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| ID | Type | Description | Link |
|---|---|---|---|
| K01TW012422 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Fogarty International Center of the National Institute of Health | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSanDiaBé intervention | Experimental | 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. |
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| Individual standard care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A culturally tailored medical nutrition therapy | Behavioral | This MNT intervention combines evidence-based menu plans based on the 4A framework of food security with individual nutrition counseling and group diabetes education. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | HbA1c will be assessed at baseline, 3, 6, and 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Waliou Amoussa-Hounkpatin, PhD | Université d'Abomey-Calavi | Principal Investigator |
| Edward Bedric, PhD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Abomey-Calavi | Cotonou | Littoral Department | Benin |
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.
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 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).
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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. | 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. | 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). | 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. | Waist circumference will be assessed at baseline, 3, 6, and 12 months. |
| Blood pressure | The blood pressure will be measured with a sphygmomanometer. | 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). | 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). | Behavioral outcomes will be assessed at baseline, 3, 6, and 12 months. |
| D004700 | Endocrine System Diseases |