Study Title: Food Rx

Not Applicable

Completed

• Conditions: Stroke; Obesity; Hypertension; Heart Diseases; Osteoarthritis; Cancer; Diabetes; High Blood Pressure; TIA
• Interventions: Behavioral: Nutrition Education

• Registration Number: NCT03937934
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2019-04-30
• Study First Submitted QC: 2019-05-01
• Study First Posted: 2019-05-06
• Study Start: 2019-05-20
• Primary Completion: 2019-11-20
• Study Completion: 2020-05-20
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-05
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects with long term health condition	Nutrition Education	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in A1c	6 months and 12 months	Identified through chart review
Change in BMI kg/m2 (weight in kg, height in meters)	6 months and 12 months	Identified through chart review
Change in Systolic and/or Diastolic Hypertension mmHg	6 months and 12 months	Identified through chart review

Trial Locations

Locations (1)

Mayo Clinic Health System; 🇺🇸 Mankato, Minnesota, United States