Personalized Behavioral Nutrition Intervention in Older AAs With T2D

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04533659
• Other study ID #: HSC20200055H
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: March 2025

Study information

• Verified date: April 2023
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Jisook Ko, PhD
• Phone: 210-567-5554
• Email: koj1[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2025
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• 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
• 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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	The Rutgers Asian Resource Center for Minority Aging Research (RCMAR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control	Change in Glycemic control as assessed by HbA1C levels	Baseline, 4-week, 8-week
Secondary	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
Secondary	Lipids profiles	Change in lipids profiles (LDL, HDL, total cholesterol, triglycerides) as assessed by serum lipids profiling	Baseline, 4-week, 8-week
Secondary	Weight	Change in weight as assessed by the Withings electronic scale	Baseline, 4-week, 8-week
Secondary	Dietary intake	Daily dietary intake as measured by the Fitbit food log	Over the 4-week
Secondary	Physical activity	Daily steps taken as measured by the Fitbit wristband	Over the 4-week
Secondary	In-home self-monitoring of blood glucose	Daily blood glucose level as measured by wireless glucometer	Over the 4-week