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NCT03579420 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03579420
Other study ID # bPEGT2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date April 1, 2024

Study information
Verified date January 2021
Source Azienda Ospedaliero-Universitaria Careggi
Contact Mattreo Monami, MD
Phone 3384027484
Email matteo.monami@unifi.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 226
Est. completion date April 1, 2024
Est. primary completion date October 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Brief lifestyle program
3-session program for modification of lifestyle habits (exercise and diet)
• Conventional lifestyle program
6-session program for modification of lifestyle habits (exercise and diet)

Locations
Country Name City State
Italy Diabetologia AOU Careggi Florence

Sponsors (1)
Lead Sponsor Collaborator
Azienda Ospedaliero-Universitaria Careggi

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c at 6 months 6 months
Primary Treatment success at 6 months HbA1c within predefined target without any increase in pharmacological therapy 6 months
Secondary Treatment success at 24 months HbA1c within predefined target without any increase in pharmacological therapy 24 months
Secondary HbA1c at 24 months 24 months
Secondary MEditerranean DIet adherence LITErature-based (MEDI-LITE) questionnaire scores 14-item questionnaire with scores ranging from 0 (low adherence) to 18 (high adherence) 24 months
Secondary International Physical Activity Questionnaire-Short Form (IPAQ-SF) scores 7-item questionnaire with scores ranging from 0 (no activity) to 7 (high activity) 24 months
Secondary 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). 24 months
Secondary Body Mass Index 6 months
Secondary Waist circumference 6 months
Secondary Body Mass Index 24 months
Secondary Waist circumference 24 months
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