Personalized Behavioral Nutrition Intervention in Older AAs With T2D

NCT04533659 | Completed DMC

• 1 other identifier: HSC20200055H
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Keywords

Personalized behavioral nutrition; Pilot study; Hybrid randomized clinical trial; Older Asian Americans; Metabolomics approach

Outcome Measures

Primary Outcomes (1)

• Glycemic control

  Change in Glycemic control as assessed by HbA1C levels

  Baseline, 4-week, 8-week

Secondary Outcomes (6)

• Metabolites profiles

  Baseline, 4-week

• Lipids profiles

  Baseline, 4-week, 8-week

• Weight

  Baseline, 4-week, 8-week

• Dietary intake

  Over the 4-week

• Physical activity

  Over the 4-week

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Intervention group

EXPERIMENTAL

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

Interventions

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

Control group

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

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• The Rutgers Asian Resource Center for Minority Aging Research (RCMAR): collaborator

Study Sites (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Ko J, Wang J, Du Y, Jiwani R, Li C. Personalized Behavioral Nutrition Among Older Asian Americans: Study Protocol. Nurs Res. 2021 Jul-Aug 01;70(4):317-322. doi: 10.1097/NNR.0000000000000514.

  PMID: 34160184 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jisook Ko, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 31, 2020
• Study Start: August 1, 2020
• Primary Completion: July 25, 2025
• Study Completion: July 25, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

US (1)