Fruit and Vegetable Prescription Program
FVRx
1 other identifier
interventional
58
1 country
1
Brief Summary
The purpose of this study is to determine the effectiveness of a worksite based Fruit \& Vegetable Prescription (Rx) Program designed to increase fruit and vegetable consumption and improve diet quality and other health outcomes of participants. The program includes incentives (coupons) and skill building/educational sessions to increase intake of fruits, vegetables, and other health promoting foods (i.e. legumes, whole grains). The program will focus on delicious, nutritious, affordable, simple and quick meal preparation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Apr 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 20, 2017
CompletedFirst Submitted
Initial submission to the registry
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedMarch 30, 2020
March 1, 2020
1.8 years
November 1, 2017
March 26, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Diet quality
Participants will complete three 24-hour recalls using the web-based ASA24 - http://riskfactor.cancer.gov/tools/instruments/asa24/ (Automated Self-Administered 24-Hour Recall) at each of the 3 assessment time points (9 total). Diet quality will be assessed using the Healthy Eating Index 2010. The Prevention Research Center will have computers available for participants who do not have access to computers to complete the ASA24.
Up to 3 Months
Secondary Outcomes (7)
Change in Household meal practices
Up to 3 Months
Change in Body Mass Index (BMI)
Up to 3 Months
Change in Body Composition- Body Fat and Body Water Percentage
Up to 3 Months
Change in Waist circumference
Up to 3 Months
Change in Serum Lipids and HbA1c
Up to 3 Months
- +2 more secondary outcomes
Other Outcomes (4)
Change in Physical Activity
Up to 3 Months
Change in Cooking Skills
Up to 3 Months
Compliance
One week
- +1 more other outcomes
Study Arms (2)
Intervention Group
ACTIVE COMPARATORThe cooking skill building/nutrition education workshops will be led by a multidisciplinary team comprised of: a chef/instructor, a nutritionist and/or registered dietitian, MD and/or Preventive Medicine Resident, and Yale-Griffin Prevention Research Center staff. The cooking/nutrition education workshop sessions will be approximately 45 minutes and will: include a plant forward approach to healthy eating; integrate nutrition and health-related information and cooking instruction (i.e. knife skills, equipment use); show participants how to prepare meals that are simple, nutritious, affordable, and delicious; provide recipes and nutrition information aimed at improving dietary intake and health status; and provide an enjoyable program that participants will look forward to attending. Fruit and vegetable prescription vouchers will be redeemed at ShopRite grocery stores (Ansonia and Shelton locations) and Griffin Hospital's farmers market, where redemption will be tracked.
Control Group
PLACEBO COMPARATORThe control group will not receive vouchers or nutrition education/skill building but will be exposed to any standard Griffin Hospital worksite offerings. A "mini program" (2 -4 hours) workshop will be offered to participants in the control group, and all intervention materials will be provided.
Interventions
Session One: Loving Food That Loves You Back - Food as Fuel * connection nutrition and health Session Two: Myth busting: Fruits and Vegetables - delicious and affordable * seasonal fruits \& vegetables in the diet Session Three: No Time to Cook! Making nutritious meals that are fast and easy * quickly make delicious/nutritious meals using minimal ingredients Session Four: Don't Eat Food You Can't Pronounce Except Quinoa; Eat Quinoa * choose healthier foods Session Five: Taste Bud Rehab * reduce foods high in sugar and salt.Mind-body connection Session Six: Batch \& One Ingredient Cooking * making large quantities to freeze; one ingredient cooking Session Seven: Sweet Tooth? Healthy Desserts * prepare healthier desserts Session Eight: Family Meal Practices * healthy eating habits in children Session Nine: Snacks as Mini Meals * make nutritious snacks to keep energy up all day Session Ten: Revamp Your Favorite Recipe * "healthy up" favorite recipes
The control group will not receive vouchers or nutrition education/skill building but will be exposed to any standard Griffin Hospital worksite offerings. A "mini program" (2 -4 hours) workshop will be offered to participants in the control group, and all intervention materials will be provided.
Eligibility Criteria
You may qualify if:
- Griffin employees, aged 18 and over, with a child/children enrolled in VITAHLS schools (Shelton, Ansonia, Derby, Seymour, and Naugatuck) - grades pre-k thru 12.
- be able to attend weekly 45 minutes nutrition/cooking workshops.
You may not qualify if:
- Inability to attend majority of the Nutrition and cooking workshops
- Anticipated inability to complete study protocol for any reason
- Diagnosis of cancer except skin cancer of less than 5 years or unstable treatment for less than 5 years.
- Unstable angina or other significant cardiovascular condition, prior or planned bariatric surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BETH COMERFORDlead
Study Sites (1)
Griffin Hospital
Derby, Connecticut, 06418, United States
Related Publications (15)
Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
PMID: 24570244BACKGROUNDGuenther PM, Dodd KW, Reedy J, Krebs-Smith SM. Most Americans eat much less than recommended amounts of fruits and vegetables. J Am Diet Assoc. 2006 Sep;106(9):1371-9. doi: 10.1016/j.jada.2006.06.002.
PMID: 16963342BACKGROUNDBenton D. Role of parents in the determination of the food preferences of children and the development of obesity. Int J Obes Relat Metab Disord. 2004 Jul;28(7):858-69. doi: 10.1038/sj.ijo.0802532.
PMID: 15170463BACKGROUNDBirch LL, Anzman-Frasca S. Learning to prefer the familiar in obesogenic environments. Nestle Nutr Workshop Ser Pediatr Program. 2011;68:187-96; discussion 196-9. doi: 10.1159/000325856. Epub 2011 Oct 3.
PMID: 22044900BACKGROUNDFuemmeler BF, Anderson CB, Masse LC. Parent-child relationship of directly measured physical activity. Int J Behav Nutr Phys Act. 2011 Mar 8;8:17. doi: 10.1186/1479-5868-8-17.
PMID: 21385455BACKGROUNDSoler RE, Leeks KD, Razi S, Hopkins DP, Griffith M, Aten A, Chattopadhyay SK, Smith SC, Habarta N, Goetzel RZ, Pronk NP, Richling DE, Bauer DR, Buchanan LR, Florence CS, Koonin L, MacLean D, Rosenthal A, Matson Koffman D, Grizzell JV, Walker AM; Task Force on Community Preventive Services. A systematic review of selected interventions for worksite health promotion. The assessment of health risks with feedback. Am J Prev Med. 2010 Feb;38(2 Suppl):S237-62. doi: 10.1016/j.amepre.2009.10.030.
PMID: 20117610BACKGROUNDKatz DL, O'Connell M, Yeh MC, Nawaz H, Njike V, Anderson LM, Cory S, Dietz W; Task Force on Community Preventive Services. Public health strategies for preventing and controlling overweight and obesity in school and worksite settings: a report on recommendations of the Task Force on Community Preventive Services. MMWR Recomm Rep. 2005 Oct 7;54(RR-10):1-12.
PMID: 16261131BACKGROUNDChapman LS. Meta-evaluation of worksite health promotion economic return studies: 2012 update. Am J Health Promot. 2012 Mar-Apr;26(4):TAHP1-TAHP12. doi: 10.4278/ajhp.26.4.tahp. No abstract available.
PMID: 22375583BACKGROUNDBeresford SA, Thompson B, Feng Z, Christianson A, McLerran D, Patrick DL. Seattle 5 a Day worksite program to increase fruit and vegetable consumption. Prev Med. 2001 Mar;32(3):230-8. doi: 10.1006/pmed.2000.0806.
PMID: 11277680BACKGROUNDSorensen G, Stoddard A, Peterson K, Cohen N, Hunt MK, Stein E, Palombo R, Lederman R. Increasing fruit and vegetable consumption through worksites and families in the treatwell 5-a-day study. Am J Public Health. 1999 Jan;89(1):54-60. doi: 10.2105/ajph.89.1.54.
PMID: 9987465BACKGROUNDAn R. Effectiveness of subsidies in promoting healthy food purchases and consumption: a review of field experiments. Public Health Nutr. 2013 Jul;16(7):1215-28. doi: 10.1017/S1368980012004715. Epub 2012 Nov 5.
PMID: 23122423BACKGROUNDBall K, McNaughton SA, Le HN, Gold L, Ni Mhurchu C, Abbott G, Pollard C, Crawford D. Influence of price discounts and skill-building strategies on purchase and consumption of healthy food and beverages: outcomes of the Supermarket Healthy Eating for Life randomized controlled trial. Am J Clin Nutr. 2015 May;101(5):1055-64. doi: 10.3945/ajcn.114.096735. Epub 2015 Apr 15.
PMID: 25877492BACKGROUNDMarshall A, et al. Assessment of health-related physical activity: Results of the International Physical Activity Questionnaire Reliability and Validity Study.
BACKGROUNDCarpenter RA, Finley C, Barlow CE. Pilot test of a behavioral skill building intervention to improve overall diet quality. J Nutr Educ Behav. 2004 Jan-Feb;36(1):20-4. doi: 10.1016/s1499-4046(06)60124-3.
PMID: 14756978BACKGROUNDJekel J, Katz D, Elmore J. Epidemiology, Biostatistics and Preventive Medicine. 2nd ed. Philadelphia, PA: WB Saunders Company; 2001
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beth P Comerford, MS
Yale-Griffin Prevention Research Center
- STUDY CHAIR
Kimberly Doughty, PhD, MPH
Yale-Griffin Prevention Research Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PRINCIPAL INVESTIGATOR
Study Record Dates
First Submitted
November 1, 2017
First Posted
August 28, 2019
Study Start
April 20, 2017
Primary Completion
January 31, 2019
Study Completion
January 31, 2019
Last Updated
March 30, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share