Type 2 DiabetesNCT04533659
Personalized Behavioral Nutrition Intervention in Older AAs With T2D
A study testing ADA-based nutrition education with digital self-monitoring and Personalized Behavioral Nutrition (PBN) intervention group in people with Type 2 Diabetes, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- ADA-based nutrition education with digital self-monitoring and Personalized Behavioral Nutrition (PBN) intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 25 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- ADA-based nutrition education with digital self-monitoring, Personalized Behavioral Nutrition (PBN) intervention group
- Keywords
- Personalized behavioral nutrition, Pilot study, Hybrid randomized clinical trial, Older Asian Americans, Metabolomics approach
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADA-based nutrition education with digital self-monitoringBehavioural
Diabetes nutrition education developed by the American Diabetes Association with digital self-monitoring for diet and physical activity
Personalized Behavioral Nutrition (PBN) intervention groupBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | This group will receive 4-week diabetes nutrition education with digital self-monitoring for diet and blood glucose. Receives: Behavioral: ADA-based nutrition education with digital self-monitoring |
| Intervention group | Experimental | 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. Receives: Behavioral: Personalized Behavioral Nutrition (PBN) intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
Change in Glycemic control as assessed by HbA1C levels
Measured: Baseline, 4-week, 8-week
Secondary outcomes (6)
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)
Measured: Baseline, 4-week
Lipids profiles
Change in lipids profiles (LDL, HDL, total cholesterol, triglycerides) as assessed by serum lipids profiling
Measured: Baseline, 4-week, 8-week
Weight
Change in weight as assessed by the Withings electronic scale
Measured: Baseline, 4-week, 8-week
Dietary intake
Daily dietary intake as measured by the Fitbit food log
Measured: Over the 4-week
Physical activity
Daily steps taken as measured by the Fitbit wristband
Measured: Over the 4-week
In-home self-monitoring of blood glucose
Daily blood glucose level as measured by wireless glucometer
Measured: Over the 4-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Aug 2020
- Primary completion25 Jul 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Rutgers Asian Resource Center for Minority Aging Research (RCMAR)
- Responsible party
- Sponsor
- Investigators
- Jisook Ko, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533659
- Sponsor's protocol ID
- HSC20200055H
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2020
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34160184
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Behavioral Nutrition Intervention in Older Asian Americans With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04533659
- Acronym / sponsor ID
- HSC20200055H
- Conditions
- Type 2 Diabetes
- Keywords
- Personalized behavioral nutrition, Pilot study, Hybrid randomized clinical trial, Older Asian Americans, Metabolomics approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- The Rutgers Asian Resource Center for Minority Aging Research (RCMAR)
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: ADA-based nutrition education with digital self-monitoringThis group will receive 4-week diabetes nutrition education with digital self-monitoring for diet and blood glucose. |
| Intervention group | Experimental | Behavioral: Personalized Behavioral Nutrition (PBN) intervention groupThis 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADA-based nutrition education with digital self-monitoringDiabetes nutrition education developed by the American Diabetes Association with digital self-monitoring for diet and physical activity | Behavioural | Control group |
| Personalized Behavioral Nutrition (PBN) intervention groupPersonalized 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 | Behavioural | Intervention group |
Primary outcome
Glycemic control
Time frame: Baseline, 4-week, 8-week
Change in Glycemic control as assessed by HbA1C levels
6 secondary outcomes
Metabolites profiles
Time frame: Baseline, 4-week
Lipids profiles
Time frame: Baseline, 4-week, 8-week
Weight
Time frame: Baseline, 4-week, 8-week
Dietary intake
Time frame: Over the 4-week
Physical activity
Time frame: Over the 4-week
In-home self-monitoring of blood glucose
Time frame: Over the 4-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Derived from this study: PubMed 34160184Ko 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jisook Ko, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADA-based nutrition education with digital self-monitoring and Personalized Behavioral Nutrition (PBN) intervention group in people with Type 2 Diabetes, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (time frame: Baseline, 4-week, 8-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04533659, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.