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

Not Applicable

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT03579420
• Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-06-25
• Study First Posted: 2018-07-06
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-13
• Primary Completion: 2022-10-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 226

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Treatment success at 6 months	6 months	HbA1c within predefined target without any increase in pharmacological therapy
HbA1c at 6 months	6 months

Secondary Outcome Measures

Name	Time	Method
Treatment success at 24 months	24 months	HbA1c within predefined target without any increase in pharmacological therapy
Well-being Enquiry in Diabetics (WED) questionnaire total score	24 months	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).
Waist circumference	24 months
International Physical Activity Questionnaire-Short Form (IPAQ-SF) scores	24 months	7-item questionnaire with scores ranging from 0 (no activity) to 7 (high activity)
Body Mass Index	24 months
HbA1c at 24 months	24 months
MEditerranean DIet adherence LITErature-based (MEDI-LITE) questionnaire scores	24 months	14-item questionnaire with scores ranging from 0 (low adherence) to 18 (high adherence)

Trial Locations

Locations (1)

Diabetologia AOU Careggi; 🇮🇹 Florence, Italy