Household Participants

NCT06590649 | Not Yet Recruiting DMC

• 2 other identifiers: PILI 'Āina 2 Household MembersR01HL168858
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 2 Diabetes; Hypertension; Dyslipidemias; Overweight and Obesity

Outcome Measures

Primary Outcomes (4)

• Household Food Patterns

  Household food patterns will be measured by 4 questions that assess the frequency of meal planning, eating meals with household members, bringing prepared restaurant foods home, and preparing meals with household members. The responses and scores range from 1- 1 day, 2- 2-3 days, 3- 4-5 days, 4- 6 days, 5- 7 days. Higher scores indicate greater household food patterns.

  Month 3, Month 9, Month 12

• Food insecurity

  Food insecurity will be measured by the 10-item Household Food Security Survey Module, which captures the qualitative and quantitative dimensions of household food supply, including psychological and behavioral responses of household members, and generates a binary indicator of food insecurity at the household level. The responses and scores range from 1-often true, 2-sometimes true, 3-never true. Higher scores indicate low food insecurity.

  Month 3, Month 9, Month 12

• Nutrition Environment

  The perceived 9-item nutrition environment will be measured by the Gustafson Perceived Nutrition Environment Measures questionnaire, which examines perceived access and availability of healthy foods within \~1 mile of the participant's home, and the availability and affordability of produce in the participant's primary food store. The responses and scores vary depending on the question including 0- disagree, 1-agree, and 0-not important, 1-slightly important, 2-moderately important, 3- important, 4-very important. Higher scores indicate higher perceived access and availability of food.

  Month 3, Month 9, Month 12

• Physical Activity

  The 3-item Physical Activity Questionnaire, which has been used with Native Hawaiians, will assess exercise frequency during the past month. It contains 3 items that assess moderate and vigorous exercise and changes in activity levels. The responses and scores vary depending on the question, including 0- rarely or never, 1- 2-3 times over the month, 2- about once a week, 3- 2-4 times a week, 4- more than 4 times a week. Higher scores indicate greater physical activity.

  Month 3, Month 9, Month 12

Secondary Outcomes (11)

• Demographic Data- Date of Birth

  Baseline

• Demographic Data- Biological Sex

  Baseline

• Demographic Data- Marital status

  Baseline

• Demographic Data- Employment

  Baseline

• Demographic Data- Education

  Baseline

Study Arms (1)

Household Participants

EXPERIMENTAL

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.

Behavioral: Household-level effects

Interventions

Household-level effects 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.

Also known as: PILI 'Aina 2

Household Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Hawaii: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Kula no nā Po'e Hawai'i

Honolulu, Hawaii, 96813, United States

Location

Kapolei Community Development Corporation

Kapolei, Hawaii, 96707, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Dyslipidemias; Overweight; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Claire Ing, DrPH

CONTACT

8086921042; clairemt@hawaii.edu

Ki'i Aweau

CONTACT

8082202110; kkaweau@hawaii.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)