Recruiting

Observational Study

Sponsor:

University of Hawaii

Code:

NCT06526273

Conditions

Type 2 Diabetes

Hypertension

Dyslipidemias

Overweight and Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PILI 'Āina

Control

Study Details

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

Study ID

NCT06526273

Start date

Feb 12, 2025

Status verified date

Apr, 2025

Completion date

Feb 26, 2029

Anticipated

Primary completion date

Feb 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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 .

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.

Interventions

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).

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.

Primary outcome measure

  • Diet Quality [ Time Frame: Baseline, 3 month, 9 month, 12 month ]
  • Weight [ Time Frame: Baseline, 3 month, 9 month, 12 month ]
  • Height [ Time Frame: Baseline, 3 month, 9 month, 12 month ]
  • Blood pressure [ Time Frame: Baseline, 3 month, 9 month, 12 month ]
  • hemoglobin A1c [ Time Frame: Baseline, 3 month, 9 month, 12 month ]
  • Lipids [ Time Frame: Baseline, 3 month, 9 month, 12 month ]

Central Contacts and Locations

Locations

Kula no nā Po'e Hawai'i

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

Kapolei Community Development Corporation

Recruiting

Kapolei, Hawaii, United States, 96707

Contacts

More Information

Sponsor

University of Hawaii

Last update posted

Mar 4, 2026

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Hawaii on 2026-03-04.