Type 2 Diabetes MellitusFDSMENCT01050803
Effectiveness of the Farsi Diabetes Self-management Education (FDSME) Program for People With Type 2 Diabetes
A study testing FDSME group and FDSME in people with Type 2 Diabetes Mellitus, run by Tehran University of Medical Sciences.
Trial summary
To evaluate the effectiveness of the Farsi diabetes self-management education program on psychosocial, lifestyle, and clinical measures in people with newly diagnosed people with type 2 diabetes and those with already-diagnosed type two diabetes who had received little self-management education. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- FDSME group and FDSME
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Apr 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes (according to the WHO criteria)
- Older than 18 years
Who cannot join
- Pregnancy
- Unable to participate in a group program (for example, housebound or unable to communicate in Farsi)
- Having reduced cognitive ability
About this study
Official title: Effectiveness of the Farsi Diabetes Self-management Education Program for People With Type 2 Diabetes: Randomized Controlled Trial
To evaluate the effectiveness of the Farsi diabetes self-management education program on psychosocial, lifestyle, and clinical measures in people with newly diagnosed people with type 2 diabetes and those with already-diagnosed type two diabetes who had received little self-management education. The development of the program was guided by an innovative process of intervention planning: Intervention Mapping.
Read the detailed description
For designing the management program, we will use Intervention Mapping (IM) framework for systematically developing the theory and evidence based program.
Based on IM approach, this study will have seven phases:
Step 1: needs assessment (Development the problem analysis: health, quality of life, behavior, environment).
Step 2: We will develop proximal program objectives with a multidisciplinary expert panel of participants.
Step 3: After identification of the proximal program objectives, the next step will be to select theoretical methods and practical strategies based on evidence for alternative methods.
Step 4: The forth step of the program development will comprise of composing program materials and pre-testing these materials with a sample of patients at a diabetic outpatient clinic.
Step 5: By involving the future program facilitators (health care workers at outpatient clinics) a linkage system will be foreseen.
Step 6: planning for evaluation Step 7: Randomized Clinical Trial
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- FDSME group, FDSME
- Keywords
- Diabetes Mellitus, Intervention studies, Program effectiveness
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDSME groupBehavioural
In the intervention group, diabetes education sessions which are designed based on the "Intervention Mapping" will be interactive and reflection in between sessions will be encouraged. Group-based problem-solving exercises will be used during the sessions. Participants receive feedback from peers and healthcare professionals at the following sessions.
FDSMEBehavioural
In the intervention group, sessions which are designed based on the "Intervention Mapping" will be interactive and reflection in between sessions will be encouraged. Group-based problem-solving exercises will be used during the sessions. Participants receive feedback from peers and healthcare professionals at the following sessions.
| Study group | Role | What they receive |
|---|---|---|
| FDSME group | Experimental | In the FDSME group, sessions will be held interactive; and reflection in between sessions will be encouraged. Group-based problem-solving exercises will be used during the sessions. Participants receive feedback from peers and healthcare professionals at the following sessions. Receives: Behavioral: FDSME group |
| Control group | Active comparator | Not described Receives: Behavioral: FDSME |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: within 2 years
BMI
Measured: 2 years
Secondary outcomes (1)
Audit of Diabetes-Dependent Quality of Life (ADDQOL)
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startAug 2009
- Primary completionMar 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050803
- Sponsor's protocol ID
- FDSME
- Acronym
- FDSME
- Status last verified
- May 2016
- First submitted
- 13 Jan 2010
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Farsi Diabetes Self-management Education Program for People With Type 2 Diabetes: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01050803
- Acronym / sponsor ID
- FDSME / FDSME
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Intervention studies, Program effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 15 Jan 2010 (estimated)
- 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.
To evaluate the effectiveness of the Farsi diabetes self-management education program on psychosocial, lifestyle, and clinical measures in people with newly diagnosed people with type 2 diabetes and those with already-diagnosed type two diabetes who had received little self-management education. The development of the program was guided by an innovative process of intervention planning: Intervention Mapping.
Detailed description
For designing the management program, we will use Intervention Mapping (IM) framework for systematically developing the theory and evidence based program.
Based on IM approach, this study will have seven phases:
Step 1: needs assessment (Development the problem analysis: health, quality of life, behavior, environment).
Step 2: We will develop proximal program objectives with a multidisciplinary expert panel of participants.
Step 3: After identification of the proximal program objectives, the next step will be to select theoretical methods and practical strategies based on evidence for alternative methods.
Step 4: The forth step of the program development will comprise of composing program materials and pre-testing these materials with a sample of patients at a diabetic outpatient clinic.
Step 5: By involving the future program facilitators (health care workers at outpatient clinics) a linkage system will be foreseen.
Step 6: planning for evaluation Step 7: Randomized Clinical Trial
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FDSME group | Experimental | Behavioral: FDSME groupIn the FDSME group, sessions will be held interactive; and reflection in between sessions will be encouraged. Group-based problem-solving exercises will be used during the sessions. Participants receive feedback from peers and healthcare professionals at the following sessions. |
| Control group | Active comparator | Behavioral: FDSME |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with type 2 diabetes (according to the WHO criteria)
- Older than 18 years
Key exclusion criteria (3 listed)
- Pregnancy
- Unable to participate in a group program (for example, housebound or unable to communicate in Farsi)
- Having reduced cognitive ability
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 |
|---|---|---|
| FDSME groupIn the intervention group, diabetes education sessions which are designed based on the "Intervention Mapping" will be interactive and reflection in between sessions will be encouraged. Group-based problem-solving exercises will be used during the sessions. Participants receive feedback from peers and healthcare professionals at the following sessions. | Behavioural | FDSME group |
| FDSMEIn the intervention group, sessions which are designed based on the "Intervention Mapping" will be interactive and reflection in between sessions will be encouraged. Group-based problem-solving exercises will be used during the sessions. Participants receive feedback from peers and healthcare professionals at the following sessions. | Behavioural | Control group |
Primary outcome
HbA1c
Time frame: within 2 years
BMI
Time frame: 2 years
1 secondary outcome
Audit of Diabetes-Dependent Quality of Life (ADDQOL)
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing FDSME group and FDSME in people with Type 2 Diabetes Mellitus, run by Tehran University of Medical Sciences.
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: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: within 2 years). 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 10 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.