DiabetesNCT03937934
Study Title: Food Rx
A study testing Nutrition Education in people with Diabetes and High Blood Pressure, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, High Blood Pressure, Obesity
- What is being tested?
- Nutrition Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2019to 20 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 9Show fewer
- Cancer/history of cancer,
- obesity
- osteoarthritis
Who cannot join
- Pregnant women
- Children
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetes, High Blood Pressure, Obesity, Hypertension, Heart Diseases, Stroke
- Being tested
- Nutrition Education
- Medical subject headings
- Diabetes Mellitus, Hypertension, Obesity, Heart Diseases, Stroke, Osteoarthritis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition EducationBehavioural
Weekly box of healthy groceries and nutrition education including a recipe, food to make the recipe, extra fruit and vegetables.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with long term health condition | Experimental | 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 Receives: Behavioral: Nutrition Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of self-reported fruits per day
Number of self-reported fruits per day
Measured: Baseline, 3 months, 6 months
Change in the number of self-reported vegetables per day
Number of self-reported vegetables per day
Measured: 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
Measured: Baseline, 3 months, 6 months
Secondary outcomes (3)
Change in A1c
Identified through chart review
Measured: 6 months and 12 months
Change in BMI kg/m2 (weight in kg, height in meters)
Identified through chart review
Measured: 6 months and 12 months
Change in Systolic and/or Diastolic Hypertension mmHg
Identified through chart review
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start20 May 2019
- Primary completion20 Nov 2019
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin C. Westfall, Mayo Clinic
- Investigators
- Erin Westfall, DO, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937934
- Sponsor's protocol ID
- 18-006630
- Status last verified
- Jun 2020
- First submitted
- 30 Apr 2019
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Title: Food Rx
- ClinicalTrials.gov ID
- NCT03937934
- Acronym / sponsor ID
- 18-006630
- Conditions
- Diabetes, High Blood Pressure, Obesity, Hypertension, Heart Diseases, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with long term health condition | Experimental | Behavioral: Nutrition EducationSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (2 listed)
- Pregnant women
- Children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition EducationWeekly box of healthy groceries and nutrition education including a recipe, food to make the recipe, extra fruit and vegetables. | Behavioural | Subjects with long term health condition |
Primary outcome
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 the number of self-reported vegetables per day
Time frame: Baseline, 3 months, 6 months
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
Time frame: Baseline, 3 months, 6 months
Measured using self-reported Food Rx Pilot survey
3 secondary outcomes
Change in A1c
Time frame: 6 months and 12 months
Change in BMI kg/m2 (weight in kg, height in meters)
Time frame: 6 months and 12 months
Change in Systolic and/or Diastolic Hypertension mmHg
Time frame: 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Westfall, DO principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Education in people with Diabetes and High Blood Pressure, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of self-reported fruits per day (time frame: Baseline, 3 months, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020; AzTrials last refreshed its copy on 30 Oct 2026.