Skip to main content
OpenTrials
Completed

NCT Number: NCT03937934

Study Title: Food Rx

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Arthritis Body Weight Brain Diseases Cancer Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases High Blood Pressure Hypertension Joint Diseases Metabolic Diseases Musculoskeletal Diseases Neoplasms Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Osteoarthritis Overnutrition Overweight Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Stroke TIA Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Health System

Mankato, Minnesota, 56001, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrition Education

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
May 6, 2019
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.