Impact of Food Distribution at Low-income Clinics on Health Outcomes of Patients With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 主要终点
- Change in HbA1c (measured as part of routine care)
研究概览
简要总结
To compare the effectiveness of providing monthly boxes of nutritious foods to low-income patients with diabetes on site at Free Clinics with referrals to off-site food pantries on diabetes related health outcomes
详细描述
It is hypothesized that providing healthy foods may stabilize unhealthy eating patterns for diabetics so that HbA1c measurements significantly improve. The UCSD Student-Run Free Clinic Project (SRFCP) will offer boxes of nutritious food monthly along with a brief nutrition class to its diabetic patients and continue their otherwise usual care. The UCSD SRFCP will partner with a large food bank, Feeding America San Diego, that can provide monthly food boxes of healthy food along with education about eating healthy on a budget. Food insecurity negatively impacts health outcomes in diabetic patients; therefore enhancing food security with nutritious food as well as providing education to cultivate healthy eating habits could be a cost-effective way to improve health outcomes in diabetics, necessitating the use of human subjects for this study. Blood pressure, weight, and LDL cholesterol will be secondary outcome measures along with survey measures for diabetes distress, depression, dietary quality assessment, medication adherence, hypoglycemia, and food security.
Diabetics who enroll in this study will be randomly assigned to an initial 3-month period of either immediate intervention (the food boxes and education) or a wait list control group. The intervention involves receiving a box of nutritious food each month along with brief education provided by food pantry staff, in addition to usual medical care. In measuring clinical outcomes, this study will not deviate from routine care.
As a part of routine care screening, all UCSD SRFCP patients will receive the six-item 'Short Form' of the USDA Food Security Survey Module to assess their food security upon arrival in the waiting area. This survey will be self-administered or orally administered depending on patient preference. Regardless of food security status, everyone will be offered referral to local food banks and referral for Cal-Fresh (Food Stamps) application if eligible.
All patients who receive care at the UCSD SRFCP sites with a diagnosis of diabetes, regardless of food security status, will be offered these same resources in addition to being informed of this study. The investigators will track health outcomes from routine clinical visits by querying the electronic health records if patients chose to participate in the study. Participants will also be asked to complete a survey at baseline, 3 months, 6 months, and 9 months (for the wait list group). Those who are interested in the study will speak with a study coordinator and be provided a detailed discussion about the study.
Once the study is fully explained and ample time is given for patients to make a well-informed decision, the informed consent will be obtained in a private room or space with study coordinators fluent in the patient's preferred language (English or Spanish) who are capable of answering questions about the study. The informed consent forms will be provided in English and Spanish. It will be made clear to patients that they are under no obligation to participate and that refusal to participate in no way influences the routine care they receive at the UCSD SRFCP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •type 2 diabetes
- •receiving medical care at one of the UC San Diego Student-run Free Clinic Sites
排除标准
- •unable to attend monthly food distribution onsite (pt states will not able to come monthly due to any kind of conflict (work, transportation, childcare), or is not interested in coming monthly due to time or transportation burden)
研究组 & 干预措施
Immediate intervention
Intervention: Food boxes. Monthly boxes of food for 6 months, along with brief educational information from food pantry staff regarding eating healthy on a budget, starting immediately after randomization. Patients will continue to receive routine medical care at the Free Clinic.
干预措施: Food boxes (Other)
Delayed intervention
Intervention: Food boxes. Monthly boxes of food for 6 months, along with brief educational information from food pantry staff regarding eating healthy on a budget, starting 3 months after randomization. Patients will continue to receive routine medical care at the Free Clinic. Participants will be given referrals to local food pantries in their neighborhoods that provide food free of charge as well as referrals for CalFresh (formerly known as food stamps) during the 3 month time frame when patients are waiting to receive food distributions on site at the clinics.
干预措施: Food boxes (Other)
结局指标
主要结局
Change in HbA1c (measured as part of routine care)
时间窗: primary outcome measure is change in HbA1c from baseline to 3 months, 6 months, 9 months (9months is for delayed intervention only)
次要结局
- Change in Body Mass Index, measured in kg/m^2, weight in kilograms, height in meters(baseline, 3 months, 6 months, 9 months (9 months is for delayed intervention only))
- Change in Food Insecurity(baseline, 3 months, 6 months, 9 months (9 months is for delayed intervention only))
- Change in Diabetes Distress(baseline, 3 months, 6 months, 9 months (9 months is for delayed intervention only))
- Change in Fruit and Vegetable Intake(baseline, 3 months, 6 months, 9 months (9 months is for delayed intervention only))
- Change in Hypoglycemic Events(baseline, 3 months, 6 months, 9 months (9 months is for delayed intervention only))
- Change in Medication adherence(baseline, 3 months, 6 months, 9 months (9 months is for delayed intervention only))
- Change in Blood Pressure (systolic and diastolic)(baseline, 3 months, 6 months, 9 months (9 months is for delayed intervention only))
- Change in LDL(baseline, 3 months, 6 months, 9 months (9 months is for delayed intervention only))
- Change in weight (in pounds) and Body Mass Index(baseline, 3 months, 6 months, 9 months (9 months is for delayed intervention only))
研究者
Sunny Smith
Clinical Professor, Department of Family Medicine and Public Health
University of California, San Diego
