NCT04072757

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

1.8 years

First QC Date

November 1, 2017

Last Update Submit

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 COMPARATOR

The 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.

Behavioral: Intervention Group

Control Group

PLACEBO COMPARATOR

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.

Behavioral: Control Group

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

Intervention Group
Control GroupBEHAVIORAL

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.

Control Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Study Sites (1)

Griffin Hospital

Derby, Connecticut, 06418, United States

Location

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: 24570244BACKGROUND
  • Guenther 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: 16963342BACKGROUND
  • Benton 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: 15170463BACKGROUND
  • Birch 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: 22044900BACKGROUND
  • Fuemmeler 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: 21385455BACKGROUND
  • Soler 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: 20117610BACKGROUND
  • Katz 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: 16261131BACKGROUND
  • Chapman 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: 22375583BACKGROUND
  • Beresford 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: 11277680BACKGROUND
  • Sorensen 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: 9987465BACKGROUND
  • An 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: 23122423BACKGROUND
  • Ball 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: 25877492BACKGROUND
  • Marshall A, et al. Assessment of health-related physical activity: Results of the International Physical Activity Questionnaire Reliability and Validity Study.

    BACKGROUND
  • Carpenter 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: 14756978BACKGROUND
  • Jekel J, Katz D, Elmore J. Epidemiology, Biostatistics and Preventive Medicine. 2nd ed. Philadelphia, PA: WB Saunders Company; 2001

    BACKGROUND

Related Links

MeSH Terms

Conditions

Obesity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Beth P Comerford, MS

    Yale-Griffin Prevention Research Center

    PRINCIPAL INVESTIGATOR
  • Kimberly Doughty, PhD, MPH

    Yale-Griffin Prevention Research Center

    STUDY CHAIR

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

Locations