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.
1 other identifier
interventional
226
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Mar 2018
Longer than P75 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2018
CompletedFirst Submitted
Initial submission to the registry
June 1, 2018
CompletedFirst Posted
Study publicly available on registry
July 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedJanuary 13, 2021
January 1, 2021
4.6 years
June 1, 2018
January 12, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
HbA1c at 6 months
6 months
Treatment success at 6 months
HbA1c within predefined target without any increase in pharmacological therapy
6 months
Secondary Outcomes (9)
Treatment success at 24 months
24 months
HbA1c at 24 months
24 months
MEditerranean DIet adherence LITErature-based (MEDI-LITE) questionnaire scores
24 months
International Physical Activity Questionnaire-Short Form (IPAQ-SF) scores
24 months
Well-being Enquiry in Diabetics (WED) questionnaire total score
24 months
- +4 more secondary outcomes
Study Arms (2)
Brief lifestyle program
EXPERIMENTAL3-session lifestyle group intervention program focussed on physical activity and eating habits, using interactive methods and a behavioral approach
Traditional lifestyle longer program
ACTIVE COMPARATOR6-session lifestyle group intervention program focussed on physical activity and eating habits, using traditional lessons and interactive methods
Interventions
3-session program for modification of lifestyle habits (exercise and diet)
6-session program for modification of lifestyle habits (exercise and diet)
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- HbA1c between 48 and 75 mmol/mol
You may not qualify if:
- Axis I Mental Disorders
- Heart failure (NYHA Class III or IV)
- Foot ulcers or lower limb amputations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diabetologia AOU Careggi
Florence, 50134, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Diabetology
Study Record Dates
First Submitted
June 1, 2018
First Posted
July 6, 2018
Study Start
March 1, 2018
Primary Completion
October 1, 2022
Study Completion
April 1, 2024
Last Updated
January 13, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share