Diet Program for Diet-Related Diseases

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

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

Research on traditional Hawaiian diets, similar to PILI 'Āina, shows they can help reduce weight, lower cholesterol, and improve blood pressure. These diets are low in fat and high in complex carbohydrates, which have been effective in improving health markers in Native Hawaiians. ^{1 2 3 4 5}

Is the traditional Hawaiian diet safe for humans?

The traditional Hawaiian diet, used in programs like the Uli'eo Koa and Waianae Diet Program, has been shown to be safe for humans. Participants experienced weight loss and improvements in blood pressure and cholesterol without any reported safety issues. ^{1 2 3 4 6}

How does the PILI 'Āina treatment differ from other treatments for diet-related diseases?

The PILI 'Āina treatment is unique because it incorporates a culturally sensitive, community-based approach that emphasizes traditional Hawaiian dietary practices and cultural teachings. This approach not only focuses on dietary changes but also includes family and community support, making it distinct from standard calorie-restricted diets. ^{1 2 3 4 6}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

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

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

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

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

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

4. 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]

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

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

6. 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]