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Personalized Behavioral Nutrition Intervention in Older AAs With T2D

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ClinicalTrials.gov Identifier: NCT04533659
Recruitment Status : Recruiting
First Posted : August 31, 2020
Last Update Posted : July 29, 2021
Sponsor:
Collaborator:
Asian Resource Center for Minority Aging Research (RCMAR)
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Study Description
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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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: ADA-based nutrition education with digital self-monitoring Behavioral: Personalized Behavioral Nutrition (PBN) intervention group Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Personalized Behavioral Nutrition Intervention in Older Asian Americans With Type 2 Diabetes
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 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
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Glycemic control [ Time Frame: Baseline, 4-week, 8-week ]
    Change in Glycemic control as assessed by HbA1C levels


Secondary Outcome Measures :
  1. 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)

  2. Lipids profiles [ Time Frame: Baseline, 4-week, 8-week ]
    Change in lipids profiles (LDL, HDL, total cholesterol, triglycerides) as assessed by serum lipids profiling

  3. Weight [ Time Frame: Baseline, 4-week, 8-week ]
    Change in weight as assessed by the Withings electronic scale

  4. Dietary intake [ Time Frame: Over the 4-week ]
    Daily dietary intake as measured by the Fitbit food log

  5. Physical activity [ Time Frame: Over the 4-week ]
    Daily steps taken as measured by the Fitbit wristband

  6. In-home self-monitoring of blood glucose [ Time Frame: Over the 4-week ]
    Daily blood glucose level as measured by wireless glucometer


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04533659


Contacts
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Contact: Jisook Ko, PhD 210-567-5554 koj1@uthscsa.edu
Contact: Yan Du, PhD 210-567-2170 duy@uthscsa.edu

Locations
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United States, Texas
The University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Jisook Ko, PhD    210-567-5554    koj1@uthscsa.edu   
Sub-Investigator: Yan Du, PhD         
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Asian Resource Center for Minority Aging Research (RCMAR)
Investigators
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Principal Investigator: Jisook Ko, PhD The University of Texas Health Science Center at San Antonio
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT04533659    
Other Study ID Numbers: HSC20200055H
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: July 29, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The University of Texas Health Science Center at San Antonio:
Personalized behavioral nutrition
Pilot study
Hybrid randomized clinical trial
Older Asian Americans
Metabolomics approach
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases