Clinical trial NCT06526650: 'Ai Pono Cooking Demonstrations
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 Institutes of Health (NIH)
name: American Heart Association
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-07-30
Enrollment: 1780
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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: In Years 1 - 5, the investigators will hold quarterly cooking demonstrations and cultural lessons for a total of 36 events. The lessons will be aimed at improving family and community eating environments of participants and social cohesion of these communities. Attendance at each lesson will be limited to 30 individuals. Attendees will register via REDCap using their names and email addresses. There is no limit to how many lessons an individual can attend, but after the first lesson the investigators reserve 15 of the 30 spots for people who have not attended previously, as identified by their registration information. At each quarterly event, the investigators survey participants to assess their reaction to the lesson, their vegetable and fruit intake, self-efficacy for healthy diet, and perceptions of community cohesion. Surveys will take \~5-10 minutes to complete. Additionally, the investigators will survey random samples of homestead households (n = 20 per homestead, total n = 140 per year) in Projects Years 1 - 5. Total sample for this activity is 700. Each sample will be selected independent of previous samples, and it is possible the same households will be sampled multiple times.

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 type 2 diabetes 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: Family Environment
timeFrame: Baseline, 1-year, 2-year, 3-year, 4-year
measure: Nutrition Environment
timeFrame: Baseline, 1-year, 2-year, 3-year, 4-year
measure: Social Cohesionn
timeFrame: Baseline, 1-year, 2-year, 3-year, 4-year
Secondary outcomes:
measure: Diet Self-Efficacy
timeFrame: Baseline, 1-year, 2-year, 3-year, 4-year
measure: Food Literacy
timeFrame: Baseline, 1-year, 2-year, 3-year, 4-year
measure: Social Support
timeFrame: Baseline, 1-year, 2-year, 3-year, 4-year
Other outcomes:
measure: Cultural Identity
timeFrame: Baseline, 1-year, 2-year, 3-year, 4-year
measure: Demographic Data- Date of Birth
timeFrame: Baseline, 1-year, 2-year, 3-year, 4-year
measure: Demographic Data- Biological Sex
timeFrame: Baseline, 1-year, 2-year, 3-year, 4-year
measure: Demographic Data- Marital status
timeFrame: Baseline, 1-year, 2-year, 3-year, 4-year
measure: Demographic Data- Employment
timeFrame: Baseline, 1-year, 2-year, 3-year, 4-year
measure: Demographic Data- Education
timeFrame: Baseline, 1-year, 2-year, 3-year, 4-year
measure: Demographic Data- Ethnic ancestry
timeFrame: Baseline, 1-year, 2-year, 3-year, 4-year
measure: Demographic Data- Household income
timeFrame: Baseline, 1-year, 2-year, 3-year, 4-year
measure: Demographic Data- Household Composition
timeFrame: Baseline, 1-year, 2-year, 3-year, 4-year
Locations:
city: Honolulu
country: United States
facility: Kula no na Poe Hawaii
state: Hawaii
city: Kapolei
country: United States
facility: Kapolei Community Development Coalition
state: Hawaii
Study officials:
affiliation: Principal Investigator
name: Claire Ing, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Graduate Assistant
name: Kulani DeSimone, B.S.
role: STUDY_CHAIR
References: