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

Azienda Ospedaliero-Universitaria Careggi

Status: Unknown

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Brief lifestyle program; Behavioral: Conventional lifestyle program

Study type: Interventional

Funder types: Other

Identifiers

NCT03579420

bPEGT2

Details and patient eligibility

About

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.

Enrollment: 226 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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226 participants in 2 patient groups

Brief lifestyle program

Experimental group

Description:

3-session lifestyle group intervention program focussed on physical activity and eating habits, using interactive methods and a behavioral approach

Treatment:

Behavioral: Brief lifestyle program

Traditional lifestyle longer program

Active Comparator group

Description:

6-session lifestyle group intervention program focussed on physical activity and eating habits, using traditional lessons and interactive methods

Treatment:

Behavioral: Conventional lifestyle program