PILI 'Āina Household
NCT Number: NCT06526273
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type 2 Diabetes|Hypertension|Dyslipidemias|Overweight and Obesity
Interventions: BEHAVIORAL: PILI 'Āina|OTHER: Control
Sponsor: University of Hawaii
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 210
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-11
Locations: Kula no nā Po'e Hawai'i, Honolulu, Hawaii, 96813, United States|Kapolei Community Development Corporation, Kapolei, Hawaii, 96707, United States

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.

Primary Outcome Measures: Diet Quality, To measure diet quality, research staff will collect participants' 24-hour dietary recall by using the Modified 3-Pass Method. They will record diet information, and analysis will be performed by the Pacific Tracker (PacTrac) Program, 4th edition, developed at the University of Hawaii Cancer Center to analyze diets common in Hawai'i. It generates a "healthy eating index" (from 0 = least healthy to 100 = healthiest) shown to have good validity and reliability. Continuous values of the overall score will constitute our primary outcome, but the investigators will also evaluate scores for subscales (diet adequacy, moderation). The investigators will also assess diet quality and patterns by comparing servings consumed for each food group (vegetables, fruits, grains, dairy, and protein) to the United States Department of Agriculture (USDA) dietary guidelines., Baseline, 3 month, 9 month, 12 month|Weight, The investigators will measure weight (with clothing but without shoes) to the nearest 0.1 kilograms on an electric digital scale (Tanita model BSB800AS, Tokyo, Japan). Scales will be calibrated monthly., Baseline, 3 month, 9 month, 12 month|Waist and Hip circumference, Waist and hip circumference will be measured twice with a cloth tape measure, each time to the nearest 0.1 cm, and the average will be used for analysis., Baseline, 3 month, 9 month, 12 month|Height, The investigators will use a portable stadiometer (SECA Road Rod) to record the average of 2 measurements of height to the nearest 0.1 cm. Scales will be calibrated monthly., Baseline, 3 month, 9 month, 12 month|Blood pressure, Blood pressure will be collected with a mercury sphygmomanometer or with a portable automatic blood pressure device (Omron©HEM-907XL, Omron Healthcare) previously used with Native Hawaiians (NHs) to capture changes in blood pressure over time reliably. For both methods, study staff will be trained and certified with standard protocols that involve taking 3 measurements and using the last 2 to obtain each participant's average systolic and diastolic blood pressure (mm Hg). Systolic and diastolic blood pressure will be measured as continuous mm Hg and binary hypertension indicators (≥ 130 systolic or ≥ 80 mm Hg diastolic)., Baseline, 3 month, 9 month, 12 month|hemoglobin A1c, Hemoglobin A1c will be measured by DCA Vantage portable analyzers, using blood samples by fingerstick. Results are available in 5 minutes and will be returned to participants. A1c values will be recorded both as a continuous value (%) to the tenths digit and as a binary indicator of A1c \< 8%., Baseline, 3 month, 9 month, 12 month|Lipids, Lipids will be measured by Alere Cholestech LDX portable analyzers, using blood samples by fingerstick. Results are available in 5 minutes and will be returned to participants. Lipids (Low-Density Lipoproteins \[LDL\] and High-Density Lipoproteins \[HDL\]) will be measured as continuous mg/dL and as binary indicators of healthy cholesterol levels (LDL ≤ 130; HDL ≥ 40)., Baseline, 3 month, 9 month, 12 month
Secondary Outcome Measures: 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., Baseline, 3 month, 9 month, 12 month|Food literacy, Food literacy, defined as the ability to make healthy food choices in different settings and situations, will be assessed by the 11-item self-perceived food literacy scale, which encompasses knowledge, skills, and behaviors pertinent to planning, selecting, preparing, and eating healthy food. The responses and scores range from 1-not at all/never, 2-disagree, 3-slightly disagree, 4- slightly agree, 5-yes/always. Higher scores indicate greater food literacy., Baseline, 3 month, 9 month, 12 month|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., Baseline, 3 month, 9 month, 12 month|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., Baseline, 3 month, 9 month, 12 month|Social support, Social support for a healthy diet will be measured as the perceived support that people who make dietary changes receive from family and friends. An 11-item questionnaire on social support will be used to ask participants' perceived level of support from friends and family regarding diet choices. The responses and scores range from 1-strongly disagree, 2-somewhat disagree, 3-neutral, 4-somewhat agree, and 5-strongly agree. Higher scores indicate greater social support., Baseline, 3 month, 9 month, 12 month|Medications, Name and dosage for prescription medications for type 2 diabetes, hypertension, dyslipidemia, or cardiovascular disease will be recorded from containers brought to data collection visits., Baseline, 3 month, 9 month, 12 month|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., Baseline, 3 month, 9 month, 12 month|Diet self-efficacy, The 11-item Diet Self Efficacy Scale will measure self-efficacy in avoiding tempting high caloric food and managing social and internal cues and negative emotions. The responses and scores range from 1-strongly disagree, 2-somewhat disagree, 3-neutral, 4-somewhat agree, and 5-strongly agree. Higher scores indicate greater self-efficacy with diet., Baseline, 3 month, 9 month, 12 month
Other Outcome Measures: Demographic Data- Date of Birth, Date of birth:

* Month
* Day
* Year, Baseline|Demographic Data- Biological Sex, Biological Sex:

* Female
* Male, Baseline|Demographic Data- Marital status, Marital Status:

* Never married
* Currently married
* Divorced or separated
* Widow/widower
* Domestic partnership/other, Baseline|Demographic Data- Employment, Employment:

* Full time
* Part-time
* Unemployed
* Self-employed
* Retired
* Unable to work/other
* Household caretaker, Baseline|Demographic Data- Education, Education:

* Less than high school
* High school diploma/General Education Diploma (GED)
* Some college/technical training
* College degree
* Graduate/professional degree, Baseline|Demographic Data- Ethnic ancestry, Ethnic Ancestry:

* Caucasian
* Chinese
* Filipino
* Hawaiian
* Latino
* Japanese
* Korean
* Marshallese
* Micronesian (specify)
* Native American
* Portuguese
* Samoan
* Other (specify), Baseline|Demographic Data- Household income, 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., Baseline|Demographic Data- Household Composition, Household Composition:

1. Who lives in the participants 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, Baseline|Smoking/alcohol, Tobacco and alcohol use will be measured by using a measure developed by Dr. Kaholokula for PILI 'Ohana., Baseline, 3 month, 9 month, 12 month|Cultural identity, Cultural factors will be measured by the 4-item Cultural Identity Scale that will assess the degree of identification with NH cultural heritage. The responses and scores range from 0-not at all knowledgeable, 1- somewhat not knowledgeable, 2-neutral or no response, 3-somewhat knowledgeable, and 4-very knowledgeable. Higher scores indicate greater cultural identity., Baseline, 3 month, 9 month, 12 month|Neighborhood environment, 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., Baseline, 3 month, 9 month, 12 month|Comorbidities, 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., Baseline, 3 month, 9 month, 12 month