Impact of Telemonitoring on Metabolic Variables in Severe Obesity

NCT ID: NCT05786092

Last Updated: 2023-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2024-10-15

Brief Summary

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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

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Conditions

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Severe Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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treatment

Group Type EXPERIMENTAL

Telemonitoring

Intervention Type DEVICE

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.

control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Auxologico Italiano

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Istituto Auxologico Italiano

Oggebbio, VCO, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Massimo Scacchi

Role: CONTACT

+390323514301

Facility Contacts

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Sara P. Mambrini

Role: primary

+390323514512

Other Identifiers

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18C020

Identifier Type: -

Identifier Source: org_study_id

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