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.

Condition

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)

Arm Groups

ArmDescriptionAssigned Intervention
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
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

Recruiting Locations

The University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
Contact:
Jisook Ko, PhD
210-567-5554
koj1@uthscsa.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Jisook Ko, PhD
210-567-5554
koj1@uthscsa.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.