Status:
RECRUITING
PILI 'Āina Household
Lead Sponsor:
University of Hawaii
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Type 2 Diabetes
Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 Pr...
Eligibility Criteria
Inclusion
- Age 18+ (looking for older adults)
- Native Hawaiian resident in a participating homestead
- Overweight or obese (BMI ≥ 25 kg/m\^2)
- Prior diagnosis of T2D 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
- No children
- Pregnancy
- Serious illness such as cancer or chronic pain that may contraindicate full participation
Key Trial Info
Start Date :
February 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 10 2028
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT06526273
Start Date
February 12 2025
End Date
January 10 2028
Last Update
June 3 2025
Active Locations (2)
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1
Kula no nā Po'e Hawai'i
Honolulu, Hawaii, United States, 96813
2
Kapolei Community Development Corporation
Kapolei, Hawaii, United States, 96707