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

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

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 Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Brief lifestyle program; Behavioral: Conventional lifestyle program

• Study Type: Interventional
• Enrollment (Anticipated): 226
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mattreo Monami, MD; Phone Number: 3384027484; Email: matteo.monami@unifi.it

Study Locations

• Italy
  • Florence, Italy, 50134
    • Recruiting
    • Diabetologia AOU Careggi
    • Contact: Matteo Monami, MD; Phone Number: 3384027484; Email: matteo.monami@unifi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brief lifestyle program; 3-session lifestyle group intervention program focussed on physical activity and eating habits, using interactive methods and a behavioral approach	Behavioral: Brief lifestyle program; 3-session program for modification of lifestyle habits (exercise and diet)
Active Comparator: Traditional lifestyle longer program; 6-session lifestyle group intervention program focussed on physical activity and eating habits, using traditional lessons and interactive methods	Behavioral: Conventional lifestyle program; 6-session program for modification of lifestyle habits (exercise and diet)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c at 6 months		6 months
Treatment success at 6 months	HbA1c within predefined target without any increase in pharmacological therapy	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist circumference		6 months
Body Mass Index		6 months
Treatment success at 24 months	HbA1c within predefined target without any increase in pharmacological therapy	24 months
HbA1c at 24 months		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)	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)	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).	24 months
Body Mass Index		24 months
Waist circumference		24 months

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria Careggi

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: June 1, 2018
• First Submitted That Met QC Criteria: June 25, 2018
• First Posted (Actual): July 6, 2018

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: bPEGT2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No