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Clinical Trials/NCT03937934
NCT03937934
Completed
Not Applicable

Study Title: Food Rx

Mayo Clinic1 site in 1 country24 target enrollmentMay 20, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Diseases
Sponsor
Mayo Clinic
Enrollment
24
Locations
1
Primary Endpoint
Change in the number of self-reported vegetables per day
Status
Completed
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
May 20, 2019
End Date
May 20, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Erin C. Westfall

Principal Investigator

Mayo Clinic

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,
  • Cancer/history of cancer,
  • osteoarthritis

Exclusion Criteria

  • Pregnant women

Outcomes

Primary Outcomes

Change in the number of self-reported vegetables per day

Time Frame: Baseline, 3 months, 6 months

Number of self-reported vegetables per day

Change in the number of self-reported fruits per day

Time Frame: 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

Time Frame: Baseline, 3 months, 6 months

Measured using self-reported Food Rx Pilot survey

Secondary Outcomes

  • Change in A1c(6 months and 12 months)
  • Change in BMI kg/m2 (weight in kg, height in meters)(6 months and 12 months)
  • Change in Systolic and/or Diastolic Hypertension mmHg(6 months and 12 months)

Study Sites (1)

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