Effectiveness of a Culturally Tailored Medical Nutrition Therapy for African Patients With Type 2 Diabetes: The Objectif Santé Diabète Benin (OSanDiaBé) Trial
Effectiveness of a Culturally Tailored Medical Nutrition Therapy for African Patients With Type 2 Diabetes: The Objectif Santé Diabète Benin (OSanDiaBé) Trial
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 nutrition choices. The investigators hypothesize that participants receiving OSanDiaBé will demonstrate greater improvements in dietary adherence and greater reductions in HbA1c at 6 months compared with those receiving usual care. The investigators further hypothesize that these improvements will be maintained at 12 months following the end of active intervention contact.
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 care (wait-list control group) or (2) nutrition counseling with group-based education (intervention group). The intervention group will receive the OSanDiaBé resource package, which includes a workbook, and an Eating Plan based on the 4-A framework of food security. They will participate in four individual home sessions and eight group sessions in the first six months, with no contact between months six and twelve. The primary outcome will be the change in HbA1c levels, while secondary outcomes will include lipid profile, anthropometric measures, dietary adherence, diabetes self-efficacy, and diabetes-related quality of life. All outcomes will be assessed at baseline, 3, 6, and 12 months.
Inclusion Criteria
Exclusion criteria