PILI 'Āina Household

University of Hawaii

Status: Enrolling

Conditions: Hypertension; Dyslipidemias; Overweight and Obesity; Type 2 Diabetes

Treatments: Other: Control; Behavioral: PILI 'Āina

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06526273

PILI 'Āina 2

R01HL168858 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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 household levels compared to a Diabetes Prevention Program Lifestyle Intervention only group. The investigators will enroll 180 Native Hawaiian adults with overweight or obesity and at least 1 other diet-related cardiometabolic condition (Type 2 diabetes, pre-diabetes, hypertension, pre-hypertension, dyslipidemia). These index participants will receive the 3-month educational program and then be randomized at the household level to the 6-month PILI Aina intervention or to a control group. Data collection will occur at baseline and 3, 9, and 12 months. Other adult household members will be invited to participate in data collection at the same time to evaluate household-level effects.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18+ (looking for older adults)
• Native Hawaiian resident in a participating homestead
• Overweight or obese (BMI ≥ 25 kg/m^2)
• Prior diagnosis of T2D or pre-diabetes, hypertension, and/or dyslipidemia (LDL cholesterol ≥ 130 mg/dL)
• Capable of 150 minutes of moderate physical activity (e.g., brisk walking) per week
• Willing and able to participate in all aspects of the individual and household-level intervention
• Fluent in written and spoken English

Exclusion criteria

• No children
• Pregnancy
• Serious illness such as cancer or chronic pain that may contraindicate full participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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210 participants in 2 patient groups

PILI 'Āina

Experimental group

Description:

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 .

Treatment:

Behavioral: PILI 'Āina

Control

Active Comparator group

Description:

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.

Treatment:

Other: Control