Household Participants

NCT ID: NCT06590649

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2027-11-30

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.

Conditions

Type 2 Diabetes; Hypertension; Dyslipidemias; Overweight and Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Household Participants

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.

Group Type: EXPERIMENTAL

Household-level effects

Intervention Type: BEHAVIORAL

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 through hands-on cooking lessons with local experts, and 3) build family cohesion through family bonding activities. Participants will be given all the equipment and materials (e.g., soil, seeds, instructions, setup of equipment) needed to grow their vegetables using their raised-bed home garden box throughout the entire study. They will receive seeds for the vegetables that can grow in a relatively short period (i.e., within 6 weeks). The household participants will be analyzed side by side with the index participants.

Interventions

Household-level effects

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 through hands-on cooking lessons with local experts, and 3) build family cohesion through family bonding activities. Participants will be given all the equipment and materials (e.g., soil, seeds, instructions, setup of equipment) needed to grow their vegetables using their raised-bed home garden box throughout the entire study. They will receive seeds for the vegetables that can grow in a relatively short period (i.e., within 6 weeks). The household participants will be analyzed side by side with the index participants.

Intervention Type: BEHAVIORAL

Other Intervention Names

PILI 'Aina 2

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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Hawaii

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kula no nā Po'e Hawai'i

Honolulu, Hawaii, United States

Kapolei Community Development Corporation

Kapolei, Hawaii, United States

Countries

United States

Central Contacts

Claire Ing, DrPH

Role: CONTACT

clairemt@hawaii.edu

8086921042

Ki'i Aweau

Role: CONTACT

kkaweau@hawaii.edu

8082202110

Other Identifiers

R01HL168858

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PILI 'Āina 2 Household Members

Identifier Type: -

Identifier Source: org_study_id