Trials / Completed
CompletedNCT04533659
Personalized Behavioral Nutrition Intervention in Older AAs With T2D
Personalized Behavioral Nutrition Intervention in Older Asian Americans With Type 2 Diabetes
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- The University of Texas Health Science Center at San Antonio · Academic / Other
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
This study is designed with two aims: 1. to determine if PBN intervention improves glycemic control, weight control, and metabolites profiles compared with the control group. 2. to identify significant factors that influence the relative effectiveness of PBN and the relative acceptability of PBN.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | ADA-based nutrition education with digital self-monitoring | Diabetes nutrition education developed by the American Diabetes Association with digital self-monitoring for diet and physical activity |
| BEHAVIORAL | Personalized Behavioral Nutrition (PBN) intervention group | Personalized behavioral nutrition intervention consisting of digital self-monitoring for diet and physical activity, personalized nutrition change goal and recommendation, and diabetes nutrition education developed by ADA |
Timeline
- Start date
- 2020-08-01
- Primary completion
- 2025-07-25
- Completion
- 2025-07-25
- First posted
- 2020-08-31
- Last updated
- 2025-08-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04533659. Inclusion in this directory is not an endorsement.