OverweightFAVORxNCT02870322
Fruit And Vegetable Or Recreation Prescriptions for UW-Madison Students
A study testing Fruit and Vegetable CSA Prescription and Bikeshare Prescription in people with Overweight and Obesity, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Fruit and Vegetable CSA Prescription and Bikeshare Prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 24 Oct 2017
- 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 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin - Madison
Madison, Wisconsin, 53715
About this study
Official title: Measuring the Feasibility of Fruit and Vegetable or Recreation Prescriptions Among UW-Madison Students
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
Read the 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.
- Conditions
- Overweight, Obesity
- Being tested
- Fruit and Vegetable CSA Prescription, Bikeshare Prescription
- Keywords
- overweight, obesity, lifestyle prescription, prevention, physical activity, healthy eating
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruit and Vegetable CSA PrescriptionBehavioural
Study Participants will collect and use fruit and vegetable CSA boxes given to them weekly for 10 weeks.
Bikeshare PrescriptionBehavioural
Study participants will use bikeshare for transportation and physical activity for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Fruit and Vegetable CSA Prescription | Active comparator | 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. Receives: Behavioral: Fruit and Vegetable CSA Prescription |
| Bikeshare Prescription | Active comparator | 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. Receives: Behavioral: Bikeshare Prescription |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Between Baseline and Follow-Up visits for a total of 16-18 weeks
Secondary outcomes (3)
Fasting Lipid Panel
Fasting Lipid Panel will be collected at Baseline and at Follow-Up, which will be approximately a 12-16 week timeframe.
Measured: Baseline, 12 - 16 weeks
Glycated Hemoglobin (HgA1c)
Glycated Hemoglobin will be collected at Baseline and at Follow-Up, which will be approximately a 12-16 week timeframe.
Measured: Baseline, 12 -16 weeks
Blood Pressure
Blood Pressure will be taken at Baseline and at Follow-Up, which will be approximately a 12-16 week timeframe.
Measured: Baseline, 12 - 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2016
- Study completion24 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Bruce P Barrett, MD, PhD, Principal investigator, Professor, Clinician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870322
- Sponsor's protocol ID
- 2016-0372
- Other IDs
- 1K24AT006543-01
- Acronym
- FAVORx
- Status last verified
- Oct 2017
- First submitted
- 28 Jul 2016
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Feasibility of Fruit and Vegetable or Recreation Prescriptions Among UW-Madison Students
- ClinicalTrials.gov ID
- NCT02870322
- Acronym / sponsor ID
- FAVORx / 2016-0372
- Conditions
- Overweight, Obesity
- Keywords
- overweight, obesity, lifestyle prescription, prevention, physical activity, healthy eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- 24 Oct 2017 (actual)
- First posted
- 17 Aug 2016 (estimated)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fruit and Vegetable CSA Prescription | Active comparator | Behavioral: Fruit and Vegetable CSA PrescriptionStudy 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. |
| Bikeshare Prescription | Active comparator | Behavioral: Bikeshare PrescriptionStudy 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Fruit and Vegetable CSA PrescriptionStudy Participants will collect and use fruit and vegetable CSA boxes given to them weekly for 10 weeks. | Behavioural | Fruit and Vegetable CSA Prescription |
| Bikeshare PrescriptionStudy participants will use bikeshare for transportation and physical activity for 10 weeks | Behavioural | Bikeshare Prescription |
Primary outcome
Change in Body Mass Index
Time frame: Between Baseline and Follow-Up visits for a total of 16-18 weeks
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.
3 secondary outcomes
Fasting Lipid Panel
Time frame: Baseline, 12 - 16 weeks
Glycated Hemoglobin (HgA1c)
Time frame: Baseline, 12 -16 weeks
Blood Pressure
Time frame: Baseline, 12 - 16 weeks
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 26 Oct 2017.
- 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.
Bruce P Barrett, MD, PhD principal investigator
Professor, Clinician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fruit and Vegetable CSA Prescription and Bikeshare Prescription in people with Overweight and Obesity, run by University of Wisconsin, Madison 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 6 inclusion and 4 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 26 Oct 2017. 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 Body Mass Index (time frame: Between Baseline and Follow-Up visits for a total of 16-18 weeks). 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 26 Oct 2017.