- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06526650
'Ai Pono Cooking Demonstrations
The PILI 'Āina Project
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Claire Ing, DrPH
- Phone Number: 8086921042
- Email: clairemt@hawaii.edu
Study Contact Backup
- Name: Ki'i Aweau
Study Locations
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96813
- Recruiting
- Kula no na Poe Hawaii
-
Contact:
- Meghan Kenney
- Phone Number: 8085208997
- Email: meghan@kula-papakolea.org
-
Kapolei, Hawaii, United States, 96707
- Recruiting
- Kapolei Community Development Coalition
-
Contact:
- Chantal Keliihoomalu
- Email: executivedirector@kapoleiheritage.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18+ (looking for older adults)
- Native Hawaiian resident in a participating homestead
- Overweight or obese (BMI ≥ 25 kg/m^2)
- Prior diagnosis of type 2 diabetes or pre-diabetes, hypertension, and/or dyslipidemia (LDL cholesterol ≥ 130 mg/dL)
- Capable of 150 minutes of moderate physical activity (e.g., brisk walking) per week
- Willing and able to participate in all aspects of the individual and household-level intervention
- Fluent in written and spoken English
Exclusion Criteria:
- No children
- Pregnancy
- Serious illness such as cancer or chronic pain that may contraindicate full participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Aim 3: Community Level Intervention
Aim 3 is community-driven, supports the overall goal of the PILI 'Āina project, allows all members of the community to benefit, and is strongly promoted within the community.
The investigators will design and implement 'Ai Pono, a community-level component that can operate in tandem with PILI 'Āina.
This component will not be tested in the group-randomized trial.
Instead, all 7 communities will implement 'Ai Pono for the full study period.
|
"Hands-on Cooking and Cultural Lessons" These lessons will be widely advertised.
Each 2-hour presentation will involve hands-on cooking demonstrations and tastings, accompanied by lessons on the cultural significance of featured food items.
Demonstrations will link the consumption of vegetables (e.g., sweet potato, breadfruit, kalo) to Native Hawaiian (NH) history and traditional beliefs to help participants rediscover their heritage through the meals they prepare.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nutrition Environment
Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year
|
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, 1-year, 2-year, 3-year, 4-year
|
|
Family Environment
Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year
|
Three subscales, Cohesion, Expressiveness, and Conflict, assess the degree of commitment and support family members provide for one another, the extent to which family members are encouraged to express their feelings directly, and the amount of openly expressed anger and conflict among family members.
|
Baseline, 1-year, 2-year, 3-year, 4-year
|
|
Social Cohesionn
Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year
|
4-item subscale of the neighborhood level stressors which asks about perceived shared values and trust.
|
Baseline, 1-year, 2-year, 3-year, 4-year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diet Self-Efficacy
Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year
|
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, 1-year, 2-year, 3-year, 4-year
|
|
Food Literacy
Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year
|
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, 1-year, 2-year, 3-year, 4-year
|
|
Social Support
Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year
|
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, 1-year, 2-year, 3-year, 4-year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cultural Identity
Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year
|
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, 1-year, 2-year, 3-year, 4-year
|
|
Demographic Data- Date of Birth
Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year
|
Date of birth:
|
Baseline, 1-year, 2-year, 3-year, 4-year
|
|
Demographic Data- Biological Sex
Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year
|
Biological Sex:
|
Baseline, 1-year, 2-year, 3-year, 4-year
|
|
Demographic Data- Marital status
Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year
|
Marital Status:
|
Baseline, 1-year, 2-year, 3-year, 4-year
|
|
Demographic Data- Employment
Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year
|
Employment:
|
Baseline, 1-year, 2-year, 3-year, 4-year
|
|
Demographic Data- Education
Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year
|
Education:
|
Baseline, 1-year, 2-year, 3-year, 4-year
|
|
Demographic Data- Ethnic ancestry
Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year
|
Ethnic Ancestry:
|
Baseline, 1-year, 2-year, 3-year, 4-year
|
|
Demographic Data- Household income
Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year
|
Household Income:
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, 1-year, 2-year, 3-year, 4-year
|
|
Demographic Data- Household Composition
Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year
|
Household Composition: 1. Who lives in the participant's house full-time? (50% or more time spent in-house)
|
Baseline, 1-year, 2-year, 3-year, 4-year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Claire Ing, DrPH, Principal Investigator
- Study Chair: Kulani DeSimone, B.S., Graduate Assistant
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Nutrition Disorders
- Metabolic Diseases
- Overnutrition
- Body Weight
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Lipid Metabolism Disorders
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Overweight
- Obesity
- Hypertension
- Diabetes Mellitus, Type 2
- Dyslipidemias
Other Study ID Numbers
- PILI 'Āina 3
- R01HL168858 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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