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

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

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2024-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

Brief lifestyle program

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

Conventional lifestyle program

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

Conventional lifestyle program

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero-Universitaria Careggi

OTHER

Sponsor Role lead

Responsible Party

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Edoardo Mannucci

Director, Diabetology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Diabetologia AOU Careggi

Florence, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Mattreo Monami, MD

Role: CONTACT

3384027484

Facility Contacts

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Matteo Monami, MD

Role: primary

3384027484

Other Identifiers

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bPEGT2

Identifier Type: -

Identifier Source: org_study_id

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