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Household Participants

ConditionsType 2 DiabetesHypertensionDyslipidemiasOverweight and Obesity
Trial statusNot yet recruiting
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 accepts healthy volunteers

Qualifiers

Current resident of the household in which an index participant lives

Willing to complete data collection protocols

Fluent in written and spoken English

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

168 Participants
are divided into 1 treatment group
Group A: Household ParticipantsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
Month 3, Month 9, Month 12
2

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
Month 3, Month 9, Month 12
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
Month 3, Month 9, Month 12
4

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.

Time frame
Month 3, Month 9, Month 12

Secondary 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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Hawaii

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: