Diabetes Mellitus, Type 2NCT03579420
Efficacy of a Brief Lifestyle Intervention in Type 2 Diabetes, Compared With a Longer Group Educational Program
A study testing Brief lifestyle program and Conventional lifestyle program in people with Diabetes Mellitus, Type 2, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Brief lifestyle program and Conventional lifestyle program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2018to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- HbA1c between 48 and 75 mmol/mol
Who cannot join
- Axis I Mental Disorders
- Heart failure (NYHA Class III or IV)
- Foot ulcers or lower limb amputations
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Diabetologia AOU Careggi
Florence, 50134
Matteo Monami, MD, 3384027484, matteo.monami@unifi.it
About this study
Official title: Efficacy of a Brief Group Program Versus a Longer Structured Program for Therapeutic Education of Patients With Type 2 Diabetes.
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Brief lifestyle program, Conventional lifestyle program
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief lifestyle programBehavioural
3-session program for modification of lifestyle habits (exercise and diet)
Conventional lifestyle programBehavioural
6-session program for modification of lifestyle habits (exercise and diet)
| Study group | Role | What they receive |
|---|---|---|
| Brief lifestyle program | Experimental | 3-session lifestyle group intervention program focussed on physical activity and eating habits, using interactive methods and a behavioral approach Receives: Behavioral: Brief lifestyle program |
| Traditional lifestyle longer program | Active comparator | 6-session lifestyle group intervention program focussed on physical activity and eating habits, using traditional lessons and interactive methods Receives: Behavioral: Conventional lifestyle program |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c at 6 months
Measured: 6 months
Treatment success at 6 months
HbA1c within predefined target without any increase in pharmacological therapy
Measured: 6 months
Secondary outcomes (9)
Treatment success at 24 months
HbA1c within predefined target without any increase in pharmacological therapy
Measured: 24 months
HbA1c at 24 months
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 24 months
Body Mass Index
Measured: 6 months
Waist circumference
Measured: 6 months
Body Mass Index
Measured: 24 months
Waist circumference
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start1 Mar 2018
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edoardo Mannucci, Azienda Ospedaliero-Universitaria Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579420
- Sponsor's protocol ID
- bPEGT2
- Status last verified
- Jan 2021
- First submitted
- 1 Jun 2018
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Brief Group Program Versus a Longer Structured Program for Therapeutic Education of Patients With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT03579420
- Acronym / sponsor ID
- bPEGT2
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 6 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief lifestyle program | Experimental | Behavioral: Brief lifestyle program3-session lifestyle group intervention program focussed on physical activity and eating habits, using interactive methods and a behavioral approach |
| Traditional lifestyle longer program | Active comparator | Behavioral: Conventional lifestyle program6-session lifestyle group intervention program focussed on physical activity and eating habits, using traditional lessons and interactive methods |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes
- HbA1c between 48 and 75 mmol/mol
Key exclusion criteria (3 listed)
- Axis I Mental Disorders
- Heart failure (NYHA Class III or IV)
- Foot ulcers or lower limb amputations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief lifestyle program3-session program for modification of lifestyle habits (exercise and diet) | Behavioural | Brief lifestyle program |
| Conventional lifestyle program6-session program for modification of lifestyle habits (exercise and diet) | Behavioural | Traditional lifestyle longer program |
Primary outcome
HbA1c at 6 months
Time frame: 6 months
Treatment success at 6 months
Time frame: 6 months
HbA1c within predefined target without any increase in pharmacological therapy
9 secondary outcomes
Treatment success at 24 months
Time frame: 24 months
HbA1c at 24 months
Time frame: 24 months
MEditerranean DIet adherence LITErature-based (MEDI-LITE) questionnaire scores
Time frame: 24 months
International Physical Activity Questionnaire-Short Form (IPAQ-SF) scores
Time frame: 24 months
Well-being Enquiry in Diabetics (WED) questionnaire total score
Time frame: 24 months
Body Mass Index
Time frame: 6 months
Waist circumference
Time frame: 6 months
Body Mass Index
Time frame: 24 months
Waist circumference
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief lifestyle program and Conventional lifestyle program in people with Diabetes Mellitus, Type 2, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mattreo Monami, MD (3384027484, matteo.monami@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c at 6 months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.