Clinical trial NCT06590649: Household Participants
Official title: PILI 'Āina 2 Household Participants
Study type: INTERVENTIONAL
Overall status: NOT_YET_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: 2024-09-19
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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:

* Current resident of the household in which an index participant lives
* Willing to complete data collection protocols
* Fluent in written and spoken English

Exclusion Criteria:

-

Primary outcomes:
measure: Household Food Patterns
timeFrame: Month 3, Month 9, Month 12
measure: Food insecurity
timeFrame: Month 3, Month 9, Month 12
measure: Nutrition Environment
timeFrame: Month 3, Month 9, Month 12
measure: Physical Activity
timeFrame: Month 3, Month 9, Month 12
Secondary 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- Ethic Ancestry
timeFrame: Baseline
measure: Demographic Data- Household income
timeFrame: Baseline
measure: Demographic Data- Household Composition
timeFrame: Baseline
measure: Smoking/alcohol
timeFrame: Month 3, Month 9, Month 12
measure: Neighborhood environment
timeFrame: Month 3, Month 9, Month 12
measure: Comorbidities
timeFrame: Month 3, Month 9, Month 12
Other outcomes:
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:
References: