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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Brief lifestyle program
Conventional lifestyle program
Sponsored by
Azienda Ospedaliero-Universitaria Careggi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Diabetologia AOU CareggiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Brief lifestyle program

Traditional lifestyle longer program

Arm Description

3-session lifestyle group intervention program focussed on physical activity and eating habits, using interactive methods and a behavioral approach

6-session lifestyle group intervention program focussed on physical activity and eating habits, using traditional lessons and interactive methods

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Treatment success at 24 months
HbA1c within predefined target without any increase in pharmacological therapy
HbA1c at 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)
International Physical Activity Questionnaire-Short Form (IPAQ-SF) scores
7-item questionnaire with scores ranging from 0 (no activity) to 7 (high activity)
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).
Body Mass Index
Waist circumference
Body Mass Index
Waist circumference

Full Information

First Posted
June 1, 2018
Last Updated
January 12, 2021
Sponsor
Azienda Ospedaliero-Universitaria Careggi
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1. Study Identification

Unique Protocol Identification Number
NCT03579420
Brief Title
Efficacy of a Brief Lifestyle Intervention in Type 2 Diabetes, Compared With a Longer Group Educational Program
Official Title
Efficacy of a Brief Group Program Versus a Longer Structured Program for Therapeutic Education of Patients With Type 2 Diabetes.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero-Universitaria Careggi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
226 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brief lifestyle program
Arm Type
Experimental
Arm Description
3-session lifestyle group intervention program focussed on physical activity and eating habits, using interactive methods and a behavioral approach
Arm Title
Traditional lifestyle longer program
Arm Type
Active Comparator
Arm Description
6-session lifestyle group intervention program focussed on physical activity and eating habits, using traditional lessons and interactive methods
Intervention Type
Behavioral
Intervention Name(s)
Brief lifestyle program
Intervention Description
3-session program for modification of lifestyle habits (exercise and diet)
Intervention Type
Behavioral
Intervention Name(s)
Conventional lifestyle program
Intervention Description
6-session program for modification of lifestyle habits (exercise and diet)
Primary Outcome Measure Information:
Title
HbA1c at 6 months
Time Frame
6 months
Title
Treatment success at 6 months
Description
HbA1c within predefined target without any increase in pharmacological therapy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Treatment success at 24 months
Description
HbA1c within predefined target without any increase in pharmacological therapy
Time Frame
24 months
Title
HbA1c at 24 months
Time Frame
24 months
Title
MEditerranean DIet adherence LITErature-based (MEDI-LITE) questionnaire scores
Description
14-item questionnaire with scores ranging from 0 (low adherence) to 18 (high adherence)
Time Frame
24 months
Title
International Physical Activity Questionnaire-Short Form (IPAQ-SF) scores
Description
7-item questionnaire with scores ranging from 0 (no activity) to 7 (high activity)
Time Frame
24 months
Title
Well-being Enquiry in Diabetics (WED) questionnaire total score
Description
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).
Time Frame
24 months
Title
Body Mass Index
Time Frame
6 months
Title
Waist circumference
Time Frame
6 months
Title
Body Mass Index
Time Frame
24 months
Title
Waist circumference
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mattreo Monami, MD
Phone
3384027484
Email
matteo.monami@unifi.it
Facility Information:
Facility Name
Diabetologia AOU Careggi
City
Florence
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matteo Monami, MD
Phone
3384027484
Email
matteo.monami@unifi.it

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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