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临床试验/NCT03774277
NCT03774277已完成不适用

Chickasaw Healthy Eating Environments Research Study

Oklahoma State University Center for Health Sciences1 个研究点 分布在 1 个国家目标入组 262 人开始时间: 2018年7月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
262
试验地点
1
主要终点
Change in systolic blood pressure

研究概览

简要总结

This study, the Chickasaw Healthy Eating Environments Research Study (CHEERS), will be conducted in partnership with Chickasaw Nation. CHEERS comprises several mutually reinforcing strategies to improve blood pressure (BP) control in people with hypertension. Environmental strategies include the investigator's innovative "Packed Promise for a Healthy Heart" program that provides hypertensive adults ages 18 and older with a voucher for fresh vegetables and fruits (referred to as a "fresh check") and home delivered food boxes that contain Dietary Approaches to Stop Hypertension (DASH)-approved ingredients for preparing low-salt, and traditional healthy Chickasaw meals. The study facilitates demonstrations of healthy cooking practices in participating communities. At the individual level, tribal members with uncontrolled hypertension will receive heart-healthy recipes (available at getfreshcooking.com) that are tailored to traditional Chickasaw diet and culture, educational materials, along with invitations to attend cooking demonstrations, fresh checks to improve access to fresh produce, and a Chickasaw Nation culturally-informed smartphone walking app called "AYA." At the policy level, CHEERS will culminate in a multimedia documentary presentation for tribal leadership detailing the intervention and featuring personal success stories by hypertensive community members. Study findings, including a health economics assessment, will be used to encourage policies for further expansion of the Packed Promise for a Healthy Heart Program; and policies promoting expansion of brick and mortar grocery outlets in rural Chickasaw communities.

详细描述

This study is guided by the principles of community-based participatory research (CBPR).

Aims and Methods: Co-led by an AI (Choctaw) Investigator, the study will:

Aim #1: Evaluate CHEERS' ability to improve healthy food access by collecting quantitative data on changes in perceived ability to purchase and prepare healthy food, and by using qualitative methods to evaluate the reach, saturation, and acceptability of the CHEERS intervention.

Aim #2: Measure the intervention's effect on change in BP and secondary outcomes among hypertensive community members with poorly controlled hypertension.

Aim #3: Disseminate a multimedia documentary of the study's findings and evaluate the documentary's effect on tribal leaders across the Chickasaw Nation and other tribal communities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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
否

入选标准

  • •≥18 years old
  • •Self-identify as American Indian/Alaska Native
  • •Currently reside in the four communities and do not plan on moving for 12 months
  • •Not currently pregnant, or ≥ 6 weeks postpartum
  • •Ability to understand written and spoken English
  • •Ability and willingness to follow study protocols
  • •Self-reported previous diagnosis of hypertension by a medical professional and a measured systolic BP ≥ 130 mm Hg at time of enrollment or no previous hypertension diagnosis and a measured systolic BP ≥ 130 mm Hg at both the initial screening and prior to finalizing enrollment (i.e. on two separate days)

排除标准

  • •- Anyone not meeting the aforementioned inclusion criteria

研究组 & 干预措施

Intervention Communities

Experimental

Packed Promise for a Healthy Heart intervention, free Tribal Wellness Center membership, a Fitbit, and the AYA culturally based mobile walking app.

干预措施: Packed Promise for a Healthy Heart (Behavioral)

Control Communities

No Intervention

Free Tribal Wellness Center membership, Fitbit, and the AYA culturally based mobile walking app

结局指标

主要结局

Change in systolic blood pressure

时间窗: Measured before and after the 6 month intervention

Targeted 2.9 mm Hg decrease in systolic blood pressure

次要结局

  • Diet(Measured before and after the 6 month intervention)
  • Change in body mass index(Measured before and after the 6 month intervention)
  • Food security(Measured before and after the 6 month intervention)

研究者

发起方
Oklahoma State University Center for Health Sciences
申办方类型
Other
责任方
Sponsor

研究点 (1)

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