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Идёт набор NCT06526273

PILI 'Āina Household

Без фазы С лечением Type 2 Diabetes Hypertension Dyslipidemias Overweight and Obesity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: PILI 'Āina, Control.
Кому может быть актуально
Состояния в реестре: Type 2 Diabetes, Hypertension, Dyslipidemias, Overweight and Obesity. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

The PILI 'Āina Project

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое PILI 'Āina
    Participants will receive the 3-month adapted Diabetes Prevention Program's Lifestyle Intervention. These lessons will be delivered by a trained community health worker. 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 th
  • Другое Control
    Participants will receive the 3-month adapted Diabetes Prevention Program's Lifestyle Intervention. These lessons will be delivered by a trained community health worker based on previously tested materials and protocols. At 3 months, participants randomized to the control group will receive monthly untailored health education information and links to community resources from the community health worker via United States Postal Service or electronic messaging. Examples include information on food

Первичные конечные точки

  • Diet Quality [Срок оценки: Baseline, 3 month, 9 month, 12 month]
  • Weight [Срок оценки: Baseline, 3 month, 9 month, 12 month]
  • Height [Срок оценки: Baseline, 3 month, 9 month, 12 month]
  • Blood pressure [Срок оценки: Baseline, 3 month, 9 month, 12 month]
  • hemoglobin A1c [Срок оценки: Baseline, 3 month, 9 month, 12 month]
  • Lipids [Срок оценки: Baseline, 3 month, 9 month, 12 month]
Вторичные конечные точки (8)
  • Food Insecurity [Срок оценки: Baseline, 3 month, 9 month, 12 month]
  • Food literacy [Срок оценки: Baseline, 3 month, 9 month, 12 month]
  • Nutrition Environment [Срок оценки: Baseline, 3 month, 9 month, 12 month]
  • Household food patterns [Срок оценки: Baseline, 3 month, 9 month, 12 month]
  • Social support [Срок оценки: Baseline, 3 month, 9 month, 12 month]
  • Medications [Срок оценки: Baseline, 3 month, 9 month, 12 month]
  • Physical Activity [Срок оценки: Baseline, 3 month, 9 month, 12 month]
  • Diet self-efficacy [Срок оценки: Baseline, 3 month, 9 month, 12 month]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • No children
  • Pregnancy
  • Serious illness such as cancer or chronic pain that may contraindicate full participation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • Kula no nā Po'e Hawai'i — Honolulu
  • Kapolei Community Development Corporation — Kapolei

Идентификаторы

NCT: NCT06526273 · PILI 'Āina 2 · R01HL168858

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗