Status:
NOT_YET_RECRUITING
Culturally Tailored Nutrition Therapy to Improve Dietary Adherence of Type 2 Diabetes Patients in Benin, Africa
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
Fogarty International Center of the National Institute of Health
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
40-65 years
Phase:
NA
Brief Summary
The clinical trial aims to assess the effectiveness of the Objectif Santé Diabète Benin (OSanDiaBé), a culturally tailored medical nutrition therapy (MNT), in enhancing diabetes management and nutriti...
Detailed Description
This study is a 12-month, parallel-group, randomized controlled trial involving individuals diagnosed with type 2 diabetes. Participants will be randomly assigned in a 1:1 ratio to either (1) usual ca...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- outpatient in one of the participating health centers
- be aged between 40 and 65 years old,
- have a confirmed diagnosis of T2D for a year or longer,
- with uncontrolled diabetes (HbA1c \>7%)
- able to read and write in French or a support who read and write in French
- self-identify as Beninese (born in Benin or have parents from Benin),
- willing to commit to the study and able to attend weekly meetings
- have family member support for behavioral change
- suitable for general diet and lifestyle advice (i.e., no complex diet needs; suitability determined by the referring healthcare provider)
- be willing to provide informed consent to participate.
- Exclusion criteria
- being pregnant, breastfeeding or planning pregnancy,
- participants with type 1 diabetes
- use of medication that might affect weight loss
- planning to travel before the end of the intervention
- have recent cardiovascular complications (e.g., myocardial infarction, stroke, and congestive heart failure),
- currently involved in a similar nutritional educational program (to avoid contamination bias).
- unable to provide consent (e.g., cognitive impairment).
Exclusion
Key Trial Info
Start Date :
October 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07145684
Start Date
October 2 2025
End Date
October 30 2026
Last Update
August 28 2025
Active Locations (1)
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1
University of Abomey-Calavi
Cotonou, Littoral Department, Benin