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

Azienda Ospedaliero-Universitaria Careggi226 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

226

Conditions

Diabetes Mellitus, Type 2

Interventions

Brief lifestyle programBEHAVIORAL

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

Conventional lifestyle programBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Diabetologia AOU Careggi

Florence, Italy

RECRUITING

Outcomes

Primary Outcomes

HbA1c at 6 months

Time frame: 6 months

Treatment success at 6 months

HbA1c within predefined target without any increase in pharmacological therapy

Time frame: 6 months

Secondary Outcomes

Treatment success at 24 months

HbA1c within predefined target without any increase in pharmacological therapy

Time frame: 24 months

HbA1c at 24 months

Time frame: 24 months

MEditerranean DIet adherence LITErature-based (MEDI-LITE) questionnaire scores

14-item questionnaire with scores ranging from 0 (low adherence) to 18 (high adherence)

Time frame: 24 months

International Physical Activity Questionnaire-Short Form (IPAQ-SF) scores

7-item questionnaire with scores ranging from 0 (no activity) to 7 (high activity)

Time frame: 24 months

Well-being Enquiry in Diabetics (WED) questionnaire total score

50-item questionnaire measuring diabetes-specific health-related quality of life, with scores ranging from 0 (low) to 50 (high). Only total score will be used in analysis 1. Mannucci E, et al., Diabetes Nutr Metab 9: 89-102, 1996).

Time frame: 24 months

Body Mass Index

Time frame: 6 months

Waist circumference

Central Contacts

Mattreo Monami, MD

CONTACT

3384027484 matteo.monami@unifi.it

Data from ClinicalTrials.gov

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