search
Back to results

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
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 30, 2019
Last Updated
June 5, 2020
Sponsor
Mayo Clinic
search

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

We'll reach out to this number within 24 hrs