رادار التجارب AI | ||
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حالة التجربة السريرية NCT07145684 (OSanDiaBé) لـ داء السكري من النوع 2 هي لم يبدأ التجنيد بعد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
Culturally Tailored Nutrition Therapy to Improve Dietary Adherence of Type 2 Diabetes Patients in Benin, Africa (OSanDiaBé)
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ 'رادار التجارب AI' أن يساعدك؛ ما عليك سوى النقر على 'وصف الدراسة' لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT07145684 (OSanDiaBé) هي دراسة تدخُّلية لـداء السكري من النوع 2 وهي لم يبدأ التجنيد بعد. من المقرر أن يبدأ التسجيل في ١٠ ربيع الآخر ١٤٤٧ هـ لتجنيد ٦٠ مشاركًا. يقودها University of Arizona، ومن المتوقع اكتمالها بحلول ١٩ جمادى الأولى ١٤٤٨ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٥ ربيع الأول ١٤٤٧ هـ.
الملخص
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. It seeks to answer two main questions:
- Does the culturally tailored MNT lower HbA1c levels at 12 months compared to usual care?
- Does it improve dietary behaviors at 12 months compared to usual care?
وصف مفصل
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 weekly presentations, 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.
العنوان الرسمي
Effectiveness of a Culturally Tailored Medical Nutrition Therapy for African Patients With Type 2 Diabetes: The Objectif Santé Diabète Benin (OSanDiaBé) Trial
الحالات الطبية
داء السكري من النوع 2معرّفات دراسة أخرى
- OSanDiaBé
- STUDY00002233
- K01TW012422 (منحة/عقد NIH الأمريكي)
NCT معرّف
تاريخ البدء (فعلي)
2025-10-02
آخر تحديث مُنشور
2025-08-28
تاريخ الاكتمال (المقدر)
2026-10-30
عدد المشاركين المخطط لهم
٦٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
لم يبدأ التجنيد بعد
الكلمات الرئيسية
Type 2 Diabetes
Cultural Adaptation
Medical Nutrition Therapy
Dietary Adherence
Africa
Cultural Adaptation
Medical Nutrition Therapy
Dietary Adherence
Africa
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
مزدوج
مجموعات/التدخلات
| مجموعة المشاركين/مجموعة | تَدَخُّل/علاج |
|---|---|
تجريبيةOSanDiaBé intervention 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 weekly presentations, a workbook, and an Eating Plan based on the 4-A framework of food security. | A Culturally Tailored Medical Nutrition Therapy This MNT intervention combines evidence-based menu plans based on the 4A framework of food security with individual nutrition counseling and group diabetes education. |
بدون تدخلIndividual standard care 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. | غ/م |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
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. |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
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. | 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. We will use WHO classifications 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 | We 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. |
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
40 Years
الجنس المؤهل
الكل
- 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.
- 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).
University of ArizonaFogarty International Center of the National Institute of Healthالجهة المسؤولة عن الدراسة
Halimatou Alaofe, المحقق الرئيسي, Associate Professor, University of Arizona
جهة اتصال مركزية للدراسة
جهة اتصال: Halimatou Alaofe, Ph.D, 520-369-6356, [email protected]
جهة اتصال: John Ehiri, PhD, 520-626-1355, [email protected]
1 مواقع الدراسة في 1 بلدان
Littoral Department
University of Abomey-Calavi, Cotonou, Littoral Department, Benin
Waliou Amoussa-Hounkpatin, PhD, جهة اتصال, +229 97 05 20 20, [email protected]
Halimatou Alaofe, PhD, جهة اتصال, 5203696356, [email protected]