Study Title: Food Rx
Primary Purpose
Diabetes, High Blood Pressure, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutrition Education
Sponsored by

About this trial
This is an interventional health services research trial for Diabetes
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
Sites / Locations
- Mayo Clinic Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects with long term health condition
Arm Description
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
Outcomes
Primary Outcome Measures
Change in the number of self-reported fruits per day
Number of self-reported fruits per day
Change in the number of self-reported vegetables per day
Number of self-reported vegetables per day
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
Secondary Outcome Measures
Change in A1c
Identified through chart review
Change in BMI kg/m2 (weight in kg, height in meters)
Identified through chart review
Change in Systolic and/or Diastolic Hypertension mmHg
Identified through chart review
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03937934
Brief Title
Study Title: Food Rx
Official Title
Study Title: Food Rx
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 20, 2019 (Actual)
Primary Completion Date
November 20, 2019 (Actual)
Study Completion Date
May 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, High Blood Pressure, Obesity, Hypertension, Heart Diseases, Stroke, TIA, Osteoarthritis, Cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects with long term health condition
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Education
Intervention Description
Weekly box of healthy groceries and nutrition education including a recipe, food to make the recipe, extra fruit and vegetables.
Primary Outcome Measure Information:
Title
Change in the number of self-reported fruits per day
Description
Number of self-reported fruits per day
Time Frame
Baseline, 3 months, 6 months
Title
Change in the number of self-reported vegetables per day
Description
Number of self-reported vegetables per day
Time Frame
Baseline, 3 months, 6 months
Title
Change in number of days a week and minutes per day participants participate in physical activity and sedentary activity
Description
Measured using self-reported Food Rx Pilot survey
Time Frame
Baseline, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Change in A1c
Description
Identified through chart review
Time Frame
6 months and 12 months
Title
Change in BMI kg/m2 (weight in kg, height in meters)
Description
Identified through chart review
Time Frame
6 months and 12 months
Title
Change in Systolic and/or Diastolic Hypertension mmHg
Description
Identified through chart review
Time Frame
6 months and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Westfall, DO
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Health System
City
Mankato
State/Province
Minnesota
ZIP/Postal Code
56001
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Study Title: Food Rx
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