Personalized Behavioral Nutrition Intervention in Older AAs With T2D

Study Overview
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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.

Detailed Description
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: ADA-based nutrition education with digital self-monitoring
* Behavioral: Personalized Behavioral Nutrition (PBN) intervention group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>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<br>* Diabetes nutrition education developed by the American Diabetes Association with digital self-monitoring for diet and physical activity<br>|
| Experimental: Intervention group<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control | Change in Glycemic control as assessed by HbA1C levels | Baseline, 4-week, 8-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolites profiles | 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) | Baseline, 4-week | 
| Lipids profiles | Change in lipids profiles (LDL, HDL, total cholesterol, triglycerides) as assessed by serum lipids profiling | Baseline, 4-week, 8-week | 
| Weight | Change in weight as assessed by the Withings electronic scale | Baseline, 4-week, 8-week | 
| Dietary intake | Daily dietary intake as measured by the Fitbit food log | Over the 4-week | 
| Physical activity | Daily steps taken as measured by the Fitbit wristband | Over the 4-week | 
| In-home self-monitoring of blood glucose | Daily blood glucose level as measured by wireless glucometer | Over the 4-week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Personalized behavioral nutrition, Pilot study, Hybrid randomized clinical trial, Older Asian Americans, Metabolomics approach