Behavioural Intervention

PILI 'Āina Program for Diet-Related Diseases

Kapolei, HI

N/A

Waitlist Available

Led By Claire Ing, DrPH

Research Sponsored by University of Hawaii

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Overweight or obese (BMI ≥ 25 kg/m^2)

Be older than 18 years old

Must not have

No children

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 month, 9 month, 12 month

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to improve the health of Native Hawaiians by using a program called PILI 'Āina to help manage diet-related diseases. The program includes community cooking demonstrations and focuses on improving diet

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves dietary changes and lifestyle adaptations rather than medication, side effects are not typical as in drug trials but may include adjustments in digestion or energy levels due to dietary changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is 25 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any children.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 month, 9 month, 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 month, 9 month, 12 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 month, 9 month, 12 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood pressure

Diet Quality

Height

+4 more

Secondary study objectives

Diet self-efficacy

Food Insecurity

Food literacy

+5 more

Other study objectives

Comorbidities

Cultural identity

Demographic Data- Biological Sex

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PILI 'ĀinaExperimental Treatment1 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: ControlActive Control1 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.

0 / 2Eligibility criteria met