Personalized Behavioral Nutrition Intervention in Older AAs With T2D

The University of Texas System (UT)

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Behavioral: Personalized Behavioral Nutrition (PBN) intervention group; Behavioral: ADA-based nutrition education with digital self-monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT04533659

HSC20200055H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Control group

Active Comparator group

Description:

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

Treatment:

Behavioral: ADA-based nutrition education with digital self-monitoring

Intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Personalized Behavioral Nutrition (PBN) intervention group