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临床试验/NCT04831216
NCT04831216已完成不适用

Delivering Health: An Integrated Approach to Address Diabetes in the Context of Food Insecurity

University of Arkansas1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2021年8月24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
入组人数
101
试验地点
1
主要终点
Hemoglobin A1c (HbA1c), %

研究概览

简要总结

The goal of this study was to develop, implement, and evaluate the effectiveness of an intervention to use home-delivery of Type 2 diabetes (T2D)-appropriate food boxes with plain language adapted education materials to improve the nutritional health, physical activity, and health outcomes of low-income food insecure people with T2D in northwest Arkansas.

详细描述

Background and Rationale

Decades of increasing incidence of type 2 diabetes (T2D) present a multifaceted challenge to the health of a growing number of Americans, affecting their diets and how they live life. Approximately 30 million (~9%) of all people in the US have T2D, and this number is expected to continue to rise. At the same time, 15 million (11.8%) US households experience food insecurity, which is associated with risk for T2D and other chronic diseases. Both T2D and food insecurity are even more prevalent in Arkansas, with rates of T2D and food insecurity at 12.2% and 17.3%, respectively.

Approximately 46 million Americans per year turn to food pantries and related programs to help meet household nutritional needs. However, food pantries are not a long-term solution to improve health for food insecure people with T2D. Most food pantries do not provide food of sufficient dietary quality to support a healthy lifestyle.

Diabetes self-management education (DSME) is an approach with documented efficacy in helping people manage T2D. DSME supports informed decision-making, encourages goal setting and problem solving, and improves self-care behaviors. Recent studies have shown promise for DSME among food pantry clients with T2D. However, studies have suffered from problems with attendance and retention.

We designed a study to develop and evaluate the efficacy of a plain-language DSME curriculum to improve the nutritional health, physical activity, and health outcomes of low-income food insecure people with T2D. We home-delivered this curriculum along with T2D-appropriate healthy food boxes to mitigate difficulties associated with access to healthy food and attendance at DSME sessions outside of the home. We hypothesized that this approach will lead to improvements in participants' glycemic control, diet quality, and other outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

  • 18 years of age or older
  • Food insecure (confirmed with adapted 10-item screener)
  • HbA1c levels of ≥7%

排除标准

  • Conditions making it unlikely the participant will be able to follow the protocol, such as terminal illness, non-ambulatory, severe mental illness, severely impaired vision or hearing, eating disorder, or plans to move out of the geographic region
  • Only one adult per household will be enrolled

研究组 & 干预措施

Type 2 Diabetes Appropriate Food Boxes + Diabetes Education

Experimental

All participants will be assigned to a single intervention arm. The intervention includes weekly delivery of type 2 diabetes-appropriate food boxes that include diabetes self-management education materials.

干预措施: Type 2 Diabetes Appropriate Food Boxes + Diabetes Education (Behavioral)

结局指标

主要结局

Hemoglobin A1c (HbA1c), %

时间窗: Baseline; immediate post-intervention (approx. 20 weeks)

A Siemens analyzer was utilized to measure HbA1c (%) via finger stick blood collection.

次要结局

  • Type 2 Diabetes Self-Management Behaviors - Medication Adherence(Baseline; immediate post-intervention (approx. 20 weeks))
  • Diet Quality(Baseline; immediate post-intervention (approx. 20 weeks))
  • Diet Quality (2)(Baseline; immediate post-intervention (approx. 20 weeks))
  • Body Mass Index (BMI)(Baseline; immediate post-intervention (approx. 20 weeks))
  • Chronic Diseases(Baseline; immediate post-intervention (approx. 20 weeks))
  • Type 2 Diabetes Self-Management Self-Efficacy(Baseline; immediate post-intervention (approx. 20 weeks))
  • Oral Health(Baseline; immediate post-intervention (approx. 20 weeks))
  • Type 2 Diabetes-related Distress(Baseline; immediate post-intervention (approx. 20 weeks))
  • Food Security(Baseline)
  • Food Pantry Utilization(Baseline; immediate post-intervention (approx. 20 weeks))
  • Medication Adherence(Baseline; immediate post-intervention (approx. 20 weeks))
  • Cooking Skills and Knowledge (1)(Baseline)
  • Cooking Skills and Knowledge (2)(Baseline)
  • Type 2 Diabetes Self-Management Behaviors - General Diet(Baseline; immediate post-intervention (approx. 20 weeks))
  • Type 2 Diabetes Self-Management Behaviors - Specific Diet(Baseline; immediate post-intervention (approx. 20 weeks))
  • Type 2 Diabetes Self-Management Behaviors - Exercise(Baseline; immediate post-intervention (approx. 20 weeks))
  • Type 2 Diabetes Self-Management Behaviors - Blood Glucose Testing(Baseline; immediate post-intervention (approx. 20 weeks))
  • Type 2 Diabetes Self-Management Behaviors - Foot Care(Baseline; immediate post-intervention (approx. 20 weeks))
  • Type 2 Diabetes Self-Management Behaviors - Smoking(Baseline; immediate post-intervention (approx. 20 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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