Clinical Trials Directory

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

TypeNameDescription
BEHAVIORALADA-based nutrition education with digital self-monitoringDiabetes nutrition education developed by the American Diabetes Association with digital self-monitoring for diet and physical activity
BEHAVIORALPersonalized Behavioral Nutrition (PBN) intervention groupPersonalized 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.