Household Participants

University of Hawaii

Status: Not yet enrolling

Conditions: Hypertension; Dyslipidemias; Overweight and Obesity; Type 2 Diabetes

Treatments: Behavioral: Household-level effects

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06590649

R01HL168858 (U.S. NIH Grant/Contract)

PILI 'Āina 2 Household Members

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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168 participants in 1 patient group

Household Participants

Experimental group

Description:

The 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.

Treatment:

Behavioral: Household-level effects