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L'essai clinique NCT07145684 (OSanDiaBé) pour Diabète de type 2 est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Culturally Tailored Nutrition Therapy to Improve Dietary Adherence of Type 2 Diabetes Patients in Benin, Africa (OSanDiaBé)
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L'étude clinique NCT07145684 (OSanDiaBé) est un essai interventionnel pour Diabète de type 2. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 2 octobre 2025, avec un objectif de 60 participants. Dirigé par University of Arizona, l'essai devrait être terminé d'ici le 30 octobre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 28 août 2025.
Résumé succinct
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?
Description détaillée
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.
Titre officiel
Effectiveness of a Culturally Tailored Medical Nutrition Therapy for African Patients With Type 2 Diabetes: The Objectif Santé Diabète Benin (OSanDiaBé) Trial
Conditions
Diabète de type 2Autres identifiants de l'essai
- OSanDiaBé
- STUDY00002233
- K01TW012422 (Subvention/contrat NIH (É.-U.))
Numéro NCT
Date de début (réel)
2025-10-02
Dernière mise à jour publiée
2025-08-28
Date de fin (estimée)
2026-10-30
Inscription (estimée)
60
Type d'essai
Interventionnel
PHASE
N/A
Statut
Pas encore en recrutement
Mots clés
Type 2 Diabetes
Cultural Adaptation
Medical Nutrition Therapy
Dietary Adherence
Africa
Cultural Adaptation
Medical Nutrition Therapy
Dietary Adherence
Africa
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Double aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalOSanDiaBé 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. |
Aucune interventionIndividual 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. | N/A |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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. |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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. |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
40 Years
Sexes éligibles
Tous
- 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 HealthPartie responsable de l'essai
Halimatou Alaofe, Investigateur principal, Associate Professor, University of Arizona
Contact central de l'essai
Contact: Halimatou Alaofe, Ph.D, 520-369-6356, [email protected]
Contact: John Ehiri, PhD, 520-626-1355, [email protected]
1 Centres de l'essai dans 1 pays
Littoral Department
University of Abomey-Calavi, Cotonou, Littoral Department, Benin
Waliou Amoussa-Hounkpatin, PhD, Contact, +229 97 05 20 20, [email protected]
Halimatou Alaofe, PhD, Contact, 5203696356, [email protected]