Fresh Start: Increasing Early Produce Intake

NCT05153577 | Completed

• 1 other identifier: 21-018757
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Nearly 22% of children in Philadelphia live in food-insecure (FI) households, often leading to reliance on inexpensive, nutrient-poor foods and associated poor health outcomes. Despite this, utilization of food benefit programs is often low, including the Special Supplemental Nutrition Program Women, Infants, and Children (WIC) Farmer's Market Nutrition Program (FMNP). In the prior qualitative study, Investigators found that parents desire to increase their children's intake of produce but face many barriers to produce access; caregivers described a preference for delivery-based, low-or-no cost food programs to increase produce access and intake among children. This pilot trial seeks to assess the effectiveness of a short-term, tiered-fee produce delivery program in retaining participants and increasing produce access and intake among families with WIC-eligible children

Conditions

Food Insecurity

Keywords

WIC

Outcome Measures

Primary Outcomes (1)

• Number of participants in both groups who continue to participate in the program weekly in different pricing models

  Participant ordering in each group will be tracked weekly in RedCap for week 1, 2, 3, 4, 5, 6, 7, and 8.

  8 weeks

Secondary Outcomes (7)

• Evaluate the impact of the produce delivery program on perceived intake and enjoyment of fruits and vegetables

  Up to 6 months

• Assess the efficacy of the produce delivery program in improving perceived diet

  Up to 6 months

• Evaluate the efficacy of the produce delivery program in improving perceived produce access, including attainability and cost, among the study population

  Up to 6 months

• Assess self-efficacy among the study population in regards to preparing home-cooked meals, particularly with fruits and vegetables.

  Up to 6 months

• Evaluate for changes in reported food insecurity among the stated study population.

  Up to 6 months

Study Arms (2)

Group A: Free produce box

ACTIVE COMPARATOR

Participants receive free weekly produce boxes for the first 4 weeks of the study and are then randomized to pay $5 per box (with continued free weekly delivery) for the remaining 4 weeks of the study.

Other: Group A: $5 produce box

Group B: Free produce box

ACTIVE COMPARATOR

Participants receive free weekly produce boxes for the first 4 weeks of the study and are then randomized to pay $10 per box (with continued free weekly delivery) for the remaining 4 weeks of the study.

Other: Group B: $10 produce box

Interventions

Group A: $5 produce box OTHER

Participants receive free weekly produce boxes delivered to their home for the first 4 weeks of the study and are then randomized to pay $5 per box (with continued free weekly delivery) for the remaining 4 weeks of the study. Participants also complete survey at the beginning, middle, and end of the produce delivery program.

Group A: Free produce box

Group B: $10 produce box OTHER

Participants receive free weekly produce boxes delivered to their home for the first 4 weeks of the study and are then randomized to pay $10 per box (with continued free weekly delivery) for the remaining 4 weeks of the study. Participants also complete survey at the beginning, middle, and end of the produce delivery program.

Group B: Free produce box

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must:
• Be over 18 years of age
• Be the parent or guardian for children ages 0 to 5 years of age who receive or are eligible to receive WIC benefits
• Be the parent or guardian for children ages 0 to 5 years of age who receive pediatric care at CHOP Primary Care - Cobbs Creek
• Live or have access to an address where packages can be delivered
• Have access to an electronic device and internet in order to access the online produce box ordering portal
• Be willing to complete three 10-15 minute surveys throughout the intervention either online or via telephone
• Consent to have their contact information shared with Farm to Families and Food Connect

You may not qualify if:

• Subjects must not:
• Be participating in another intervention which provides produce just prior to or simultaneous with participation in this study (e.g. Farm Food Box Program, etc.)
• Be subjects who, in the opinion of the Investigator(s), may be non-compliant with study schedules or procedures Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations of these criteria must be reported in accordance with IRB Policies and Procedures.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• University of Pennsylvania: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

Related Publications (14)

• Kim SA, Moore LV, Galuska D, Wright AP, Harris D, Grummer-Strawn LM, Merlo CL, Nihiser AJ, Rhodes DG; Division of Nutrition, Physical Activity, and Obesity, National Center for Chronic Disease Prevention and Health Promotion, CDC. Vital signs: fruit and vegetable intake among children - United States, 2003-2010. MMWR Morb Mortal Wkly Rep. 2014 Aug 8;63(31):671-6.

  PMID: 25102415 BACKGROUND

• Di Noia J, Byrd-Bredbenner C. Determinants of fruit and vegetable intake in low-income children and adolescents. Nutr Rev. 2014 Sep;72(9):575-90. doi: 10.1111/nure.12126. Epub 2014 Aug 4.

  PMID: 25091630 BACKGROUND

• Krolner R, Rasmussen M, Brug J, Klepp KI, Wind M, Due P. Determinants of fruit and vegetable consumption among children and adolescents: a review of the literature. Part II: qualitative studies. Int J Behav Nutr Phys Act. 2011 Oct 14;8:112. doi: 10.1186/1479-5868-8-112.

  PMID: 21999291 BACKGROUND

• COUNCIL ON COMMUNITY PEDIATRICS; COMMITTEE ON NUTRITION. Promoting Food Security for All Children. Pediatrics. 2015 Nov;136(5):e1431-8. doi: 10.1542/peds.2015-3301.

  PMID: 26498462 BACKGROUND

• National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Food and Nutrition Board; Committee to Review WIC Food Packages. Review of WIC Food Packages: Improving Balance and Choice: Final Report. Washington (DC): National Academies Press (US); 2017 May 1. Available from http://www.ncbi.nlm.nih.gov/books/NBK435902/

  PMID: 28605175 BACKGROUND

• Anderson JV, Bybee DI, Brown RM, McLean DF, Garcia EM, Breer ML, Schillo BA. 5 a day fruit and vegetable intervention improves consumption in a low income population. J Am Diet Assoc. 2001 Feb;101(2):195-202. doi: 10.1016/S0002-8223(01)00052-9.

  PMID: 11271692 BACKGROUND

• Kropf ML, Holben DH, Holcomb JP Jr, Anderson H. Food security status and produce intake and behaviors of Special Supplemental Nutrition Program for Women, Infants, and Children and Farmers' Market Nutrition Program participants. J Am Diet Assoc. 2007 Nov;107(11):1903-8. doi: 10.1016/j.jada.2007.08.014.

  PMID: 17964309 BACKGROUND

• Di Noia J, Monica D, Sikorskii A, Nelson J. Pilot Study of a Farm-to-Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Intervention Promoting Vegetable Consumption. J Acad Nutr Diet. 2021 Oct;121(10):2035-2045. doi: 10.1016/j.jand.2020.12.020. Epub 2021 Jan 22.

  PMID: 33487590 BACKGROUND

• Lagisetty P, Flamm L, Rak S, Landgraf J, Heisler M, Forman J. A multi-stakeholder evaluation of the Baltimore City virtual supermarket program. BMC Public Health. 2017 Oct 23;17(1):837. doi: 10.1186/s12889-017-4864-9.

  PMID: 29061141 BACKGROUND

• Townsend MS, Kaiser LL, Allen LH, Joy AB, Murphy SP. Selecting items for a food behavior checklist for a limited-resource audience. J Nutr Educ Behav. 2003 Mar-Apr;35(2):69-77. doi: 10.1016/s1499-4046(06)60043-2.

  PMID: 12725713 BACKGROUND

• Couch SC, Glanz K, Zhou C, Sallis JF, Saelens BE. Home food environment in relation to children's diet quality and weight status. J Acad Nutr Diet. 2014 Oct;114(10):1569-1579.e1. doi: 10.1016/j.jand.2014.05.015. Epub 2014 Jul 23.

  PMID: 25066057 BACKGROUND

• Lahne J, Wolfson JA, Trubek A. Development of the Cooking and Food Provisioning Action Scale (CAFPAS): A new measurement tool for individual cooking practice. Food Qual Prefer. 2017;62(July):96-105. doi:10.1016/j.foodqual.2017.06.022

  BACKGROUND

• Hager ER, Quigg AM, Black MM, Coleman SM, Heeren T, Rose-Jacobs R, Cook JT, Ettinger de Cuba SA, Casey PH, Chilton M, Cutts DB, Meyers AF, Frank DA. Development and validity of a 2-item screen to identify families at risk for food insecurity. Pediatrics. 2010 Jul;126(1):e26-32. doi: 10.1542/peds.2009-3146.

  PMID: 20595453 BACKGROUND

• Joshi P, Van Remortel BJ, Rameswaran J, Cullen DL. Effect of Price on Women, Infants, and Children-Eligible Caregiver Participation in a Produce Program: A Randomized Trial. Acad Pediatr. 2025 Nov-Dec;25(8):102884. doi: 10.1016/j.acap.2025.102884. Epub 2025 Jul 9.

  PMID: 40645578 DERIVED

Related Links

• National Cancer Institute. Usual Dietary Intakes: Food Intakes, U.S. Population, 2007-10.
• Coleman-Jensen A, Rabbitt MP, Gregory CA, Singh A. Household Food Security in the United States in 2019.
• Feeding America. Map the Meal Gap. Child Food Insecurity in Philadelphia County. Accessed February 20, 2021.
• US Department of Agriculture, Food and Nutrition Service. WIC FMNP FY 2018 FNS-203 Report.

Study Officials

• Danielle Cullen, MD, MPH, MSHP

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Potential subjects will initially be recruited from a list of 30 parents who participated in the previous IRB-exempt, qualitative study (IRB 20-017497 - Fresh Start) and consented to be re-contacted for future studies. The remaining subjects will be recruited from a list of families who received a WIC prescription for their child(ren) from a provider at the Children's Hospital of Philadelphia (CHOP) Cobbs Creek between 2019-2020; this list was obtained via IT query of Epic for our prior study. No medical records will be accessed for screening for this study. Potential subjects will be screened using the protocol inclusion and exclusion criteria during the initial recruitment call.

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 10, 2021
• Study Start: June 9, 2021
• Primary Completion: September 23, 2021
• Study Completion: November 10, 2021
• Last Updated: December 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)