Household Participants
Part of paid clinical trials in Honolulu, Hawaii.
- Sponsor
- University of Hawaii
- Study ID
- NCT06590649
- Status
- Not Yet Recruiting
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Conditions
- Dyslipidemias
- Hypertension
- Overweight and Obesity
- Type 2 Diabetes
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Household-level effects — BEHAVIORALAt 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). The household participants will be analyzed side by side with the index participants.
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
- Oct 31, 2024
- Status verified
- Sep 2024
- Primary completion
- Nov 30, 2027
- Completion
- Nov 30, 2027
Study Design
- Enrollment
- 168 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Experimental: Household ParticipantsThe household participants will be analyzed alongside the index participants to determine household-level effects from the intervention. Household participants must live in an index participant's household. Index participants are allowed to have up to 3 household participants.
Primary Outcome Measure
Household Food Patterns [ Time Frame: Month 3, Month 9, Month 12 ]
Central Contacts
- Claire Ing, DrPH8086921042
- Ki'i Aweau8082202110
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 | - |
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