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Completed

NCT Number: NCT04533659

Personalized Behavioral Nutrition Intervention in Older AAs With T2D

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

ADA-based nutrition education with digital self-monitoring

Behavioral

Diabetes nutrition education developed by the American Diabetes Association with digital self-monitoring for diet and physical activity

Personalized Behavioral Nutrition (PBN) intervention group

Behavioral

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

Primary outcomes

  1. Glycemic control

    Time frame: Baseline, 4-week, 8-week

    Change in Glycemic control as assessed by HbA1C levels

Secondary outcomes

  1. Metabolites profiles

    Time frame: Baseline, 4-week

    Change in 302 targeted metabolites profiles (e.g. Aconitic acid, Citric acid, Glycolic acid, Homovanillic acid, 2-ET-3-OH-Propionate, 3-OH-Isobutyrate, 3-OH-Isovalerate, 2-3-OH-Propionate, and Uracil)

  2. Lipids profiles

    Time frame: Baseline, 4-week, 8-week

    Change in lipids profiles (LDL, HDL, total cholesterol, triglycerides) as assessed by serum lipids profiling

  3. Weight

    Time frame: Baseline, 4-week, 8-week

    Change in weight as assessed by the Withings electronic scale

  4. Dietary intake

    Time frame: Over the 4-week

    Daily dietary intake as measured by the Fitbit food log

  5. Physical activity

    Time frame: Over the 4-week

    Daily steps taken as measured by the Fitbit wristband

  6. In-home self-monitoring of blood glucose

    Time frame: Over the 4-week

    Daily blood glucose level as measured by wireless glucometer

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • The Rutgers Asian Resource Center for Minority Aging Research (RCMAR)

Registry information

Official study title

Personalized Behavioral Nutrition Intervention in Older Asian Americans With Type 2 Diabetes

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Aug 31, 2020
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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