Personalized Behavioral Nutrition Intervention in Older AAs With T2D

April 17, 2023 updated by: The University of Texas Health Science Center at San Antonio

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

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • The University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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

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

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

The Rutgers Asian Resource Center for Minority Aging Research (RCMAR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

August 24, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

August 31, 2020

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

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

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Type 2 Diabetes

Clinical Trials on ADA-based nutrition education with digital self-monitoring

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe