Effectiveness of a Culturally Tailored Medical Nutrition Therapy for African Patients With Type 2 Diabetes: The Objectif Santé Diabète Benin (OSanDiaBé) Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Hemoglobin A1C (HbA1C)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
OSanDiaBé 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 a workbook and an Eating Plan based on the 4-A framework of food security.
干预措施: A culturally tailored medical nutrition therapy (Behavioral)
Individual 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.
结局指标
主要结局
Hemoglobin A1C (HbA1C)
时间窗: HbA1c will be assessed at baseline, 3, 6, and 12 months.
A hemoglobin A1C (HbA1C) test is a blood test that shows the average level of blood glucose over the past two to three months.
次要结局
- Adherence to dietary recommendations(Dietary adherence will be assessed at baseline, 3, 6, and 12 months.)
- Weight(Weight will be assessed at baseline, 3, 6, and 12 months.)
- Body mass index(BMI will be assessed at baseline, 3, 6, and 12 months.)
- Height(Height will be assessed at baseline, 3, 6, and 12 months.)
- Waist circumference(Waist circumference will be assessed at baseline, 3, 6, and 12 months.)
- Blood pressure(Blood pressure will be assessed at baseline, 3, 6, and 12 months.)
- Lipid profile(Lipid profile will be assessed at baseline, 3, 6, and 12 months.)
- Behavioral outcomes(Behavioral outcomes will be assessed at baseline, 3, 6, and 12 months.)
研究者
Halimatou Alaofe
Associate Professor
University of Arizona