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临床试验/NCT06077162
NCT06077162进行中(未招募)不适用

Diabetes Nutrition Education (What Can I Eat? [WCIE]) and Healthy Food Resource for American Indians and Alaska Natives With T2D

Colorado State University2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
67
试验地点
2
主要终点
Hemoglobin A1c

研究概览

简要总结

Healthy nutrition habits are key to managing type 2 diabetes (T2D). However, American Indian and Alaska Natives (AI/ANs) often lack access to culturally relevant nutrition education and they disproportionately experience food insecurity. Food insecurity, defined as lack of consistent access to enough food for an active, healthy life, negatively impacts one's ability to engage in diabetes self-management and care. The purpose of this study is to evaluate if diabetes nutrition education and an added food security resource, such as farmers market vouchers for fruits and vegetables, can improve diabetes self-management for AI/ANs with T2D. Researchers will work with collaborators at the Oklahoma City Indian Clinic in Oklahoma City, OK, and an American Indian community advisory board (CAB) throughout the study to ensure the nutrition education and food security resources are designed to meet the needs of the community and clinic. With the guidance of the CAB, researchers will recruit adults with T2D to participate in a 3-month intervention. Participants will be randomized into one of 3 groups. Some people will have diabetes nutrition education and the food security resource, some will have only the diabetes nutrition education, and some will receive only the food security resource. Outcomes such as food security status and clinical diabetes health indicators will be measured at 5 timepoints. This intervention is significant to diabetes because AI/ANs experience diabetes health disparities and the combination of diabetes nutrition education plus an added food security resource could help decrease T2D complications and improve quality of life for AI/ANs.

详细描述

Background: Healthy nutrition is key to T2D self-care and management. Culturally relevant nutrition education for American Indian and Alaska Natives (AI/Ans) is limited, contributing to diabetes health disparities, and disproportionate rates of food insecurity exacerbates these disparities.

Hypothesis: AI/ANs with T2D who receive both culturally relevant diabetes nutrition education and food security resources will have more improved outcomes (e.g., dietary intake, HbA1c) than AI/ANs with T2D who receive only diabetes nutrition education or a food security resource.

Supporting Rationale: Nutrition education improves T2D outcomes and reducing food insecurity can decrease diabetes health disparities.

Specific Aims: Aim #1: Engage an AI/AN community advisory board to support rigorous and equitable community based participatory research; Aim #2: Implement and evaluate a diabetes nutrition education and food security resource intervention in collaboration with the Oklahoma City Indian Clinic in Oklahoma City, OK.

Research Design: Three arm randomized controlled trial with: intervention group (diabetes nutrition education + food security resource); diabetes nutrition education group only; food security resource group only. Three month intervention with diabetes nutrition education and food security resource with 5 data collection timepoints: baseline, 1, 3, 6, 9 months. Outcomes include: HbA1c, blood pressure, dietary intake, diabetes distress, and food security.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • Dx type 2 diabetes; American Indian or Alaska Native; fluent in English

排除标准

  • Planned move within the study period

结局指标

主要结局

Hemoglobin A1c

时间窗: 0, 3, 6, 9 months

Participant HbA1c will be collected by point of care fingerstick or electronic medical record

次要结局

  • Diabetes distress(0, 3, 6, 9 months)
  • Blood pressure(0, 3, 6, 9 months)
  • Food insecurity(0, 3, 6, 9 months)
  • Economic Quality of Life(0, 3, 6, 9 months)
  • What Can I Eat? Impact Survey(0, 3, 6, 9 months)
  • Dietary intake - 24 hour recall(0, 3 months (2 * 24 hour recalls at each timepoint = 4 * 24 hour recalls per participant))
  • Body weight(0, 3, 6, 9 months)
  • Perceived Diabetes Self Management Scale (PDSMS)(0, 3, 6, 9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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