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Personalized Behavioral Nutrition Intervention in Older AAs With T2D

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ADA-based nutrition education with digital self-monitoring
Personalized Behavioral Nutrition (PBN) intervention group
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes focused on measuring Personalized behavioral nutrition, Pilot study, Hybrid randomized clinical trial, Older Asian Americans, Metabolomics approach

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at San AntonioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Intervention group

Arm Description

This group will receive 4-week diabetes nutrition education with digital self-monitoring for diet and blood glucose.

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.

Outcomes

Primary Outcome Measures

Glycemic control
Change in Glycemic control as assessed by HbA1C levels

Secondary Outcome Measures

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

Full Information

First Posted
August 24, 2020
Last Updated
April 17, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
The Rutgers Asian Resource Center for Minority Aging Research (RCMAR)
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1. Study Identification

Unique Protocol Identification Number
NCT04533659
Brief Title
Personalized Behavioral Nutrition Intervention in Older AAs With T2D
Official Title
Personalized Behavioral Nutrition Intervention in Older Asian Americans With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
The Rutgers Asian Resource Center for Minority Aging Research (RCMAR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Personalized behavioral nutrition, Pilot study, Hybrid randomized clinical trial, Older Asian Americans, Metabolomics approach

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
This group will receive 4-week diabetes nutrition education with digital self-monitoring for diet and blood glucose.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ADA-based nutrition education with digital self-monitoring
Intervention Description
Diabetes nutrition education developed by the American Diabetes Association with digital self-monitoring for diet and physical activity
Intervention Type
Behavioral
Intervention Name(s)
Personalized Behavioral Nutrition (PBN) intervention group
Intervention Description
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
Primary Outcome Measure Information:
Title
Glycemic control
Description
Change in Glycemic control as assessed by HbA1C levels
Time Frame
Baseline, 4-week, 8-week
Secondary Outcome Measure Information:
Title
Metabolites profiles
Description
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)
Time Frame
Baseline, 4-week
Title
Lipids profiles
Description
Change in lipids profiles (LDL, HDL, total cholesterol, triglycerides) as assessed by serum lipids profiling
Time Frame
Baseline, 4-week, 8-week
Title
Weight
Description
Change in weight as assessed by the Withings electronic scale
Time Frame
Baseline, 4-week, 8-week
Title
Dietary intake
Description
Daily dietary intake as measured by the Fitbit food log
Time Frame
Over the 4-week
Title
Physical activity
Description
Daily steps taken as measured by the Fitbit wristband
Time Frame
Over the 4-week
Title
In-home self-monitoring of blood glucose
Description
Daily blood glucose level as measured by wireless glucometer
Time Frame
Over the 4-week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jisook Ko, PhD
Phone
210-567-5554
Email
koj1@uthscsa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Du, PhD
Phone
210-567-2170
Email
duy@uthscsa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jisook Ko, PhD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jisook Ko, PhD
Phone
210-567-5554
Email
koj1@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Yan Du, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
34160184
Citation
Ko J, Wang J, Du Y, Jiwani R, Li C. Personalized Behavioral Nutrition Among Older Asian Americans: Study Protocol. Nurs Res. 2021 Jul-Aug 01;70(4):317-322. doi: 10.1097/NNR.0000000000000514.
Results Reference
derived

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Personalized Behavioral Nutrition Intervention in Older AAs With T2D

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