Farm to Clinic Vegetable Initiative at East Baltimore Medical Center
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
Healthy food and Education/Cooking Classes
At consent, participant will complete the baseline survey. Baseline survey will collect information like vegetable consumption, healthy eating attitudes, and demographics. Every week for 6 weeks, participants will pick-up a healthy food bag (e.g. fresh vegetables) for a $3 co-pay and attend an hour-long education classes at East Baltimore Medical Center. All participants will complete a survey at healthy food bag pick-up or an education class. Surveys at bag pick-up will ascertain outcomes like vegetable consumption. Surveys at education classes will ascertain outcomes like healthy eating attitudes. At 6 weeks, all participants will complete a follow-up survey equivalent to the baseline survey. The follow-up survey will be completed again at 10 weeks, 18 weeks, and 30 weeks. Participants will also be weighed at each bag pick-up (participants may decline) and relevant health information like blood pressure will be obtained from the EMR from an associated office visit.
干预措施: Healthy food and Education/Cooking Classes (Behavioral)
Control Group
At consent, participant will complete the baseline survey. Baseline survey will collect information like vegetable consumption, cooking habits, food security, healthy eating attitudes, and demographics. As a control group, participants will not partake in the healthy food bag pick-ups or cooking classes therefore they will not fill out those associated surveys. After the 6 weeks of the intervention, control participants will be given the follow-up survey equivalent to the baseline survey. The follow-up survey will be completed again after 10 weeks, 18 weeks, and 30 weeks. Participants will also be weighed at each bag pick-up (participants may decline) and relevant health information like blood pressure will be obtained from the EMR from an associated office visit.
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)