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Not yet recruiting NCT06590649

Household Participants

No phase Interventional Type 2 Diabetes Hypertension Dyslipidemias Overweight and Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Household-level effects.
Who it may be relevant to
Registry conditions: Type 2 Diabetes, Hypertension, Dyslipidemias, Overweight and Obesity. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

PILI 'Āina 2 Household Participants

Overview

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

  • Behavioral Household-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 materi

Primary outcome measures

  • Household Food Patterns [Time frame: Month 3, Month 9, Month 12]
  • Food insecurity [Time frame: Month 3, Month 9, Month 12]
  • Nutrition Environment [Time frame: Month 3, Month 9, Month 12]
  • Physical Activity [Time frame: Month 3, Month 9, Month 12]
Secondary outcome measures (11)
  • Demographic Data- Date of Birth [Time frame: Baseline]
  • Demographic Data- Biological Sex [Time frame: Baseline]
  • Demographic Data- Marital status [Time frame: Baseline]
  • Demographic Data- Employment [Time frame: Baseline]
  • Demographic Data- Education [Time frame: Baseline]
  • Demographic Data- Ethic Ancestry [Time frame: Baseline]
  • Demographic Data- Household income [Time frame: Baseline]
  • Demographic Data- Household Composition [Time frame: Baseline]
  • Smoking/alcohol [Time frame: Month 3, Month 9, Month 12]
  • Neighborhood environment [Time frame: Month 3, Month 9, Month 12]
  • Comorbidities [Time frame: Month 3, Month 9, Month 12]

Eligibility criteria

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

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 2 centers
  • Kula no nā Po'e Hawai'i — Honolulu
  • Kapolei Community Development Corporation — Kapolei

Identifiers

NCT: NCT06590649 · PILI 'Āina 2 Household Members · R01HL168858

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗