Personalized Behavioral Nutrition for Type 2 Diabetes

YD
JK
Overseen ByJisook Ko, PhD
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center at San Antonio
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a personalized nutrition plan to help manage type 2 diabetes in older Asian Americans. By tailoring dietary advice to each individual, the researchers aim to improve blood sugar control and overall diet. Participants will either follow a general diabetes nutrition program or receive a customized plan, known as the Personalized Behavioral Nutrition (PBN) intervention, based on their metabolic profile. The trial seeks Asian Americans aged 65 or older living in Bexar County, diagnosed with type 2 diabetes, and who own a smartphone. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to more effective diabetes management strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude people on a diet different from the ADA recommended diet, so dietary changes might be required.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that personalized nutrition therapy, which considers individual health goals and cultural preferences, can safely and effectively manage type 2 diabetes. One study examined meal plans customized according to international diabetes guidelines and traditional eating habits. Participants found these plans easy to follow, and no major side effects occurred.

Changing eating habits plays a crucial role in managing type 2 diabetes, as these changes can help control blood sugar levels. Research suggests that these approaches are generally safe, with few or no negative side effects.

The personalized behavioral nutrition (PBN) approach in this study is in a "not applicable" phase, indicating it likely involves non-drug treatments. These treatments usually present fewer safety concerns than new medications, suggesting that this approach is likely safe and well-tolerated by participants.12345

Why are researchers excited about this trial?

Researchers are excited about Personalized Behavioral Nutrition (PBN) for Type 2 Diabetes because it offers a tailored approach that considers an individual's unique metabolic profile to guide dietary changes. Unlike standard treatments that often rely on generalized dietary advice, PBN focuses on personalized nutrition goals and recommendations, which could lead to more effective management of blood sugar levels. Additionally, the integration of digital self-monitoring tools allows participants to track their diet and glucose levels in real-time, potentially enhancing engagement and adherence to the treatment plan. This personalized and tech-driven strategy could revolutionize how we manage Type 2 Diabetes, making it more precise and user-friendly.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

This trial will compare two approaches to nutrition education for type 2 diabetes. The intervention group receives a personalized behavioral nutrition intervention, including personalized nutrition change goals and recommendations based on metabolic profiling. Research has shown that personalized nutrition plans, which consider individual health goals and cultural preferences, can help people with type 2 diabetes control their blood sugar levels. Studies have found that when these plans fit cultural needs, individuals manage their blood sugar more effectively. For example, a trial focusing on culturally tailored nutrition plans saw improvements in blood sugar levels. Another study indicated that personalized nutrition based on DNA affected blood sugar control over time. Overall, adjusting dietary advice to fit personal and cultural needs appears promising for better managing type 2 diabetes.13467

Who Is on the Research Team?

JK

Jisook Ko, PhD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for older Asian Americans aged 65 or above with type 2 diabetes, an A1C level of at least 7.5%, living in Bexar County, and who own a smartphone. Participants must be willing to engage fully in the study and not be on any special diets other than the ADA recommended diet.

Inclusion Criteria

Living in the Bexar County area
You have a smartphone.
I have type 2 diabetes with an A1C level of 7.5% or higher in the last 6 months.
See 3 more

Exclusion Criteria

I do not have any health conditions that would prevent me from fully participating in the study.
I do not have blood conditions like hemolytic or sickle cell anemia.
I am unable to understand and agree to the study's details on my own.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 4-week personalized behavioral nutrition intervention with digital self-monitoring for diet and blood glucose, and diabetes nutrition education.

4 weeks
Weekly virtual check-ins

Follow-up

Participants are monitored for changes in glycemic control, lipids profiles, weight, and metabolites profiles.

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • ADA-based nutrition education with digital self-monitoring
  • Personalized Behavioral Nutrition (PBN) intervention group
Trial Overview The study tests a Personalized Behavioral Nutrition (PBN) intervention against standard ADA-based nutrition education using digital self-monitoring tools. It aims to see if PBN can improve dietary habits and blood sugar control among older Asian Americans with type 2 diabetes.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment1 Intervention
Group II: Control groupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials
486
Recruited
92,500+

Asian Resource Center for Minority Aging Research (RCMAR)

Collaborator

Trials
1
Recruited
60+

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

Collaborator

Trials
1
Recruited
60+

Published Research Related to This Trial

Nutrition interventions for Chinese populations with type 2 diabetes, both in China and as immigrants, often follow intensive lifestyle programs and show improvements in blood glucose control, indicating their efficacy.
Cultural adaptation of these interventions is crucial for success, particularly in Western countries, yet there is a need for more community-based trials and better documentation of dietary behaviors to fully understand their impact.
Nutrition Interventions for Type 2 Diabetes in Chinese Populations: A Scoping Review.Deng, F., Zhang, A., Chan, C.[2020]
A survey of 837 healthcare providers across Mexico, Taiwan, and the United States showed that 61% believe the transcultural Diabetes Nutrition Algorithm (tDNA) Patient Algorithm Therapy (PATh) can help address challenges in implementing medical nutrition therapy (MNT) for diabetes.
The majority of respondents (91%) had a positive impression of tDNA-PATh, with 83% indicating they would adopt it, suggesting that this culturally sensitive tool could effectively enhance MNT implementation in diverse clinical settings.
The transcultural diabetes nutrition algorithm toolkit: survey and content validation in the United States, Mexico, and Taiwan.Hamdy, O., Marchetti, A., Hegazi, RA., et al.[2019]
There is no one-size-fits-all meal plan for people with diabetes; nutrition therapy must be tailored to each individual's health goals, preferences, and circumstances.
Effective nutrition interventions should focus on a variety of minimally processed, nutrient-dense foods and provide practical tools for sustainable behavior change in managing diabetes.
Nutrition therapy recommendations for the management of adults with diabetes.Evert, AB., Boucher, JL., Cypress, M., et al.[2022]

Citations

Personalized Behavioral Nutrition for Type 2 DiabetesResearch shows that personalized nutrition therapy, which considers individual health goals and cultural preferences, can improve blood sugar control in people ...
A Culturally-tailored Personalized Nutrition Intervention in ...This trial will assess the impact of a culturally tailored, personalized nutrition intervention on glycemic response to an oral glucose load (as measured by ...
Assessment of the impact of a personalised nutrition ...In this study we aimed to determine the impact of a DNA-personalised nutrition intervention in people with non-diabetic hyperglycaemia over 26 weeks.
Outcomes of Culturally Tailored Dietary Intervention in the ...Five culturally tailored dietary profiles were designed according to international diabetes guidelines and adjusted to traditional food habits.
Behavioral approaches to nutrition and eating patterns for ...Behavioral approaches to nutritional management of type 2 diabetes are likely to be most successful when a patient-centered model is adopted where treatment ...
Outcomes of Culturally Tailored Dietary Intervention in the ...Five culturally tailored dietary profiles were designed according to international diabetes guidelines and adjusted to traditional food habits.
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/34160184/
Personalized Behavioral Nutrition Among Older Asian ...Findings from this pilot study will inform future research for developing personalized nutrition interventions for people with Type 2 diabetes.
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