Impact of Telemonitoring on Metabolic Variables in Severe Obesity
NCT ID: NCT05786092
Last Updated: 2023-03-27
Study Results
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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UNKNOWN
NA
200 participants
INTERVENTIONAL
2020-09-15
2024-10-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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treatment
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.
control
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Istituto Auxologico Italiano
OTHER
Responsible Party
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Locations
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Istituto Auxologico Italiano
Oggebbio, VCO, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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18C020
Identifier Type: -
Identifier Source: org_study_id
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