on Metabolic Variables in Severe Obesity
Acronym
teleob
Official Title
The Role of Home Telemonitoring in the Evaluation of Patients With Severe Obesity After a Period of Residential Metabolic Rehabilitation.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
October 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Auxologico Italiano

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Obesity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment
Arm Type
Experimental
Arm Title
control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Telemonitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
+ dropout rate at month 11 of patients followed-up by a telemedicine methodology with that of a traditional outpatient visit follow-up.
Description
Percentage of patients still in care at month 11 after discharge in each of the two subgroups.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
amount of weight loss at month 11 in patients followed-up by telemedicine with that registered in patients followed-up by traditional outpatient visits.
Description
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.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
changes in blood pressure registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up.
Description
Variation in blood pressure between the time of discharge and 11 months in patients undergoing the two different strategies in studies
Time Frame
12 months
Title
changes in heart rate registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up.
Description
Variation in heart rate between the time of discharge and 11 months in patients undergoing the two different strategies in studies
Time Frame
12 months
Title
changes in oxygen saturation registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up.
Description
Variation in oxygen saturation between the time of discharge and 11 months in patients undergoing the two different strategies in studies
Time Frame
12 months
Title
changes in blood glucose registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up.
Description
Variation in blood glucose between the time of discharge and 11 months in patients undergoing the two different strategies in studies
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Massimo Scacchi
Phone
+390323514301
Email
massimo.scacchi@unimi.it
Facility Information:
Facility Name
Istituto Auxologico Italiano
City
Oggebbio
State/Province
VCO
ZIP/Postal Code
28824
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara P. Mambrini
Phone
+390323514512
Email
s.mambrini@auxologico.it

12. IPD Sharing Statement

Learn more about this trial

Impact of Telemonitoring on Metabolic Variables in Severe Obesity

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