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Study Title: Food Rx

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ClinicalTrials.gov Identifier: NCT03937934
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Erin C. Westfall, 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.

Condition or disease Intervention/treatment Phase
Diabetes High Blood Pressure Obesity Hypertension Heart Diseases Stroke TIA Osteoarthritis Cancer Behavioral: Nutrition Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Study Title: Food Rx
Estimated Study Start Date : May 20, 2019
Estimated Primary Completion Date : November 20, 2019
Estimated Study Completion Date : May 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Subjects with long term health condition
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
Weekly box of healthy groceries and nutrition education including a recipe, food to make the recipe, extra fruit and vegetables.




Primary Outcome Measures :
  1. Change in the number of self-reported fruits per day [ Time Frame: Baseline, 3 months, 6 months ]
    Number of self-reported fruits per day

  2. Change in the number of self-reported vegetables per day [ Time Frame: Baseline, 3 months, 6 months ]
    Number of self-reported vegetables per day

  3. 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 Outcome Measures :
  1. Change in A1c [ Time Frame: 6 months and 12 months ]
    Identified through chart review

  2. Change in BMI kg/m2 (weight in kg, height in meters) [ Time Frame: 6 months and 12 months ]
    Identified through chart review

  3. Change in Systolic and/or Diastolic Hypertension mmHg [ Time Frame: 6 months and 12 months ]
    Identified through chart review



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937934


Contacts
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Contact: Erin Westfall, DO 507-594-6500 Westfall.erin@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Health System Recruiting
Mankato, Minnesota, United States, 56001
Contact: Erin Westfall, DO    507-594-6500      
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Erin Westfall, DO Mayo Clinic

Additional Information:
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Responsible Party: Erin C. Westfall, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03937934     History of Changes
Other Study ID Numbers: 18-006630
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Osteoarthritis
Heart Diseases
Hypertension
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Cardiovascular Diseases
Vascular Diseases