- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04533659
Personalized Behavioral Nutrition Intervention in Older AAs With T2D
Personalized Behavioral Nutrition Intervention in Older Asian Americans With Type 2 Diabetes
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78229
- Recruiting
- The University of Texas Health Science Center at San Antonio
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control group
This group will receive 4-week diabetes nutrition education with digital self-monitoring for diet and blood glucose.
|
Diabetes nutrition education developed by the American Diabetes Association with digital self-monitoring for diet and physical activity
|
Experimental: 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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glycemic control
Time Frame: Baseline, 4-week, 8-week
|
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
Time Frame: 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)
|
Baseline, 4-week
|
Lipids profiles
Time Frame: Baseline, 4-week, 8-week
|
Change in lipids profiles (LDL, HDL, total cholesterol, triglycerides) as assessed by serum lipids profiling
|
Baseline, 4-week, 8-week
|
Weight
Time Frame: Baseline, 4-week, 8-week
|
Change in weight as assessed by the Withings electronic scale
|
Baseline, 4-week, 8-week
|
Dietary intake
Time Frame: Over the 4-week
|
Daily dietary intake as measured by the Fitbit food log
|
Over the 4-week
|
Physical activity
Time Frame: Over the 4-week
|
Daily steps taken as measured by the Fitbit wristband
|
Over the 4-week
|
In-home self-monitoring of blood glucose
Time Frame: Over the 4-week
|
Daily blood glucose level as measured by wireless glucometer
|
Over the 4-week
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC20200055H
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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