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

March 15, 2023 updated by: Istituto Auxologico Italiano

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • VCO
      • Oggebbio, VCO, Italy, 28824
        • Recruiting
        • Istituto Auxologico Italiano
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment
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.
No Intervention: control

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amount of weight loss at month 11 in patients followed-up by telemedicine with that registered in patients followed-up by traditional outpatient visits.
Time Frame: 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.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in blood pressure registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up.
Time Frame: 12 months
Variation in blood pressure between the time of discharge and 11 months in patients undergoing the two different strategies in studies
12 months
changes in heart rate registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up.
Time Frame: 12 months
Variation in heart rate between the time of discharge and 11 months in patients undergoing the two different strategies in studies
12 months
changes in oxygen saturation registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up.
Time Frame: 12 months
Variation in oxygen saturation between the time of discharge and 11 months in patients undergoing the two different strategies in studies
12 months
changes in blood glucose registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up.
Time Frame: 12 months
Variation in blood glucose between the time of discharge and 11 months in patients undergoing the two different strategies in studies
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2020

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

October 15, 2024

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

March 15, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18C020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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