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Effectiveness of the Farsi Diabetes Self-management Education (FDSME) Program for People With Type 2 Diabetes

Effectiveness of the Farsi Diabetes Self-management Education Program for People With Type 2 Diabetes: Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01050803
Acronym
FDSME
Enrollment
280
Registered
2010-01-15
Start date
2009-08-31
Completion date
2011-04-30
Last updated
2024-04-10

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

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes Mellitus, Intervention studies, Program effectiveness

Brief 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. 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

Interventions

BEHAVIORALFDSME group

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.

BEHAVIORALFDSME

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.

Sponsors

Tehran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosed with type 2 diabetes (according to the WHO criteria) * Older than 18 years

Exclusion criteria

* Pregnancy * Unable to participate in a group program (for example, housebound or unable to communicate in Farsi) * Having reduced cognitive ability

Design outcomes

Primary

MeasureTime frame
HbA1cwithin 2 years
BMI2 years

Secondary

MeasureTime frame
Audit of Diabetes-Dependent Quality of Life (ADDQOL)two years

Outcome results

None listed

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