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

Trial Summary

What is the purpose of this trial?

Native Hawaiians' traditional lifestyles and diets ensured the mutual health and well-being of the land and its inhabitants, which stand in stark contrast to the disproportionately high prevalence of diet-related, cardiometabolic diseases they experience today. In this project, the investigators will adapt and test an evidence-based multilevel intervention entitled PILI 'Āina to improve the self-management of prevalent cardiometabolic diseases and reduce risk factors for developing new diet-related illnesses and implement and evaluate the impact and sustainability of community-wide cooking demonstrations. The objectives of this project are to optimize the effectiveness and sustainability of PILI 'Āina, improve diet quality, cardiometabolic markers, promote traditional Native Hawaiian diets, and improve social cohesion.

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 data supports the effectiveness of the PILI 'Āina treatment for diet-related diseases?

The PILI 'Āina treatment is similar to the Diabetes Prevention Program Lifestyle Intervention, which has shown significant improvements in weight, blood pressure, and diet among Native Hawaiians and Pacific Islanders. This suggests that culturally tailored, community-based programs can be effective in managing diet-related diseases. ^{1 2 3 4 5}

Is the PILI 'Āina Program safe for humans?

The PILI 'Āina Program, similar to other traditional Hawaiian diet programs, has shown positive health effects like weight loss and improved blood pressure without any reported safety issues. These programs focus on culturally appropriate diets and have been well-received in the Hawaiian community, suggesting they are generally safe for human use. ^{1 6 7 8 9}

How is the PILI 'Āina treatment different from other treatments for diet-related diseases?

The PILI 'Āina treatment is unique because it incorporates traditional Hawaiian dietary practices and cultural teachings, focusing on a community-based approach to address diet-related diseases. This treatment emphasizes cultural sensitivity, family support, and a whole-person approach, which are not typically found in standard treatments for these conditions. ^{1 6 7 9 10}

Research Team

Claire Ing, DrPH

Principal Investigator

University of Hawaii

Eligibility Criteria

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

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

Native Hawaiian resident in a participating homestead

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Waianae Diet Program: a culturally sensitive, community-based obesity and clinical intervention program for the Native Hawaiian population. [2004]

2. United States pubmed.ncbi.nlm.nih.gov

The Hawai'i Community Resource Obesity Project: results from the Lifestyle Enhancement Program. [2009]

3. England pubmed.ncbi.nlm.nih.gov

Adaptions to the National Diabetes Prevention Programme lifestyle change curriculum by Hawai'i Federally Qualified Health Centers: a qualitative descriptive study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Translating the Diabetes Prevention Program in Native Hawaiian and Pacific Islander communities: the PILI 'Ohana Project. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Formative Research to Inform Nutrition Interventions in Chuuk and the US Pacific. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Uli'eo Koa Program: incorporating a traditional Hawaiian dietary component. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

The PILI 'Ohana Project: a community-academic partnership to achieve metabolic health equity in Hawai'i. [2018]

8. Japan pubmed.ncbi.nlm.nih.gov

Behaviors in Response to Adverse Events Associated with Health Food Use: Internet Survey of Consumers, Physicians and Pharmacists. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Obesity and cardiovascular risk intervention through the ad libitum feeding of traditional Hawaiian diet. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

A family and community focused lifestyle program prevents weight regain in Pacific Islanders: a pilot randomized controlled trial. [2021]