Study Title: Food Rx

Study Overview
=================
Brief Summary
-----------------
Researchers are trying to determine if subjects with lack of access to healthy food and a long term health problem, are helped by a weekly box of healthy groceries and nutrition education.

Detailed Description
-----------------
Participants that have a chronic preventable disease and food insecurity will be offered enrollment in the study. Once all participants are enrolled, they will be given weekly boxes of food which includes materials for a nutritious recipe and extra fruit and vegetables for a total of 6 weeks. The SNAP-Ed Educator and SHIP Public health coordinator will be present at food pick up to answer questions about the boxes, food preparation, etc. They will be given the option of participating in grocery store and farmer's market tours, as well as sign up for text messaging of nutrition information and recipes. At the end of 6 weeks, they will be asked to participate in a focus group. At baseline, 3 months and 6 months, they will be asked to complete a survey on lifestyle behaviors and food choices.

Official Title
-----------------
Study Title: Food Rx

Conditions
-----------------
TIA, Diabetes, High Blood Pressure, Obesity, Hypertension, Heart Diseases, Stroke, Osteoarthritis, Cancer

Intervention / Treatment
-----------------
* Behavioral: Nutrition Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients that have been identified as having food insecurity based on a two question screening tool, AND Also has one of more of the following chronic diseases: Hypertension, Heart disease, Stroke/TIA, DM 2, Cancer/history of cancer, obesity osteoarthritis Exclusion Criteria: Pregnant women Children

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with long term health condition<br>Subjects that have been identified as having food insecurity based on a two question screening tool, and also has one of more of the following chronic diseases Hypertension, Heart disease, Stroke/TIA, DM 2, Cancer/history of cancer, obesity or osteoarthritis will receive weekly nutrition educaiton | Behavioral: Nutrition Education<br>* Weekly box of healthy groceries and nutrition education including a recipe, food to make the recipe, extra fruit and vegetables.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the number of self-reported fruits per day | Number of self-reported fruits per day | Baseline, 3 months, 6 months | 
| Change in the number of self-reported vegetables per day | Number of self-reported vegetables per day | Baseline, 3 months, 6 months | 
| Change in number of days a week and minutes per day participants participate in physical activity and sedentary activity | Measured using self-reported Food Rx Pilot survey | Baseline, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in A1c | Identified through chart review | 6 months and 12 months | 
| Change in BMI kg/m2 (weight in kg, height in meters) | Identified through chart review | 6 months and 12 months | 
| Change in Systolic and/or Diastolic Hypertension mmHg | Identified through chart review | 6 months and 12 months |