Personalized Behavioral Nutrition Intervention in Older AAs With T2D

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Personalized Behavioral Nutrition (PBN) intervention group; Behavioral: ADA-based nutrition education with digital self-monitoring

• Registration Number: NCT04533659
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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.

Detailed 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.

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2020-08-24
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Personalized Behavioral Nutrition (PBN) 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.
Control group	ADA-based nutrition education with digital self-monitoring	This group will receive 4-week diabetes nutrition education with digital self-monitoring for diet and blood glucose.

Primary Outcome Measures

Name	Time	Method
Glycemic control	Baseline, 4-week, 8-week	Change in Glycemic control as assessed by HbA1C levels

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States