PILI 'Āina Program for Diet-Related Diseases

Recruiting at 1 trial location

Overseen By Claire Ing, DrPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Hawaii

Disqualifiers: Children, Pregnancy, Cancer, others

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

Compensation: Varies

Number of Visits: 9

210 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a traditional Native Hawaiian lifestyle can improve diet-related health issues, such as diabetes and high blood pressure. Participants will follow the PILI 'Āina program, which involves growing their own vegetables and learning traditional cooking methods. The trial will compare this approach with standard health education. It suits Native Hawaiians who are overweight, have conditions like diabetes, and are willing to engage in gardening and cooking activities. As an unphased trial, this study offers a unique opportunity to engage in culturally relevant health practices that may enhance well-being.

Do I need to stop my current medications for the 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 for improving diet-related health outcomes?

Research has shown that the PILI 'Āina program is generally safe for participants. This program, which focuses on culturally meaningful diets, has been well-received by the Hawaiian community. No specific reports of negative effects have emerged. By emphasizing traditional diets and lifestyle changes, such as growing and cooking fresh vegetables, the program aims to improve health without introducing new risks. Although specific data on side effects is lacking, positive feedback suggests it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PILI 'Āina treatment because it offers a fresh approach to tackling diet-related diseases. Unlike traditional treatments focused on medications or generic dietary advice, PILI 'Āina emphasizes a hands-on, culturally tailored lifestyle intervention. This program involves participants using a raised-bed home garden to grow their own vegetables, which not only increases access to fresh produce but also teaches culturally relevant cooking methods. Additionally, this method fosters family bonding through shared activities, potentially leading to more sustainable lifestyle changes. This holistic, community-centered approach could offer a more engaging and effective way to improve diet and health outcomes.

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

Research shows that the PILI 'Āina Program, available to participants in this trial, has positive health effects, especially for Native Hawaiian adults. Studies have found that similar traditional diet programs aid in weight loss and reducing blood pressure. Participants in past programs also experienced improvements in heart health. This suggests that the PILI 'Āina Program could enhance diet and lower the risk of heart diseases. The program includes activities such as growing vegetables at home, promoting healthier eating and strengthening family connections. ^{1 2 3 4 5}

Who Is on the Research Team?

Claire Ing, DrPH

Principal Investigator

University of Hawaii

Are You a Good Fit for This Trial?

This trial is for individuals with obesity, high blood pressure, dyslipidemia, or type 2 diabetes. It's specifically designed to help Native Hawaiians improve their health by managing these conditions and reducing the risk of developing new diet-related illnesses.

Inclusion Criteria

Native Hawaiian resident in a participating homestead

Capable of 150 minutes of moderate physical activity (e.g., brisk walking) per week

Fluent in written and spoken English

Exclusion Criteria

I have a serious illness that might stop me from fully participating.

I do not have any children.

Pregnancy

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 as part of the Diabetes Prevention Program's Lifestyle Intervention

12 weeks

Monthly visits (in-person or virtual)

PILI 'Āina Intervention

Participants engage in a 6-month intervention using a raised-bed home garden to increase vegetable intake and participate in cooking lessons and family bonding activities

24 weeks

Monthly visits (in-person or virtual)

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 against a control group. The program includes adapting traditional Hawaiian lifestyles and diets through community-wide cooking demonstrations to see if they can improve diet quality and cardiometabolic health.

How Is the Trial Designed?

Group I: PILI 'Āina Experimental Treatment 1 Intervention

Participants will receive the 3-month adapted Diabetes Prevention Program's Lifestyle Intervention. At 3 months, participants randomized to the PILI 'Āina intervention will receive a 6-month intervention centered around the use of a raised-bed home garden as the means of engaging household members to 1) increase their access to and intake of vegetables, 2) learn culturally relevant ways of preparing/cooking fresh vegetables through hands-on cooking lessons with local experts, and 3) build family cohesion through family bonding activities. The participating households will be given all the equipment and materials (e.g., soil, seeds, instructions, setup of equipment) needed to grow their vegetables using their raised-bed home garden box throughout the entire study. The investigators will provide seeds for the vegetables that can grow in a relatively short period (i.e., within 6 weeks). All lessons will be delivered by a trained community health worker .

Group II: Control Active Control 1 Intervention

Participants randomized to the control group will receive monthly untailored health education information and links to community resources from the community health worker via United States Postal Service or electronic messaging. Examples include information on food assistance programs, farmers markets, cultural events, and physical activity events.

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+

Published Research Related to This Trial

In a survey of 3,000 consumers, 17% reported experiencing adverse events from health food use, but only 11% of these cases were reported to public health centers, highlighting a significant gap in reporting.

Physicians and pharmacists often do not report adverse events due to health foods because they struggle to establish a clear cause-and-effect relationship, indicating a need for better education on the importance of reporting such incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behaviors in Response to Adverse Events Associated with Health Food Use: Internet Survey of Consumers, Physicians and Pharmacists. Chiba, T., Kobayashi, E., Sato, Y., et al.[2018]

Citations

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

The PILI 'Āina Project We have developed a multilevel intervention to promote healthy eating, weight loss, and cardiovascular health for overweight/obese Native Hawaiian adults ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4927448/

The PILI@Work Program: a translation of the diabetes ... This study examined the effectiveness of PILI@Work and factors associated with weight loss at post-intervention. Overweight/obese employees of ...

5. d-nb.info d-nb.info/1105069354/34

The PILI@Work Program: a translation of the diabetes ... The aims of this paper are to examine the effectiveness in translating the Diabetes Prevention Program in Native Hawaiian-serving worksites and to elucidate ...