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Fruit And Vegetable Or Recreation Prescriptions for UW-Madison Students (FAVORx)

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fruit and Vegetable CSA Prescription
Bikeshare Prescription
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring overweight, obesity, lifestyle prescription, prevention, physical activity, healthy eating

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Is 18 years of age or older
  2. Seeking healthcare from UW UHS
  3. Is enrolled at UW-Madison for next academic year
  4. BMI >25
  5. Living off-campus for following year, and not with parents or guardians
  6. Basic English fluency and literacy

Exclusion Criteria:

  1. Currently exercises more than 2 times per week for 30 minutes or more
  2. Participant is pregnant or plans to be pregnant
  3. Regularly rides a bicycle (more than 1-2 times per month)
  4. Currently participates or has already participated in a fruit /vegetable CSA share

Sites / Locations

  • University of Wisconsin - Madison

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Fruit and Vegetable CSA Prescription

Bikeshare Prescription

Control

Arm Description

Study participants randomized to the "CSA group" will be expected to pick up their weekly CSA box at University Health Services and to commit to using and consuming as much of the produce as they are able. CSA group participants will also be required to attend two cooking and food preparation classes coordinated by Slow Food UW. The classes will teach study participants how to properly clean and prepare the fruits and vegetables from a weekly CSA box, and also offer techniques and show them how to cook the foods in a healthy manner. These classes will also educate study participants on the benefits of eating fruits and vegetables and buying them from local farmers. These two classes will only exist for study participants in this fruit and veggie CSA group. Participants in the "CSA group" will also be required to take a field trip to the farm providing their CSA share, which will offer the opportunity for participants to gain a better understanding of from where their food comes.

Study participants randomized to the "bikeshare group" will be expected to use B-cycle bikes for transportation and/or recreation as much as is safe and appropriate. Bikeshare group participants will be required to attend one bicycle use/safety course. This course will introduce the B-cycle program, demonstrate use of the B-cycle station, provide information use of helmets and safety gear, and provide information on the basics of cycling and keeping yourself safe and comfortable while riding in traffic. The study participants in this group will also be required to attend a class on the benefits of exercise, including bicycling, among other forms of physical activity. This class will be offered by the University Health Services Wellness program. B-cycle usage, including estimated distance traveled and frequency of use, will be tracked via the B-cycle Madison website.

Study participants in the control group will receive continued "usual care" from University Health Services providers, which includes educational brochures on healthy eating and exercising, plus a cash payment. Control group participants are not part of a wait-list group.

Outcomes

Primary Outcome Measures

Change in Body Mass Index
Change in Body Mass Index in kg/m^2 will be calculated using the participant weight (kg) and height (meters) measured at Baseline and Follow-Up visits, which will be approximately a 16-18 week timeframe over the intervention period.

Secondary Outcome Measures

Fasting Lipid Panel
Fasting Lipid Panel will be collected at Baseline and at Follow-Up, which will be approximately a 12-16 week timeframe.
Glycated Hemoglobin (HgA1c)
Glycated Hemoglobin will be collected at Baseline and at Follow-Up, which will be approximately a 12-16 week timeframe.
Blood Pressure
Blood Pressure will be taken at Baseline and at Follow-Up, which will be approximately a 12-16 week timeframe.

Full Information

First Posted
July 28, 2016
Last Updated
October 24, 2017
Sponsor
University of Wisconsin, Madison
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02870322
Brief Title
Fruit And Vegetable Or Recreation Prescriptions for UW-Madison Students
Acronym
FAVORx
Official Title
Measuring the Feasibility of Fruit and Vegetable or Recreation Prescriptions Among UW-Madison Students
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
October 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This research will use randomized controlled trial (RCT) methodology to assess the feasibility of a prescription for fruit/vegetable CSA shares or exercise by bikeshare on obesity-related outcomes. Three cohorts of n=10 University of Wisconsin-Madison (UW) students (total 30) will be randomized to three groups: (1) a 10-week fruit and vegetable community supported agriculture (CSA) share prescription program with vegetable education and cooking support from UW Slow Food; (2) a 10-week Madison B-cycle bikeshare membership prescription program with exercise support or (3) a non-interventional wait-list control group. The primary outcome will be change in Body Mass Index (BMI) (a measure of obesity using a person's weight in kilograms divided by his or her height in meters squared). Secondary outcomes will be fasting lipids, blood pressure, and glycated hemoglobin (HGA1c) levels. All of these measures will be tested at baseline and just after the 10-week intervention
Detailed Description
This research will use randomized controlled trial (RCT) methodology to assess the feasibility of a prescription by University Health Services (UHS) Providers for fruit/vegetable CSA shares or exercise by bikeshare on obesity-related outcomes. Three cohorts of n=10 UW-Madison students (total 30) will be randomized to three groups: (1) a 10-week fruit and vegetable community supported agriculture (CSA) share prescription program with vegetable education and cooking support from UW Slow Food; (2) a 10-week Madison B-cycle bikeshare membership prescription program with exercise support from the UHS wellness program; or (3) a non-interventional wait-list control group. The primary outcome will be change in Body Mass Index (a measure of obesity using a person's weight in kilograms divided by his or her height in meters squared). Secondary outcomes will be fasting lipids, blood pressure, and HGA1c levels. All of these measures will be tested at baseline and just after the 10-week intervention. Fasting lipids and HGA1c levels will be assessed through a blood draw. Study participants will be asked to refrain from eating or drinking anything except for water 8-12 hours prior to the blood draw. Study participants will fill out validated questionnaires assessing perceived stress, physical activity levels, self-efficacy, social support, and general mental and physical health at baseline and after the intervention. Study participants will also conduct a 3 day dietary recall before and after the intervention. Study participants randomized to the "CSA group" will be expected to pick up their weekly CSA box at University Health Services and to commit to using and consuming as much of the produce as they are able. CSA group participants will also be required to attend two cooking and food preparation classes coordinated by Slow Food UW. The classes will teach study participants how to properly clean and prepare the fruits and vegetables from a weekly CSA box, and also offer techniques and show them how to cook the foods in a healthy manner. These classes will also educate study participants on the benefits of eating fruits and vegetables and buying them from local farmers. These two classes will only exist for study participants in this fruit and veggie CSA group. Participants in the "CSA group" will also be required to take a field trip to the farm providing their CSA share, which will offer the opportunity for participants to gain a better understanding of from where their food comes. Study participants randomized to the "bikeshare group" will be expected to use B-cycle bikeshare bicycles for transportation and/or recreation as much as is safe and appropriate. Bikeshare group participants will be required to attend two bicycle use/safety courses. These courses will introduce the B-cycle program, demonstrate use of the B-cycle station, provide information use of helmets and safety gear, and provide information on the basics of cycling and keeping yourself safe and comfortable while riding a B-cycle bike in traffic. B-cycle usage, including estimated distance traveled and frequency of use, will be tracked via the B-cycle Madison website. Study participants in the control group will receive continued "usual care" from University Health Services providers, which includes educational brochures on healthy eating and exercising. Control group participants are not part of a wait-list group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
overweight, obesity, lifestyle prescription, prevention, physical activity, healthy eating

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fruit and Vegetable CSA Prescription
Arm Type
Active Comparator
Arm Description
Study participants randomized to the "CSA group" will be expected to pick up their weekly CSA box at University Health Services and to commit to using and consuming as much of the produce as they are able. CSA group participants will also be required to attend two cooking and food preparation classes coordinated by Slow Food UW. The classes will teach study participants how to properly clean and prepare the fruits and vegetables from a weekly CSA box, and also offer techniques and show them how to cook the foods in a healthy manner. These classes will also educate study participants on the benefits of eating fruits and vegetables and buying them from local farmers. These two classes will only exist for study participants in this fruit and veggie CSA group. Participants in the "CSA group" will also be required to take a field trip to the farm providing their CSA share, which will offer the opportunity for participants to gain a better understanding of from where their food comes.
Arm Title
Bikeshare Prescription
Arm Type
Active Comparator
Arm Description
Study participants randomized to the "bikeshare group" will be expected to use B-cycle bikes for transportation and/or recreation as much as is safe and appropriate. Bikeshare group participants will be required to attend one bicycle use/safety course. This course will introduce the B-cycle program, demonstrate use of the B-cycle station, provide information use of helmets and safety gear, and provide information on the basics of cycling and keeping yourself safe and comfortable while riding in traffic. The study participants in this group will also be required to attend a class on the benefits of exercise, including bicycling, among other forms of physical activity. This class will be offered by the University Health Services Wellness program. B-cycle usage, including estimated distance traveled and frequency of use, will be tracked via the B-cycle Madison website.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Study participants in the control group will receive continued "usual care" from University Health Services providers, which includes educational brochures on healthy eating and exercising, plus a cash payment. Control group participants are not part of a wait-list group.
Intervention Type
Behavioral
Intervention Name(s)
Fruit and Vegetable CSA Prescription
Intervention Description
Study Participants will collect and use fruit and vegetable CSA boxes given to them weekly for 10 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Bikeshare Prescription
Intervention Description
Study participants will use bikeshare for transportation and physical activity for 10 weeks
Primary Outcome Measure Information:
Title
Change in Body Mass Index
Description
Change in Body Mass Index in kg/m^2 will be calculated using the participant weight (kg) and height (meters) measured at Baseline and Follow-Up visits, which will be approximately a 16-18 week timeframe over the intervention period.
Time Frame
Between Baseline and Follow-Up visits for a total of 16-18 weeks
Secondary Outcome Measure Information:
Title
Fasting Lipid Panel
Description
Fasting Lipid Panel will be collected at Baseline and at Follow-Up, which will be approximately a 12-16 week timeframe.
Time Frame
Baseline, 12 - 16 weeks
Title
Glycated Hemoglobin (HgA1c)
Description
Glycated Hemoglobin will be collected at Baseline and at Follow-Up, which will be approximately a 12-16 week timeframe.
Time Frame
Baseline, 12 -16 weeks
Title
Blood Pressure
Description
Blood Pressure will be taken at Baseline and at Follow-Up, which will be approximately a 12-16 week timeframe.
Time Frame
Baseline, 12 - 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Is 18 years of age or older Seeking healthcare from UW UHS Is enrolled at UW-Madison for next academic year BMI >25 Living off-campus for following year, and not with parents or guardians Basic English fluency and literacy Exclusion Criteria: Currently exercises more than 2 times per week for 30 minutes or more Participant is pregnant or plans to be pregnant Regularly rides a bicycle (more than 1-2 times per month) Currently participates or has already participated in a fruit /vegetable CSA share
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce P Barrett, MD, PhD
Organizational Affiliation
Professor, Clinician
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Fruit And Vegetable Or Recreation Prescriptions for UW-Madison Students

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