Personalized Behavioral Nutrition Intervention in Older Asian Americans With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Glycemic control
研究概览
简要总结
The rapid growth rate and unique challenges as a new immigrant group call for a better understanding of the social and health needs of the older Asian Americans (AAs) population. Overwhelming numbers of AAs, a fast-growing first-generation immigrant group, suffer from type 2 diabetes (T2D) and its consequences of poorly controlled blood glucose. For the older AAs, there are higher prevalence rates, worse diabetes control, and higher rates of complications due to limited English proficiency and health literacy. Despite the evidence concerning the effects of dietary interventions on glycemic control by well-controlled feeding studies in mainstream Americans, a lack of clinical trials of culturally tailored interventions often imposes serious barriers to translate and implement such fruitful and innovative approaches in individuals from ethnic minority communities such as AAs.
The proposed study will use a randomized, controlled design with a sample of 60 AAs aged 65 years or older. Metabolomics methodologies will be incorporated into this research to provide a global picture of metabolites' responses to personalized behavioral nutrition (PBN) intervention. The study results will obtain the necessary information to conduct a meaningful community-based clinical trial to test the effectiveness of PBN in improving dietary patterns and glycemic control in older AAs.
详细描述
This study is designed with two aims:
- to determine if PBN intervention improves glycemic control, weight control, and metabolites profiles compared with the control group.
- to identify significant factors that influence the relative effectiveness of PBN and the relative acceptability of PBN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-identified as Asian Americans (Chinese, Korean, or South Asian)
- •Age 65 years or older
- •Residing in the Bexar County area
- •Diagnosed with type 2 diabetes; A1C ≥7.5% within 6 months of screening
- •Expressing a willingness to participate in all aspects of the study over its full course
- •Possession of a smartphone
排除标准
- •Unable to give informed consent
- •People under another diet regime that is different from the ADA recommended diet
- •Physical or mental health conditions that could limit active participation in the study (e.g., severe illness, blindness in both eyes, severe immobility, psychiatric diseases)
- •Hematological condition that would affect A1C assay, e.g., hemolytic anemia, sickle cell anemia
结局指标
主要结局
Glycemic control
时间窗: Baseline, 4-week, 8-week
Change in Glycemic control as assessed by HbA1C levels
次要结局
- Weight(Baseline, 4-week, 8-week)
- Dietary intake(Over the 4-week)
- Lipids profiles(Baseline, 4-week, 8-week)
- In-home self-monitoring of blood glucose(Over the 4-week)
- Metabolites profiles(Baseline, 4-week)
- Physical activity(Over the 4-week)