Study Title: Food Rx

Obesity Clinical Trial

Official title:

Study Title: Food Rx

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03937934
• Other study ID #: 18-006630
• Status: Completed
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: May 20, 2020

Study information

• Verified date: June 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 20, 2020
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Diabetes
• Heart Diseases
• High Blood Pressure
• Hypertension
• Obesity
• Osteoarthritis
• Stroke
• TIA

Intervention

Behavioral:
• Nutrition Education
Weekly box of healthy groceries and nutrition education including a recipe, food to make the recipe, extra fruit and vegetables.

Locations

Country	Name	City	State
United States	Mayo Clinic Health System	Mankato	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the number of self-reported fruits per day	Number of self-reported fruits per day	Baseline, 3 months, 6 months
Primary	Change in the number of self-reported vegetables per day	Number of self-reported vegetables per day	Baseline, 3 months, 6 months
Primary	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	Change in A1c	Identified through chart review	6 months and 12 months
Secondary	Change in BMI kg/m2 (weight in kg, height in meters)	Identified through chart review	6 months and 12 months
Secondary	Change in Systolic and/or Diastolic Hypertension mmHg	Identified through chart review	6 months and 12 months

External Links

•   Mayo Clinic Clinical Trials