Efficacy of a Brief Lifestyle Intervention in Type 2 Diabetes, Compared With a Longer Group Educational Program
NCT ID: NCT03579420
Last Updated: 2021-01-13
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
226 participants
INTERVENTIONAL
2018-03-01
2024-04-01
Brief Summary
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1. A brief group program, with three weekly sessions
2. A longer group program, with six weekly sessions, which has been routinely used for the management of type 2 diabetic patients in this hospital for several years.
The aim is that of demonstrating the non-inferiority of the new brief, and more sustainable, program, in comparison with the more traditional approach.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Brief lifestyle program
3-session lifestyle group intervention program focussed on physical activity and eating habits, using interactive methods and a behavioral approach
Brief lifestyle program
3-session program for modification of lifestyle habits (exercise and diet)
Traditional lifestyle longer program
6-session lifestyle group intervention program focussed on physical activity and eating habits, using traditional lessons and interactive methods
Conventional lifestyle program
6-session program for modification of lifestyle habits (exercise and diet)
Interventions
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Brief lifestyle program
3-session program for modification of lifestyle habits (exercise and diet)
Conventional lifestyle program
6-session program for modification of lifestyle habits (exercise and diet)
Eligibility Criteria
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Inclusion Criteria
* HbA1c between 48 and 75 mmol/mol
Exclusion Criteria
* Heart failure (NYHA Class III or IV)
* Foot ulcers or lower limb amputations
18 Years
75 Years
ALL
No
Sponsors
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Azienda Ospedaliero-Universitaria Careggi
OTHER
Responsible Party
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Edoardo Mannucci
Director, Diabetology
Locations
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Diabetologia AOU Careggi
Florence, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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bPEGT2
Identifier Type: -
Identifier Source: org_study_id
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