210 Participants Needed

PILI 'Āina Program for Diet-Related Diseases

Recruiting at 1 trial location
KA
CI
Overseen ByClaire Ing, DrPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Hawaii
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?

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.

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.12345

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.12356

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.178910

Who Is on the Research Team?

CI

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

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
See 3 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: PILI 'ĀinaExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

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.
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

The Waianae Diet Program: a culturally sensitive, community-based obesity and clinical intervention program for the Native Hawaiian population. [2004]
The Hawai'i Community Resource Obesity Project: results from the Lifestyle Enhancement Program. [2009]
Adaptions to the National Diabetes Prevention Programme lifestyle change curriculum by Hawai'i Federally Qualified Health Centers: a qualitative descriptive study. [2021]
Translating the Diabetes Prevention Program in Native Hawaiian and Pacific Islander communities: the PILI 'Ohana Project. [2023]
Formative Research to Inform Nutrition Interventions in Chuuk and the US Pacific. [2022]
Uli'eo Koa Program: incorporating a traditional Hawaiian dietary component. [2021]
The PILI 'Ohana Project: a community-academic partnership to achieve metabolic health equity in Hawai'i. [2018]
Behaviors in Response to Adverse Events Associated with Health Food Use: Internet Survey of Consumers, Physicians and Pharmacists. [2018]
Obesity and cardiovascular risk intervention through the ad libitum feeding of traditional Hawaiian diet. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
A family and community focused lifestyle program prevents weight regain in Pacific Islanders: a pilot randomized controlled trial. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security