PILI 'Āina Household
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PILI 'Āina, Control.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes, Hypertension, Dyslipidemias, Overweight and Obesity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The PILI 'Āina Project
Overview
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.
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.
Interventions
- 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 th - 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
Primary outcome measures
- 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]
Secondary outcome measures (8)
- Food Insecurity [Time frame: Baseline, 3 month, 9 month, 12 month]
- Food literacy [Time frame: Baseline, 3 month, 9 month, 12 month]
- Nutrition Environment [Time frame: Baseline, 3 month, 9 month, 12 month]
- Household food patterns [Time frame: Baseline, 3 month, 9 month, 12 month]
- Social support [Time frame: Baseline, 3 month, 9 month, 12 month]
- Medications [Time frame: Baseline, 3 month, 9 month, 12 month]
- Physical Activity [Time frame: Baseline, 3 month, 9 month, 12 month]
- Diet self-efficacy [Time frame: Baseline, 3 month, 9 month, 12 month]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Kula no nā Po'e Hawai'i — Honolulu
- Kapolei Community Development Corporation — Kapolei
Identifiers
NCT: NCT06526273 · PILI 'Āina 2 · R01HL168858