Diet Program for Diet-Related Diseases

Not yet recruiting at 1 trial location

Overseen By Ki'i Aweau

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Hawaii

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a traditional Native Hawaiian diet, known as PILI 'Āina, can help manage and reduce the risk of cardiometabolic diseases, which relate to the heart and metabolism and often link to food habits. Researchers aim to determine if this diet can improve health markers and foster community connections through cooking demonstrations. The study focuses on households, so living with a participant and sharing experiences might make someone a good fit. This trial seeks to understand how adopting these traditional dietary practices can impact overall health and community well-being. As an unphased trial, it offers a unique opportunity to contribute to valuable research on traditional diets and community health.

Do I need to stop my current medications for this trial?

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 the PILI 'Āina program is safe?

Research has shown that the PILI 'Āina program is generally safe. This program encourages healthy eating and aims to improve diets, particularly within the Native Hawaiian community. Similar programs have been well-received, indicating safety and good tolerance.

The study is labeled as "Not Applicable" in phase, suggesting no major safety concerns. It emphasizes lifestyle and dietary changes rather than introducing a new drug or surgery, so the risks are likely low. Participants have provided positive feedback, and no significant negative effects have been reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PILI 'Āina diet program because it takes a unique approach by focusing on household-level impacts, not just individual changes. This program emphasizes community and familial support, which can lead to more sustainable lifestyle changes compared to traditional diet plans that often target individuals in isolation. By involving household members, the program aims to create a supportive environment that can amplify the benefits and make healthy eating habits more attainable and long-lasting for everyone involved.

What evidence suggests that the PILI 'Āina program is effective for improving diet-related cardiometabolic diseases?

Research has shown that the PILI 'Āina program, based on a traditional Hawaiian diet, can improve health. Studies have found that it aids in weight loss and better blood pressure control. In similar programs like PILI@Work, participants lost an average of 1.2 kg and improved their eating habits, including reduced fat intake and increased confidence in making healthy food choices. The program's success largely stems from its emphasis on traditional diets and community support. This evidence suggests that PILI 'Āina, which participants in this trial will follow, could help manage and lower the risk of diet-related diseases. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for Native Hawaiians dealing with obesity, dyslipidemia, type 2 diabetes, or high blood pressure. It aims to improve health through traditional diets and lifestyle changes. Specific eligibility criteria are not provided but typically would include factors like age range and specific health conditions.

Inclusion Criteria

Current resident of the household in which an index participant lives

Willing to complete data collection protocols

Fluent in written and spoken English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Educational Program

Participants receive a 3-month educational program focused on diet and health improvement

12 weeks

Monthly visits (in-person or virtual)

Intervention

Participants are randomized to the 6-month PILI Aina intervention or a control group

24 weeks

Visits at 3, 9, and 12 months for data collection

Follow-up

Participants are monitored for safety and effectiveness after the intervention

3 months

Visits at 9 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• PILI 'Āina

Trial Overview The PILI 'Āina program is being tested to see if it can help manage cardiometabolic diseases by promoting traditional Hawaiian diets and lifestyles. The study includes community-wide cooking demonstrations to evaluate the impact on diet quality and social cohesion.

How Is the Trial Designed?

Group I: Household Participants Experimental Treatment 1 Intervention

The household participants will be analyzed alongside the index participants to determine household-level effects from the intervention. Household participants must live in an index participant's household. Index participants are allowed to have up to 3 household participants.

Who Is Running the Clinical Trial?

University of Hawaii

Lead Sponsor

Trials

122

Recruited

55,200+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. reporter.nih.gov reporter.nih.gov/search/8_lIArRxkEGGmVgoIgCv-w/project-details/11082496

The PILI 'Āina Project In this project, we will adapt and test an evidence-based multilevel intervention entitled PILI 'Āina to improve the self-management of prevalent ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06526273

Study Details | NCT06526273 | PILI 'Āina Household The investigators will conduct a group-randomized controlled trial to test the effectiveness of PILI Aina for improving diet and health at the individual and ...

3. withpower.com withpower.com/trial/phase-overweight-7-2024-c945d

PILI 'Āina Program for Diet-Related Diseases The PILI 'Āina Program, similar to other traditional Hawaiian diet programs, has shown positive health effects like weight loss and improved blood pressure ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06526650

NCT06526650 | 'Ai Pono Cooking Demonstrations The objectives of this project are to optimize the effectiveness and sustainability of PILI 'Āina, improve diet quality, cardiometabolic markers, promote ...

5. link.springer.com link.springer.com/article/10.1007/s13142-015-0383-3

a translation of the diabetes prevention program to Native ... Overall, PILI@Work participants lost an average of 1.2 kg, which coincided with significant improvements in fat intake and eating self-efficacy.

6. ctv.veeva.com ctv.veeva.com/study/pili-aina-household

PILI 'Āina Household - ClinicalTrials.Veeva The objectives of this project are to optimize the effectiveness and sustainability of PILI 'Āina, improve diet quality, cardiometabolic markers ...

7. hhsp.hawaii.gov hhsp.hawaii.gov/assets/pdf/HHSP_PAN_Plan_WEB.pdf

Hawai'i Physical Activity and Nutrition Plan 2030 Recent data shows that only 20% of adults and only 14% of high schoolers ate five fruits and vegetables a day.5,6. Insufficient physical activity combined with ...