Study Title: Food Rx
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes
Started May 2019
Shorter than P25 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2019
CompletedFirst Posted
Study publicly available on registry
May 6, 2019
CompletedStudy Start
First participant enrolled
May 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2020
CompletedJune 9, 2020
June 1, 2020
6 months
April 30, 2019
June 5, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Change in the number of self-reported fruits per day
Number of self-reported fruits per day
Baseline, 3 months, 6 months
Change in the number of self-reported vegetables per day
Number of self-reported vegetables per day
Baseline, 3 months, 6 months
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
Baseline, 3 months, 6 months
Secondary Outcomes (3)
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 Arms (1)
Subjects with long term health condition
EXPERIMENTALSubjects 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
Interventions
Weekly box of healthy groceries and nutrition education including a recipe, food to make the recipe, extra fruit and vegetables.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant women
- Children
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic Health System
Mankato, Minnesota, 56001, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erin Westfall, DO
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 30, 2019
First Posted
May 6, 2019
Study Start
May 20, 2019
Primary Completion
November 20, 2019
Study Completion
May 20, 2020
Last Updated
June 9, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share