Personalized Behavioral Nutrition Intervention in Older AAs With T2D

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2025-07-25

Brief Summary

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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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Detailed Description

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control group

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

Group Type ACTIVE_COMPARATOR

ADA-based nutrition education with digital self-monitoring

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Personalized Behavioral Nutrition (PBN) intervention group

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No