PILI 'Āina Household Study for Cardiometabolic Health
This study, called PILI 'Āina Household, is testing an adapted lifestyle program to help Native Hawaiian adults manage or reduce their risk of conditions like Type 2 Diabetes, high blood pressure (hypertension), and high cholesterol (dyslipidemia). You might be able to join if you are an adult Native Hawaiian resident in a participating homestead, are overweight or obese, and have a diagnosis of Type 2 Diabetes, pre-diabetes, hypertension, and/or dyslipidemia. The study is comparing two approaches: the PILI 'Āina intervention, which includes a 3-month adapted Diabetes Prevention Program followed by a 6-month intervention, versus a control group that only receives the 3-month adapted Diabetes Prevention Program. Researchers will look at changes in diet quality and weight to see if the interventions are successful. The current recruitment status is unclear.
- Study design
- This study is a group-randomized controlled trial planning to enroll 210 participants. Participants will be assigned to one of two groups to compare the effectiveness of the interventions.
- What's involved
- You would participate in a 3-month educational program. Depending on your group, you might then receive a 6-month intervention. Data will be collected at the start, and at 3, 9, and 12 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months after the start of the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
PILI 'Āina Household
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Claire Ing, DrPH · PRINCIPAL_INVESTIGATOR · University of Hawaii
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Diet QualityBaseline, 3 month, 9 month, 12 month
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.
- WeightBaseline, 3 month, 9 month, 12 month
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.
- HeightBaseline, 3 month, 9 month, 12 month
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.
- Blood pressureBaseline, 3 month, 9 month, 12 month
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).
- hemoglobin A1cBaseline, 3 month, 9 month, 12 month
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%.
- LipidsBaseline, 3 month, 9 month, 12 month
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).