Clinical trial NCT06526273: PILI 'Āina Household
Official title: The PILI 'Āina Project
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Hypertension
Dyslipidemias
Overweight and Obesity
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-07-29
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Diet Quality
timeFrame: Baseline, 3 month, 9 month, 12 month
measure: Weight
timeFrame: Baseline, 3 month, 9 month, 12 month
measure: Height
timeFrame: Baseline, 3 month, 9 month, 12 month
measure: Blood pressure
timeFrame: Baseline, 3 month, 9 month, 12 month
measure: hemoglobin A1c
timeFrame: Baseline, 3 month, 9 month, 12 month
measure: Lipids
timeFrame: Baseline, 3 month, 9 month, 12 month
Secondary outcomes:
measure: Food Insecurity
timeFrame: Baseline, 3 month, 9 month, 12 month
measure: Food literacy
timeFrame: Baseline, 3 month, 9 month, 12 month
measure: Nutrition Environment
timeFrame: Baseline, 3 month, 9 month, 12 month
measure: Household food patterns
timeFrame: Baseline, 3 month, 9 month, 12 month
measure: Social support
timeFrame: Baseline, 3 month, 9 month, 12 month
measure: Medications
timeFrame: Baseline, 3 month, 9 month, 12 month
measure: Physical Activity
timeFrame: Baseline, 3 month, 9 month, 12 month
measure: Diet self-efficacy
timeFrame: Baseline, 3 month, 9 month, 12 month
Other outcomes:
measure: Demographic Data- Date of Birth
timeFrame: Baseline
measure: Demographic Data- Biological Sex
timeFrame: Baseline
measure: Demographic Data- Marital status
timeFrame: Baseline
measure: Demographic Data- Employment
timeFrame: Baseline
measure: Demographic Data- Education
timeFrame: Baseline
measure: Demographic Data- Ethnic ancestry
timeFrame: Baseline
measure: Demographic Data- Household income
timeFrame: Baseline
measure: Demographic Data- Household Composition
timeFrame: Baseline
measure: Smoking/alcohol
timeFrame: Baseline, 3 month, 9 month, 12 month
measure: Cultural identity
timeFrame: Baseline, 3 month, 9 month, 12 month
measure: Neighborhood environment
timeFrame: Baseline, 3 month, 9 month, 12 month
measure: Comorbidities
timeFrame: Baseline, 3 month, 9 month, 12 month
Locations:
city: Honolulu
country: United States
facility: Kula no nā Po'e Hawai'i
state: Hawaii
city: Kapolei
country: United States
facility: Kapolei Community Development Corporation
state: Hawaii
Study officials:
affiliation: University of Hawaii
name: Claire Ing, DrPH
role: PRINCIPAL_INVESTIGATOR
References: