Obesity Clinical Trial
— FAVORxOfficial title:
Measuring the Feasibility of Fruit and Vegetable or Recreation Prescriptions Among UW-Madison Students
Verified date | October 2017 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 25 |
Est. completion date | October 24, 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 24 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin - Madison | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Between Baseline and Follow-Up visits for a total of 16-18 weeks | |
Secondary | Fasting Lipid Panel | Fasting Lipid Panel will be collected at Baseline and at Follow-Up, which will be approximately a 12-16 week timeframe. | Baseline, 12 - 16 weeks | |
Secondary | Glycated Hemoglobin (HgA1c) | Glycated Hemoglobin will be collected at Baseline and at Follow-Up, which will be approximately a 12-16 week timeframe. | Baseline, 12 -16 weeks | |
Secondary | Blood Pressure | Blood Pressure will be taken at Baseline and at Follow-Up, which will be approximately a 12-16 week timeframe. | Baseline, 12 - 16 weeks |
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