Fresh Food Farmacy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- HbA1c
研究概览
简要总结
This trial investigates the value created by the highly innovative Fresh Food Farmacy (FFF) program at Geisinger Health. The program provides food-insecure diabetics with healthy food for their entire household: at least two meals per day, five days a week. The program also provides education on how to prepare the food, and education on healthy living including diabetes self management. The research measures the effects of the FFF program on patient health and wellbeing.
详细描述
This is a pragmatic, prospective, randomized controlled trial of Geisinger's Fresh Food Farmacy (FFF) program as the program expands to new sites. Qualifying subjects will be randomized 1:1 to receive either early participation in the FFF program (treatment group) or later participation (control group).
Approximately 500 Geisinger subjects will participate in this study with about half assigned to the treatment group and about half to the control group. The treatment group will begin the program soon after trial recruitment: the "Begin Now" group. The control group will begin the program after 6 months: the "Begin Later" group. Approximately 2000 household members will be included in the data-only portion of the research.
Outcomes will include clinical measures, such as HbA1c, survey responses including self-assessed health measures, and utilization / healthy-behavior measures from EHR and paid claims data. These will be measured for subjects and their household members.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type II Diabetes and an HbA1c ≥ 8.0 as determined by the most recent measurement in the Geisinger EMR within the prior 12 months
- •Food insecure based on a two-question survey instrument
- •Age > 17 & Age <86
- •Living within geographic reach of the program (Lewistown, PA and Scranton, PA)
排除标准
- •Already enrolled in FFF in Shamokin
- •Not English speaking (working on changing this as the program evolves)
- •On hospice or palliative care
- •Acute or chronic psychosis
- •Resides in a facility which provides meals
- •Active medical disorder that would preclude participation in the classes, weekly clinic visits, or result in a limited diet, including:
- •Cancer; active treatment
- •Steroid dependent asthma/ COPD/ emphysema
- •Steroid dependent Colitis
- •Chronic Kidney Disease with GFR< 30 mg/mmol
- •Celiac disease
- •Cirrhosis
- •Steroid dependent arthritis
结局指标
主要结局
HbA1c
时间窗: 6 months after trial enrollment
Glycated hemoglobin (HbA1c) is a measure of the average share of glucose that has been in the bloodstream over the 2-3 months preceding measurement. HbA1c is measured by performing assays on samples of the participants' blood. Units are percentages; for differences between HbA1c values, units are percentage points. An HbA1c value of 6.5% is the lower threshold for type 2 diabetes. HbA1c values are rarely above 15-20%. In the context of this study (patients with type 2 diabetes), higher scores are considered a worse outcome.
次要结局
- HbA1c(12 months after trial enrollment)
- Fasting Glucose(6 and 12 months after trial enrollment)
- Weight (lb)(6 and 12 months after trial enrollment)
- Body Mass Index(6 and 12 months after trial enrollment)
- Total Cholesterol(6 and 12 months after trial enrollment)
- LDL Cholesterol(6 and 12 months after trial enrollment)
- HDL Cholesterol(6 and 12 months after trial enrollment)
- Triglycerides(6 and 12 months after trial enrollment)
- Systolic Blood Pressure(6 and 12 months after trial enrollment)
- Diastolic Blood Pressure(6 and 12 months after trial enrollment)
- Times Eating Fruit in the Past 7 Days(6 and 12 months after trial enrollment)
- Times Eating Dark Green Vegetables in the Past 7 Days(6 and 12 months after trial enrollment)
- Times Drinking Sweetened Beverages in the Past 7 Days(6 and 12 months after trial enrollment)
- Times Eating Out in the Past 7 Days(6 and 12 months after trial enrollment)
- Participants Answering "Yes" for Diet Improvement Compared to One Year Ago(6 and 12 months after trial enrollment)
- Mean Proportion of Diabetes Knowledge Questions Answered Correctly(6 and 12 months after trial enrollment)
- Engagement Index Score(6 and 12 months after trial enrollment)
- Number of Outpatient Visits Claimed by Insurance(6 and 12 months after trial enrollment)
- Number of Inpatient and Emergency Department Visits Claimed by Insurance(6 and 12 months after trial enrollment)
- Proportion of Participants Filing Outpatient Insurance Claims With Insurance(6 and 12 months after trial enrollment)
- Proportion of Participants Filing Inpatient or Emergency Department Claims With Insurance(6 and 12 months after trial enrollment)
- Inpatient and Emergency Department Payments(6 and 12 months after trial enrollment)
- Outpatient Payments(6 and 12 months after trial enrollment)
- Number of Visits to a Dietician(6 and 12 months after trial enrollment)
- Number of Diabetes Self-Management Trainings Completed(6 and 12 months after trial enrollment)
- Number of Visits to an Endocrinologist(6 and 12 months after trial enrollment)
- Number of Weight Loss and Weight Management Appointments Completed(6 and 12 months after trial enrollment)
研究者
John B Bulger, DO
Chief Health Officer, GIO
Geisinger Clinic