Efficacy of a Brief Group Program Versus a Longer Structured Program for Therapeutic Education of Patients With Type 2 Diabetes.

Azienda Ospedaliero-Universitaria Careggi1 site in 1 country226 target enrollmentMarch 1, 2018

ConditionsDiabetes Mellitus, Type 2

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes Mellitus, Type 2
Sponsor: Azienda Ospedaliero-Universitaria Careggi
Enrollment: 226
Locations: 1
Primary Endpoint: Treatment success at 6 months
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study will compare two different programs for lifestyle intervention in type 2 diabetes:

A brief group program, with three weekly sessions
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.

Registry

clinicaltrials.gov

Start Date

March 1, 2018

End Date

April 1, 2024

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Azienda Ospedaliero-Universitaria Careggi

Responsible Party

Principal Investigator

Edoardo Mannucci

Director, Diabetology

Azienda Ospedaliero-Universitaria Careggi

Eligibility Criteria

Inclusion Criteria

•Type 2 diabetes
•HbA1c between 48 and 75 mmol/mol

Exclusion Criteria

•Axis I Mental Disorders
•Heart failure (NYHA Class III or IV)
•Foot ulcers or lower limb amputations

Outcomes

Primary Outcomes

Treatment success at 6 months

Time Frame: 6 months

HbA1c within predefined target without any increase in pharmacological therapy

HbA1c at 6 months

Time Frame: 6 months

Secondary Outcomes

Treatment success at 24 months(24 months)
Well-being Enquiry in Diabetics (WED) questionnaire total score(24 months)
Waist circumference(24 months)
International Physical Activity Questionnaire-Short Form (IPAQ-SF) scores(24 months)
Body Mass Index(24 months)
HbA1c at 24 months(24 months)
MEditerranean DIet adherence LITErature-based (MEDI-LITE) questionnaire scores(24 months)