Fruit And Vegetable Or Recreation Prescriptions for UW-Madison Students

NCT02870322 | Completed

• 2 other identifiers: 2016-03721K24AT006543-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Overweight; Obesity

Keywords

overweight; obesity; lifestyle prescription; prevention; physical activity; healthy eating

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Fasting Lipid Panel

  Baseline, 12 - 16 weeks

• Glycated Hemoglobin (HgA1c)

  Baseline, 12 -16 weeks

• Blood Pressure

  Baseline, 12 - 16 weeks

Study Arms (3)

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.

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.

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.

Interventions

Fruit and Vegetable CSA Prescription BEHAVIORAL

Study Participants will collect and use fruit and vegetable CSA boxes given to them weekly for 10 weeks.

Fruit and Vegetable CSA Prescription

Bikeshare Prescription BEHAVIORAL

Study participants will use bikeshare for transportation and physical activity for 10 weeks

Bikeshare Prescription

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institutes of Health (NIH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity

Interventions

Fruit

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Bruce P Barrett, MD, PhD

  Professor, Clinician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 17, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: October 24, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)