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.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03579420

Enrollment

226

Registered

2018-07-06

Start date

2018-03-01

Completion date

2024-04-01

Last updated

2021-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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.

Interventions

BEHAVIORALBrief lifestyle program

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

BEHAVIORALConventional lifestyle program

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Contacts

Primary ContactMattreo Monami, MD

matteo.monami@unifi.it3384027484

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026