An interventional study of A culturally tailored medical nutrition therapy in Type 2 Diabetes, sponsored by University of Arizona. Active, not recruiting at 1 site in Benin. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by University of Arizona · Not applicable, Interventional, and Treatment
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's enrollment of 64 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of Arizona is the lead sponsor of 476 studies on the registry; 88 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 30 (59%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Objectif Sante Diabète Bénin (OSanDiaBé) intervention group will participate in four individual home sessions and eight group sessions in the first six months, with no contact between months six and twelve. They will receive the OSanDiaBé resource package, which includes a workbook and an Eating Plan based on the 4-A framework of food security.
Behavioral: A culturally tailored medical nutrition therapy
The Individual standard care arm will be a wait-list control group who will receive standard care, including blood glucose management and general lifestyle advice, and will access the OSanDiaBe program at the end of the intervention for equitable treatment.
This MNT intervention combines evidence-based menu plans based on the 4A framework of food security with individual nutrition counseling and group diabetes education.
Hemoglobin A1C (HbA1C)
A hemoglobin A1C (HbA1C) test is a blood test that shows the average level of blood glucose over the past two to three months.
Time frame: HbA1c will be assessed at baseline, 3, 6, and 12 months.
Adherence to dietary recommendations
Dietary adherence will be assessed using the modified UK Diabetes and Diet Questionnaire (UKDDQ), which consists of 22 items on dietary patterns. Responses indicate food consumption frequency and are coded as follows: A=5 (healthy), B=4 (healthy), C=3 (less healthy), D=2 (less healthy), E=1 (unhealthy), F=0 (unhealthy). Final scores range from 0 to 5, with higher scores indicating better dietary habits.
Time frame: Dietary adherence will be assessed at baseline, 3, 6, and 12 months.
Weight
Weight will be measured in kilograms to the nearest 0.1 kg with a standard weighing scale (Hana model, China) while ensuring the participants wear light clothing and no shoes.
Time frame: Weight will be assessed at baseline, 3, 6, and 12 months.
Height
Height will be measured with a stadiometer to the nearest 0.1 cm.
Time frame: Height will be assessed at baseline, 3, 6, and 12 months.
Body mass index
The BMI (Body Mass Index) will be calculated using the formula: weight (kg) divided by height (m) squared. WHO classifications will be used for adult BMI: underweight (under 18.5 kg/m2), normal weight (18.5 to 24.9), overweight (25 to 29.9), and obese (30 or more).
Time frame: BMI will be assessed at baseline, 3, 6, and 12 months.
Waist circumference
The waist circumference will be measured at the umbilicus using a non-elastic tape measure while the participant stood upright, recorded in centimeters.
Time frame: Waist circumference will be assessed at baseline, 3, 6, and 12 months.
Blood pressure
The blood pressure will be measured with a sphygmomanometer.
Time frame: Blood pressure will be assessed at baseline, 3, 6, and 12 months.
Lipid profile
Lipid profile will include triglycerides (TG), low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C).
Time frame: Lipid profile will be assessed at baseline, 3, 6, and 12 months.
Behavioral outcomes
The investigators will use the Academy's Evidence-Based Nutrition Practice Guidelines (AEBNPG) for MNT to track behavioral changes in meal planning, food preparation, and physical activity, rating adherence on a scale of 1 (never) to 5 (consistently).
Time frame: Behavioral outcomes will be assessed at baseline, 3, 6, and 12 months.
Plan to share: Yes — Data obtained from this study may be shared with qualified researchers who have an academic interest in type 2 diabetes. Any data or samples provided will be coded and will not include any personal health information (PHI). Before sharing the data, the request must receive approval, and all necessary agreements (such as a material transfer agreement) must be in place.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data requests can be submitted starting 9 months after article publication, and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Access criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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