Impact of Therapeutic Education for Type 2 Diabetic Patients During Ramadan.
1 other identifier
interventional
85
1 country
1
Brief Summary
This randomized controlled trial evaluates the impact of therapeutic education, with or without personalized coaching, on clinical and biological outcomes in patients with type 2 diabetes during Ramadan fasting. Participants were randomly assigned to three groups: Control (usual care), Education Only, and Education plus Coaching. All received a 30-minute pre-Ramadan education session; the Education plus Coaching group also had follow-up telephone consultations. Outcomes included HbA1c, fasting blood glucose, cholesterol, BMI, and blood pressure measured before and after Ramadan. The study aims to assess whether structured education and ongoing coaching help patients fast safely and maintain better metabolic control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2019
Shorter than P25 for not_applicable
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 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2019
CompletedFirst Submitted
Initial submission to the registry
August 1, 2025
CompletedFirst Posted
Study publicly available on registry
August 8, 2025
CompletedAugust 8, 2025
August 1, 2025
3 months
August 1, 2025
August 1, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
HbA1c Level after ramadan
the level of HbA1c after ramadan
From enrollment (two weeks before ramadan219) to two weeks after ramadan 2019
HbA1c level after ramadan
6 to 8 weeks
Study Arms (3)
education and coaching
ACTIVE COMPARATOReducation before ramadan fasting and during ramadan
education only
ACTIVE COMPARATOReducation before ramadan fasting only
Controle
NO INTERVENTIONNo intervention
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetic patients taking oral treatment who intended to fast during Ramadan and agreed to participate in the study.
You may not qualify if:
- Patients with severe comorbidities (renal failure, recent coronary disease, cognitive impairement) and those classified as very high risk for fasting
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fattouma Bourguiba University Hospital
Monastir, 5000, Tunisia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Semir Nouira, Medical Doctor
Fattouma bourguiba university hospital of Monastir
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
August 1, 2025
First Posted
August 8, 2025
Study Start
March 10, 2019
Primary Completion
June 15, 2019
Study Completion
June 15, 2019
Last Updated
August 8, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share