20 Participants Needed

Nutrition Intervention for Prediabetes

LA
Overseen ByLeslie Aguilar-Hernandez, BA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Cedars-Sinai Medical Center
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 the effectiveness of hands-on nutritional demos in helping individuals at risk for prediabetes maintain a healthy lifestyle. The main goal is to determine if these demos enhance the effectiveness and enjoyment of the Diabetes Prevention Program. Individuals may qualify for this trial if a doctor has identified them as having a moderate to high risk for prediabetes, a BMI of 25 or higher (23 if Asian), and specific blood sugar criteria. As an unphased trial, this study provides a unique opportunity to contribute to innovative approaches in diabetes prevention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this nutrition intervention is safe for prediabetes?

Research shows that lifestyle and dietary changes can be safe and beneficial for individuals with prediabetes. Studies have found that these adjustments can help some people return to normal blood sugar levels and reduce the risk of developing diabetes.

Reports indicate that most individuals can manage these changes well and maintain them without serious side effects. In fact, these lifestyle changes can even lower the risk of dying from any cause in people with prediabetes.

Overall, evidence suggests these changes are safe for most individuals. However, consulting a healthcare professional before starting any new treatment plan is always advisable.12345

Why are researchers excited about this trial?

Most treatments for prediabetes focus on medications or lifestyle changes like exercise and general diet improvements. However, the Nutrition Intervention is unique because it specifically tailors dietary strategies to manage blood sugar levels more effectively. Researchers are excited about this approach because it could offer a personalized way to prevent the progression to type 2 diabetes, potentially offering a more sustainable and natural method of managing prediabetes compared to standard medication-based treatments. By focusing on nutrition, this intervention may help individuals make long-term lifestyle changes that can significantly impact their health outcomes.

What evidence suggests that this nutrition intervention is effective for prediabetes?

Research has shown that changing diet can help manage prediabetes. For example, one study found that after three years, fewer people who changed their diet developed diabetes compared to those who did not. Another study found that early changes in eating habits reduced the risk of dying from any cause by 18% in people with prediabetes. Additionally, personalized meal plans have helped control blood sugar levels, which is important for prediabetes. Overall, changing what and how much one eats can greatly improve health for those at risk for diabetes. Participants in this trial will engage in a nutrition intervention to explore its feasibility and impact on prediabetes management.26789

Who Is on the Research Team?

YC

Yelba Castellon-Lopez, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals at moderate to high risk of prediabetes or diagnosed with it in the last year, as confirmed by specific blood sugar levels. Participants must have a BMI of 25+ (23+ if Asian), not have type 1 or type 2 diabetes, and be enrolled in the Diabetes Prevention Program.

Inclusion Criteria

My BMI is 25 or higher (23 if I'm Asian).
My blood sugar levels indicate I have prediabetes.
I do not have type 1 or type 2 diabetes.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Nutritional Intervention

Participants undergo a 7-week nutritional intervention with hands-on cooking demonstrations to enhance the DPP curriculum

7 weeks
Weekly sessions (in-person and virtual options available)

Follow-up

Participants are monitored for retention and changes in dietary habits, food insecurity, and quality of life indicators

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Nutrition Intervention

Trial Overview

The study tests a nutrition intervention within the Diabetes Prevention Program at a health center in Los Angeles. It involves hands-on nutritional demonstrations aimed at helping patients who are at-risk for prediabetes.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: DPP Clinic ParticipantsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials
523
Recruited
165,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Citations

Effectiveness of Personalized Nutrition on Management ...

Diabetes mellitus type 2 and prediabetes are diet-related diseases with varied individual responses to routine dietary interventions.

The efficacy of dietary interventions for prediabetes ...

Prebiotic supplementation significantly reduced body fat (SMD: −1.271, 95 % CI: −2.326 to −0.216). Fructose replacement significantly reduced postprandial ...

Effectiveness of an Incentives-Enhanced Stepped Care ...

After 3 years, 34.8% of participants in the intervention arm developed diabetes compared with 47.3% in the control arm (adjusted risk difference ...

4.

digitalcommons.fiu.edu

digitalcommons.fiu.edu/record/12941

Effectiveness of a 6-month Nutrition Intervention Targeting ...

Participants with high compliance with treatment, were more able to achieve better fruit and vegetable intake, fiber intake, nutrition knowledge and self- ...

Early effective intervention can significantly reduce all ...

The results revealed that early effective intervention significantly reduced all-cause mortality by 18% in prediabetic patients without a ...

Outcome of lifestyle intervention in relation to duration ...

We observed that ~43% of lifestyle intervention participants reverted to NGR, whereas 50% had persistent pre-diabetes, consistent with ~30% to ~ ...

Different Effects of Lifestyle Intervention in High- and Low-Risk ...

We tested whether individuals with prediabetes with low risk (LR) benefit from conventional LI and individuals with high risk (HR) benefit from ...

Early effective intervention can significantly reduce all-cause ...

The results indicate that effective intervention can significantly reduce all-cause mortality in prediabetic patients without a history of cardiovascular ...

Prediabetes remission and cardiovascular morbidity ...

Prediabetes is associated with increased risk of cardiovascular disease and heart failure. Multicomponent lifestyle interventions, including ...