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임상시험 NCT07145684 (OSanDiaBé)은(는) 제2형 당뇨병에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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카드 뷰
Culturally Tailored Nutrition Therapy to Improve Dietary Adherence of Type 2 Diabetes Patients in Benin, Africa (OSanDiaBé)
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임상시험 NCT07145684 (OSanDiaBé)은(는) 제2형 당뇨병에 대해 알아보는 중재연구입니다. 현재 상태는 대상자모집전이며, 2025년 10월 2일부터 참여 신청이 가능합니다. 60명의 참여자를 모집할 예정입니다. University of Arizona이(가) 진행하는 이 연구는 2026년 10월 30일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 8월 28일에 갱신되었습니다.
간단한 개요
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?
상세한 설명
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.
공식 제목
Effectiveness of a Culturally Tailored Medical Nutrition Therapy for African Patients With Type 2 Diabetes: The Objectif Santé Diabète Benin (OSanDiaBé) Trial
질환/상태
제2형 당뇨병기타 연구 식별자
- OSanDiaBé
- STUDY00002233
- K01TW012422 (NIH (미국 국립보건원) 보조금/계약)
NCT 번호
실제 연구 시작일
2025-10-02
최신 업데이트 게시
2025-08-28
예상 연구 완료일
2026-10-30
계획된 등록 인원
60
연구종류
중재연구
단계/상
해당 없음
상태
대상자모집전
키워드
Type 2 Diabetes
Cultural Adaptation
Medical Nutrition Therapy
Dietary Adherence
Africa
Cultural Adaptation
Medical Nutrition Therapy
Dietary Adherence
Africa
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
이중맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적OSanDiaBé 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. |
비개입Individual 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. | 해당 없음 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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. |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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. |
적격성 기준
연령대
성인, 노인
최소 연령
40 Years
참여 가능한 성별
전체
- 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 Health연구 책임자
Halimatou Alaofe, 책임연구자, Associate Professor, University of Arizona
연구 대표 연락처
연락처: Halimatou Alaofe, Ph.D, 520-369-6356, [email protected]
연락처: John Ehiri, PhD, 520-626-1355, [email protected]
1 1개국에 임상시험 장소
Littoral Department
University of Abomey-Calavi, Cotonou, Littoral Department, Benin
Waliou Amoussa-Hounkpatin, PhD, 연락처, +229 97 05 20 20, [email protected]
Halimatou Alaofe, PhD, 연락처, 5203696356, [email protected]