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

Study Overview
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Brief Summary
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The study will compare two different programs for lifestyle intervention in type 2 diabetes: A brief group program, with three weekly sessions 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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Brief lifestyle program
* Behavioral: Conventional lifestyle program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 |  | 6 months | 
| Waist circumference |  | 6 months | 
| Body Mass Index |  | 24 months | 
| Waist circumference |  | 24 months |