Dyslipidemias, Hypertension, Overweight and Obesity, Type 2 Diabetes
Conditions
Brief 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.
Detailed description
The investigators will conduct a group-randomized controlled trial to test the effectiveness of PILI Aina for improving diet and health at the individual and household levels compared to a Diabetes Prevention Program Lifestyle Intervention only group. The investigators will enroll 180 Native Hawaiian adults with overweight or obesity and at least 1 other diet-related cardiometabolic condition (Type 2 diabetes, pre-diabetes, hypertension, pre-hypertension, dyslipidemia). These index participants will receive the 3-month educational program and then be randomized at the household level to the 6-month PILI Aina intervention or to a control group. Data collection will occur at baseline and 3, 9, and 12 months. Other adult household members will be invited to participate in data collection at the same time to evaluate household-level effects.
Interventions
BEHAVIORALHousehold-level effects
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Hawaii
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Current resident of the household in which an index participant lives * Willing to complete data collection protocols * Fluent in written and spoken English
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Household Food Patterns | Month 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 insecurity | Month 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 Environment | Month 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 Activity | Month 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Demographic Data- Education | Baseline | Education: * Less than high school * High school diploma/General Education Diploma (GED) * Some college/technical training * College degree * Graduate/professional degree |
| Demographic Data- Ethic Ancestry | Baseline | Ethnic Ancestry: * Caucasian * Chinese * Filipino * Hawaiian * Latino * Japanese * Korean * Marshallese * Micronesian (specify) * Native American * Portuguese * Samoan * Other (specify) |
| Demographic Data- Household income | Baseline | 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. |
| Demographic Data- Date of Birth | Baseline | Date of birth: * Month * Day * Year |
| Smoking/alcohol | Month 3, Month 9, Month 12 | Tobacco and alcohol use will be measured by using a measure developed by Dr. Kaholokula for PILI 'Ohana. |
| Neighborhood environment | Month 3, Month 9, Month 12 | 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. |
| Comorbidities | Month 3, Month 9, Month 12 | 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. |
| Demographic Data- Household Composition | Baseline | Household Composition: 1\. Who lives in your 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 |
| Demographic Data- Biological Sex | Baseline | Biological Sex: * Female * Male |
| Demographic Data- Marital status | Baseline | Marital Status: * Never married * Currently married * Divorced or separated * Widow/widower * Domestic partnership/other |
| Demographic Data- Employment | Baseline | Employment: * Full time * Part-time * Unemployed * Self-employed * Retired * Unable to work/other * Household caretaker |
Countries
United States
Contacts
Primary ContactClaire Ing, DrPH
Backup ContactKi'i Aweau
Outcome results
None listed