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Efficacy of a Brief Lifestyle Intervention in Type 2 Diabetes, Compared With a Longer Group Educational Program

NCT03579420 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2021-01-13

No results posted yet for this study

Summary

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

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

BEHAVIORAL

Brief lifestyle program

3-session program for modification of lifestyle habits (exercise and diet)

BEHAVIORAL

Conventional lifestyle program

6-session program for modification of lifestyle habits (exercise and diet)

Sponsors & Collaborators

  • Azienda Ospedaliero-Universitaria Careggi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2022-10-01
Completion
2024-04-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03579420 on ClinicalTrials.gov