PILI 'Āina Household

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Hawaii

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18+ (looking for older adults)

Native Hawaiian resident in a participating homestead

Overweight or obese (BMI ≥ 25 kg/m²)

Prior diagnosis of T2D or pre-diabetes, hypertension, and/or dyslipidemia (LDL cholesterol ≥ 130 mg/dL)

Disqualifiers

No children

Pregnancy

Serious illness such as cancer or chronic pain that may contraindicate full participation

Trial design

Design model

Parallel

Treatments tested in this trial

  • PILI 'Āina

    Behavioral

    Participants will receive the 3-month adapted Diabetes Prevention Program's Lifestyle Intervention. These lessons will be delivered by a trained community health worker. 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).

  • Control

    Other intervention

    Participants will receive the 3-month adapted Diabetes Prevention Program's Lifestyle Intervention. These lessons will be delivered by a trained community health worker based on previously tested materials and protocols. At 3 months, participants randomized to the control group will receive monthly untailored health education information and links to community resources from the community health worker via United States Postal Service or electronic messaging. Examples include information on food assistance programs, farmers' markets, cultural events, and physical activity events.

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: PILI 'ĀinaExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 3 month, 9 month, 12 month
2

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.

Time frame
Baseline, 3 month, 9 month, 12 month
3

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.

Time frame
Baseline, 3 month, 9 month, 12 month
4

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).

Time frame
Baseline, 3 month, 9 month, 12 month

Secondary outcomes

1

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.

Time frame
Baseline, 3 month, 9 month, 12 month
2

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.

Time frame
Baseline, 3 month, 9 month, 12 month
3

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.

Time frame
Baseline, 3 month, 9 month, 12 month
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.

Time frame
Baseline, 3 month, 9 month, 12 month

Other outcomes

1

Demographic Data- Date of Birth

Date of birth: * Month * Day * Year

Time frame
Baseline
2

Demographic Data- Biological Sex

Biological Sex: * Female * Male

Time frame
Baseline
3

Demographic Data- Marital status

Marital Status: * Never married * Currently married * Divorced or separated * Widow/widower * Domestic partnership/other

Time frame
Baseline
4

Demographic Data- Employment

Employment: * Full time * Part-time * Unemployed * Self-employed * Retired * Unable to work/other * Household caretaker

Time frame
Baseline

Sponsors and contacts

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University of Hawaii

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator