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临床试验/NCT03991026
NCT03991026已完成不适用

Farm to Clinic Vegetable Initiative at East Baltimore Medical Center

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2019年6月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
Change in amount of vegetables eaten

研究概览

简要总结

The investigators will study a program that delivers weekly community-supported agriculture shares to patients of East Baltimore Medical Center in order to increase access to healthy foods. The investigators will provide adult patients with uncontrolled diabetes with healthy foods including fresh vegetables and shelf-stable pantry items (e.g., canned beans) every week over the course of 6 weeks. The investigators will also collect demographic data and food insecurity status of participants via survey. This program will also conduct weekly cooking and nutrition classes at East Baltimore Medical Center. The investigators will conduct a survey of participants' experiences each time participants pick up a vegetable bag and at the end of the cooking classes. In addition, a focus group of participants will be held to gather qualitative data regarding the vegetable initiative.

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

入选标准

  • Patients with uncontrolled diabetes mellitus (defined as a glycosylated hemoglobin >8%)
  • 18 years age of and over
  • Living within the geographical region of East Baltimore Medical Campus

排除标准

  • Current participation in Five Plus Nuts and Beans Study or other program that provides diet-based food
  • Non-English speaking
  • On hospice or palliative care
  • Acute or chronic psychosis
  • Active substance or alcohol use disorder
  • Another active medical disorder that would preclude participation in weekly food pick-up or classes including: active treatment of cancer, steroid dependent asthma/chronic obstructive pulmonary disease/emphysema, steroid dependent colitis; chronic kidney disease with an estimated glomerular filtration rate less than 30mg/mmol, venous thromboembolic disease with current treatment with vitamin K antagonist, Celiac disease, cirrhosis or steroid dependent arthritis

结局指标

主要结局

Change in amount of vegetables eaten

时间窗: Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks

Self-reported number of vegetables eaten per day (e.g. 2 vegetables/day) will be obtained by the survey.

Change in Body mass index (kg/m^2)

时间窗: Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks

Recorded from EMR or calculated with height of record.

Change in weight (kg)

时间窗: Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks

Recorded from Electronic Medical Record (EMR) or weighed at weekly bag pick-up.

次要结局

  • Change in Glycosylated Hemoglobin level (percent of mmol/mol)(Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks)
  • Change in Blood pressure (mmHg)(Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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