跳至主要内容
临床试验/NCT06526650
NCT06526650招募中不适用

The PILI 'Āina Project

University of Hawaii2 个研究点 分布在 1 个国家目标入组 1,780 人开始时间: 2025年2月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,780
试验地点
2
主要终点
Social Cohesionn

研究概览

简要总结

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.

详细描述

In Years 1 - 5, the investigators will hold quarterly cooking demonstrations and cultural lessons for a total of 36 events. The lessons will be aimed at improving family and community eating environments of participants and social cohesion of these communities. Attendance at each lesson will be limited to 30 individuals. Attendees will register via REDCap using their names and email addresses. There is no limit to how many lessons an individual can attend, but after the first lesson the investigators reserve 15 of the 30 spots for people who have not attended previously, as identified by their registration information. At each quarterly event, the investigators survey participants to assess their reaction to the lesson, their vegetable and fruit intake, self-efficacy for healthy diet, and perceptions of community cohesion. Surveys will take ~5-10 minutes to complete. Additionally, the investigators will survey random samples of homestead households (n = 20 per homestead, total n = 140 per year) in Projects Years 1 - 5. Total sample for this activity is 700. Each sample will be selected independent of previous samples, and it is possible the same households will be sampled multiple times.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Aim 3: Community Level Intervention

Other

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.

干预措施: 'Ai Pono (Other)

结局指标

主要结局

Social Cohesionn

时间窗: 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.

Family Environment

时间窗: 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.

Nutrition Environment

时间窗: 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.

次要结局

  • Social Support(Baseline, 1-year, 2-year, 3-year, 4-year)
  • Diet Self-Efficacy(Baseline, 1-year, 2-year, 3-year, 4-year)
  • Food Literacy(Baseline, 1-year, 2-year, 3-year, 4-year)

研究者

发起方
University of Hawaii
申办方类型
Other
责任方
Sponsor

研究点 (2)

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