Purpose

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.

Category

IRB Number
20200055HU
NCT Number
NCT04533659
Open to Enrollment
Yes
Sponsor
The University of Texas Health Science Center at San Antonio -



Study Contact

Jisook Ko
(210) 567-5554
koj1@uthscsa.edu

Principal Investigator
Jisook Ko

Jisook Ko
(210) 567-5554
koj1@uthscsa.edu



Eligibility

Eligible Ages
Over 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    1. Self-identified as Asian Americans (Chinese, Korean, or South Asian)
    2. Age 65 years or older
    3. Residing in the Bexar County area
    4. Diagnosed with type 2 diabetes; A1C ≥7.5% within 6 months of screening
    5. Expressing a willingness to participate in all aspects of the study over its full course
    6. Possession of a smartphone

Exclusion Criteria

    1. Unable to give informed consent
    2. People under another diet regime that is different from the ADA recommended diet
    3. 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)
    4. Hematological condition that would affect A1C assay, e.g., hemolytic anemia, sickle cell anemia

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)
Condition
  • Type 2 Diabetes

    • Arm Groups

    ArmDescriptionIntervention
    Experimental

    Intervention group

    		This group will receive 4-week personalized behavioral nutrition intervention with digital self-monitoring for diet and blood glucose and diabetes nutrition education. Participants will discuss the personalized nutrition change goals and recommendations based on metabolic profiling for assessing dietary patterns.
  • 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

    • Active Comparator

    Control group

    		This group will receive 4-week diabetes nutrition education with digital self-monitoring for diet and blood glucose.
  • 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

    •