PILI 'Āina Household

The PILI 'Āina Project

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Dyslipidemias; Type 2 Diabetes; Overweight and Obesity
• Intervention / Treatment: Behavioral: PILI 'Āina; Other: Control

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claire Ing, DrPH; Phone Number: 808-692-1042; Email: clairemt@hawaii.edu
• Study Contact Backup: Name: Ki'i Aweau; Phone Number: 808-220-2110‬; Email: kkaweau@hawaii.edu

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Recruiting
      • Kula no nā Po'e Hawai'i
      • Contact: Adrienne Y Dillard, PhD; Phone Number: (808) 520-8997; Email: kula.papakolea@gmail.com
    • Kapolei, Hawaii, United States, 96707
      • Recruiting
      • Kapolei Community Development Corporation
      • Contact: Chantal Keli'iho'omalu; Phone Number: (808) 628-4626; Email: info@kapoleiheritage.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PILI 'Āina; 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 .	Behavioral: PILI 'Āina; Participants will receive the 3-month adapted Diabetes Prevention Program's Lifestyle Intervention. These lessons will be delivered by a trained community health worker. 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. Participants 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. They will receive seeds for the vegetables that can grow in a relatively short period (i.e., within 6 weeks).
Active Comparator: Control; 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.	Other: Control; Participants will receive the 3-month adapted Diabetes Prevention Program's Lifestyle Intervention. These lessons will be delivered by a trained community health worker based on previously tested materials and protocols. At 3 months, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diet Quality	To measure diet quality, research staff will collect participants' 24-hour dietary recall by using the Modified 3-Pass Method. They will record diet information, and analysis will be performed by the Pacific Tracker (PacTrac) Program, 4th edition, developed at the University of Hawaii Cancer Center to analyze diets common in Hawai'i. It generates a "healthy eating index" (from 0 = least healthy to 100 = healthiest) shown to have good validity and reliability. Continuous values of the overall score will constitute our primary outcome, but the investigators will also evaluate scores for subscales (diet adequacy, moderation). The investigators will also assess diet quality and patterns by comparing servings consumed for each food group (vegetables, fruits, grains, dairy, and protein) to the United States Department of Agriculture (USDA) dietary guidelines.	Baseline, 3 month, 9 month, 12 month
Weight	The investigators will measure weight (with clothing but without shoes) to the nearest 0.1 kilograms on an electric digital scale (Tanita model BSB800AS, Tokyo, Japan). Scales will be calibrated monthly.	Baseline, 3 month, 9 month, 12 month
Height	The investigators will use a portable stadiometer (SECA Road Rod) to record the average of 2 measurements of height to the nearest 0.1 cm. Scales will be calibrated monthly.	Baseline, 3 month, 9 month, 12 month
Blood pressure	Blood pressure will be collected with a mercury sphygmomanometer or with a portable automatic blood pressure device (Omron©HEM-907XL, Omron Healthcare) previously used with Native Hawaiians (NHs) to capture changes in blood pressure over time reliably. For both methods, study staff will be trained and certified with standard protocols that involve taking 3 measurements and using the last 2 to obtain each participant's average systolic and diastolic blood pressure (mm Hg). Systolic and diastolic blood pressure will be measured as continuous mm Hg and binary hypertension indicators (≥ 130 systolic or ≥ 80 mm Hg diastolic).	Baseline, 3 month, 9 month, 12 month
hemoglobin A1c	Hemoglobin A1c will be measured by DCA Vantage portable analyzers, using blood samples by fingerstick. Results are available in 5 minutes and will be returned to participants. A1c values will be recorded both as a continuous value (%) to the tenths digit and as a binary indicator of A1c < 8%.	Baseline, 3 month, 9 month, 12 month
Lipids	Lipids will be measured by Alere Cholestech LDX portable analyzers, using blood samples by fingerstick. Results are available in 5 minutes and will be returned to participants. Lipids (Low-Density Lipoproteins [LDL] and High-Density Lipoproteins [HDL]) will be measured as continuous mg/dL and as binary indicators of healthy cholesterol levels (LDL ≤ 130; HDL ≥ 40).	Baseline, 3 month, 9 month, 12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food Insecurity	Food insecurity will be measured by the 10-item Household Food Security Survey Module, which captures the qualitative and quantitative dimensions of household food supply, including psychological and behavioral responses of household members, and generates a binary indicator of food insecurity at the household level. The responses and scores range from 1-often true, 2-sometimes true, 3-never true. Higher scores indicate low food insecurity.	Baseline, 3 month, 9 month, 12 month
Food literacy	Food literacy, defined as the ability to make healthy food choices in different settings and situations, will be assessed by the 11-item self-perceived food literacy scale, which encompasses knowledge, skills, and behaviors pertinent to planning, selecting, preparing, and eating healthy food. The responses and scores range from 1-not at all/never, 2-disagree, 3-slightly disagree, 4- slightly agree, 5-yes/always. Higher scores indicate greater food literacy.	Baseline, 3 month, 9 month, 12 month
Nutrition Environment	The perceived 9-item nutrition environment will be measured by the Gustafson Perceived Nutrition Environment Measures questionnaire, which examines perceived access and availability of healthy foods within ~1 mile of the participant's home, and the availability and affordability of produce in the participant's primary food store. The responses and scores vary depending on the question including 0- disagree, 1-agree, and 0-not important, 1-slightly important, 2-moderately important, 3- important, 4-very important. Higher scores indicate higher perceived access and availability of food.	Baseline, 3 month, 9 month, 12 month
Household food patterns	Household food patterns will be measured by 4 questions that assess the frequency of meal planning, eating meals with household members, bringing prepared restaurant foods home, and preparing meals with household members. The responses and scores range from 1- 1 day, 2- 2-3 days, 3- 4-5 days, 4- 6 days, 5- 7 days. Higher scores indicate greater household food patterns.	Baseline, 3 month, 9 month, 12 month
Social support	Social support for a healthy diet will be measured as the perceived support that people who make dietary changes receive from family and friends. An 11-item questionnaire on social support will be used to ask participants' perceived level of support from friends and family regarding diet choices. The responses and scores range from 1-strongly disagree, 2-somewhat disagree, 3-neutral, 4-somewhat agree, and 5-strongly agree. Higher scores indicate greater social support.	Baseline, 3 month, 9 month, 12 month
Medications	Name and dosage for prescription medications for type 2 diabetes, hypertension, dyslipidemia, or cardiovascular disease will be recorded from containers brought to data collection visits.	Baseline, 3 month, 9 month, 12 month
Physical Activity	The 3-item Physical Activity Questionnaire, which has been used with Native Hawaiians, will assess exercise frequency during the past month. It contains 3 items that assess moderate and vigorous exercise and changes in activity levels. The responses and scores vary depending on the question, including 0- rarely or never, 1- 2-3 times over the month, 2- about once a week, 3- 2-4 times a week, 4- more than 4 times a week. Higher scores indicate greater physical activity.	Baseline, 3 month, 9 month, 12 month
Diet self-efficacy	The 11-item Diet Self Efficacy Scale will measure self-efficacy in avoiding tempting high caloric food and managing social and internal cues and negative emotions. The responses and scores range from 1-strongly disagree, 2-somewhat disagree, 3-neutral, 4-somewhat agree, and 5-strongly agree. Higher scores indicate greater self-efficacy with diet.	Baseline, 3 month, 9 month, 12 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic Data- Date of Birth	Date of birth: Month; Day; Year	Baseline
Demographic Data- Biological Sex	Biological Sex: Female; Male	Baseline
Demographic Data- Marital status	Marital Status: Never married; Currently married; Divorced or separated; Widow/widower; Domestic partnership/other	Baseline
Demographic Data- Employment	Employment: Full time; Part-time; Unemployed; Self-employed; Retired; Unable to work/other; Household caretaker	Baseline
Demographic Data- Education	Education: Less than high school; High school diploma/General Education Diploma (GED); Some college/technical training; College degree; Graduate/professional degree	Baseline
Demographic Data- Ethnic ancestry	Ethnic Ancestry: Caucasian; Chinese; Filipino; Hawaiian; Latino; Japanese; Korean; Marshallese; Micronesian (specify); Native American; Portuguese; Samoan; Other (specify)	Baseline
Demographic Data- Household income	Household Income: Under $49,999; $50,000-$74,999; $75,000-$99,999; $100,000-$124,999; Over $125,000 Household income will be classified according to the US Census Bureau's poverty threshold by using a dichotomous variable. Participation in public assistance programs (e.g., Temporary Assistance for Needy Families, Supplemental Nutrition Assistance Program) will also be recorded.	Baseline
Demographic Data- Household Composition	Household Composition: 1. Who lives in the participants house full-time? (50% or more time spent in-house); Parents; Children; Grandparents/great-grandparents; Other family membersa. Of those people, what are their ages and genders?; Male: 17 years and under, 18-29 yrs, 30-39 yrs, 40-39 yrs, 50-59 yrs, 60+ yrs; Female: 17 years and under, 18-29 yrs, 30-39 yrs, 40-39 yrs, 50-59 yrs, 60+ yrs; Number of other/non-binary: 17 years and under, 18-29 yrs, 30-39 yrs, 40-39 yrs, 50-59 yrs, 60+ yrs	Baseline
Smoking/alcohol	Tobacco and alcohol use will be measured by using a measure developed by Dr. Kaholokula for PILI 'Ohana.	Baseline, 3 month, 9 month, 12 month
Cultural identity	Cultural factors will be measured by the 4-item Cultural Identity Scale that will assess the degree of identification with NH cultural heritage. The responses and scores range from 0-not at all knowledgeable, 1- somewhat not knowledgeable, 2-neutral or no response, 3-somewhat knowledgeable, and 4-very knowledgeable. Higher scores indicate greater cultural identity.	Baseline, 3 month, 9 month, 12 month
Neighborhood environment	Neighborhood environment will be measured by the 17-item modified Neighborhood Level Stressors Scale, which assesses participants' perceptions of 4 neighborhood dimensions (i.e., walkability, availability of healthy food, safety, and social cohesion). The responses and scores range from 1-strongly disagree, 2-somewhat disagree, 3- neutral, 4-somewhat agree, 5-strongly agree. Higher scores indicate low neighborhood level stressors.	Baseline, 3 month, 9 month, 12 month
Comorbidities	Existing comorbidities will be measured as whether the participant has ever been told by a healthcare professional that they have had a heart attack, heart failure, stroke, or chronic kidney disease.	Baseline, 3 month, 9 month, 12 month

Collaborators and Investigators

• Sponsor: University of Hawaii
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Claire Ing, DrPH, University of Hawaii

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 26, 2029

Study Registration Dates

• First Submitted: June 7, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Lipid Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Hypertension; Diabetes Mellitus, Type 2; Dyslipidemias
• Other Study ID Numbers: PILI 'Āina 2; R01HL168858 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No