PILI 'Āina Household

NCT06526273 | Recruiting DMC

• 2 other identifiers: PILI 'Āina 2R01HL168858
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Type 2 Diabetes; Hypertension; Dyslipidemias; Overweight and Obesity

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (8)

• Food Insecurity

  Baseline, 3 month, 9 month, 12 month

• Food literacy

  Baseline, 3 month, 9 month, 12 month

• Nutrition Environment

  Baseline, 3 month, 9 month, 12 month

• Household food patterns

  Baseline, 3 month, 9 month, 12 month

• Social support

  Baseline, 3 month, 9 month, 12 month

Other Outcomes (12)

• Demographic Data- Date of Birth

  Baseline

• Demographic Data- Biological Sex

  Baseline

• Demographic Data- Marital status

  Baseline

Study Arms (2)

PILI 'Āina

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

PILI 'Āina BEHAVIORAL

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).

PILI 'Āina

Control OTHER

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Hawaii: lead

Study Sites (2)

Kula no nā Po'e Hawai'i

Honolulu, Hawaii, 96813, United States

RECRUITING

Kapolei Community Development Corporation

Kapolei, Hawaii, 96707, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Dyslipidemias; Overweight; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Claire Ing, DrPH

  University of Hawaii

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire Ing, DrPH

CONTACT

808-692-1042; clairemt@hawaii.edu

Ki'i Aweau

CONTACT

808-220-2110‬; kkaweau@hawaii.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: July 29, 2024
• Study Start: February 12, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 26, 2029
• Last Updated: March 4, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)