PILI 'Āina Household
Part of paid clinical trials in Honolulu, Hawaii.
- Sponsor
- University of Hawaii
- Study ID
- NCT06526273
- Status
- Recruiting
Conditions
- Dyslipidemias
- Hypertension
- Overweight and Obesity
- Type 2 Diabetes
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- PILI 'Āina — BEHAVIORALParticipants 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 — OTHERParticipants 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.
Study Details
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.
Key Dates
- Start date
- Feb 12, 2025
- Status verified
- Apr 2025
- Primary completion
- Feb 1, 2029
- Completion
- Feb 26, 2029
Study Design
- Enrollment
- 210 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: PILI 'ĀinaParticipants 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: ControlParticipants 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 ]
Central Contacts
- Claire Ing, DrPH808-692-1042
- Ki'i Aweau808-220-2110
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Kula no nā Po'e Hawai'i | Honolulu | Hawaii | 96813 | |
| Kapolei Community Development Corporation | Kapolei | Hawaii | 96707 |
Find similar trials in Honolulu, HI
Related Studies
- Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)Recruiting · Duke University · Phoenix, Arizona
- 'Ai Pono Cooking DemonstrationsRecruiting · University of Hawaii · Honolulu, Hawaii
- Household ParticipantsNot Yet Recruiting · University of Hawaii · Honolulu, Hawaii
- EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular DiseasePHASE3 · Recruiting · Boehringer Ingelheim · Anniston, Alabama