PILI 'Āina Intervention for Cardiometabolic Health

This study is testing an intervention called PILI 'Āina, which uses a raised-bed home garden to help households increase vegetable intake and learn culturally relevant health practices. It aims to improve the management of conditions like Type 2 Diabetes, high blood pressure (hypertension), and high cholesterol (dyslipidemias), and to reduce risk factors for diet-related illnesses. The study is looking for Native Hawaiian adults who are overweight or obese and have at least one of these conditions. Success will be measured by changes in household food patterns, food insecurity, and the nutrition environment over 12 months. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 168 participants. It will compare the PILI 'Āina intervention to a Diabetes Prevention Program Lifestyle Intervention.
What's involved
Participants will receive a 3-month educational program, followed by a 6-month intervention. Data collection will occur at baseline, 3, 9, and 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months, with data collection at 3, 9, and 12 months after the start of the study.

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NCT06590649

Household Participants

Not Yet Recruiting
NAAges 18+Interventional
University of Hawaii
~168 participants
Updated 2024-09-19 on ClinicalTrials.gov
What's tested:Household-level effects

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Household Food Patterns
Measured over Month 3, Month 9, Month 12
+3 more outcomes measured
Type 2 Diabetes
Hypertension
Dyslipidemias
Overweight and Obesity
2 sites across 1 states
Hawaii2

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Eligibility criteria

Inclusion

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

  • Food insecurityMonth 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.

  • Nutrition EnvironmentMonth 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.

  • Physical ActivityMonth 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.