Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06590649

Household Participants

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kula no nā Po'e Hawai'i, Honolulu, Hawaii, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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.

Other names: PILI 'Aina 2

Primary outcomes

  1. Household Food Patterns

    Time frame: Month 3, Month 9, Month 12

    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.

  2. Food insecurity

    Time frame: Month 3, Month 9, Month 12

    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.

  3. Nutrition Environment

    Time frame: Month 3, Month 9, Month 12

    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.

  4. Physical Activity

    Time frame: Month 3, Month 9, Month 12

    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.

Secondary outcomes

  1. Demographic Data- Date of Birth

    Time frame: Baseline

    Date of birth:

    • Month
    • Day
    • Year
  2. Demographic Data- Biological Sex

    Time frame: Baseline

    Biological Sex:

    • Female
    • Male
  3. Demographic Data- Marital status

    Time frame: Baseline

    Marital Status:

    • Never married
    • Currently married
    • Divorced or separated
    • Widow/widower
    • Domestic partnership/other
  4. Demographic Data- Employment

    Time frame: Baseline

    Employment:

    • Full time
    • Part-time
    • Unemployed
    • Self-employed
    • Retired
    • Unable to work/other
    • Household caretaker
  5. Demographic Data- Education

    Time frame: Baseline

    Education:

    • Less than high school
    • High school diploma/General Education Diploma (GED)
    • Some college/technical training
    • College degree
    • Graduate/professional degree
  6. Demographic Data- Ethic Ancestry

    Time frame: Baseline

    Ethnic Ancestry:

    • Caucasian
    • Chinese
    • Filipino
    • Hawaiian
    • Latino
    • Japanese
    • Korean
    • Marshallese
    • Micronesian (specify)
    • Native American
    • Portuguese
    • Samoan
    • Other (specify)
  7. Demographic Data- Household income

    Time frame: Baseline

    Household Income:

    • Under $49,999
    • $50,000-$74,999
    • $75,000-$99,999
    • $100,000-$124,999
    • Over $125,000

    Household income will be classified according to the US Census Bureau's poverty threshold by using a dichotomous variable. Participation in public assistance programs (e.g., Temporary Assistance for Needy Families, Supplemental Nutrition Assistance Program) will also be recorded.

  8. Demographic Data- Household Composition

    Time frame: Baseline

    Household Composition:

    • Who lives in your house full-time? (50% or more time spent in-house)
    • Parents
    • Children
    • Grandparents/great-grandparents
    • Other family members

    a. Of those people, what are their ages and genders?

    • Male: 17 years and under, 18-29 yrs, 30-39 yrs, 40-39 yrs, 50-59 yrs, 60+ yrs
    • Female: 17 years and under, 18-29 yrs, 30-39 yrs, 40-39 yrs, 50-59 yrs, 60+ yrs
    • Number of other/non-binary: 17 years and under, 18-29 yrs, 30-39 yrs, 40-39 yrs, 50-59 yrs, 60+ yrs
  9. Smoking/alcohol

    Time frame: Month 3, Month 9, Month 12

    Tobacco and alcohol use will be measured by using a measure developed by Dr. Kaholokula for PILI 'Ohana.

  10. Neighborhood environment

    Time frame: Month 3, Month 9, Month 12

    Neighborhood environment will be measured by the 17-item modified Neighborhood Level Stressors Scale, which assesses participants' perceptions of 4 neighborhood dimensions (i.e., walkability, availability of healthy food, safety, and social cohesion). The responses and scores range from 1-strongly disagree, 2-somewhat disagree, 3- neutral, 4-somewhat agree, 5-strongly agree. Higher scores indicate low neighborhood level stressors.

  11. Comorbidities

    Time frame: Month 3, Month 9, Month 12

    Existing comorbidities will be measured as whether the participant has ever been told by a healthcare professional that they have had a heart attack, heart failure, stroke, or chronic kidney disease.

Study contacts

Contact information is provided by the study sponsor or research team.

Claire Ing, DrPH

CONTACT

[email protected]

8086921042

Ki'i Aweau

CONTACT

[email protected]

8082202110

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

PILI 'Āina 2 Household Participants

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.