Fresh Start: Increasing Early Produce Intake

NCT ID: NCT05153577

Last Updated: 2021-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-09

Study Completion Date

2021-11-10

Brief Summary

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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

Detailed Description

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Investigators are piloting a produce box delivery program to approximately 50 WIC-eligible, low-income families in West Philadelphia in partnership with the Farm to Families Initiative (St. Christopher's Foundation for Children) and Food Connect, a local food delivery program. Both partnerships have been previously established and are maintained through the Office of Community Relations. The program will be 8 weeks in duration; in the first 4 weeks, all families will receive a free, weekly produce box from Farm to Families. In the second two weeks, the 50 families will be randomized into two groups, each with 25 participants. One group will be asked to pay $5 for the produce box and the other group will pay $10, using food benefits or their own income. Recipes that include foods in the produce box will be included with the delivery along with children's activities (books, coloring pages, card games, etc.) related to fruits and vegetables. Participating parents will complete three online surveys throughout the program. These pre-, mid-, and post-intervention surveys will assess the effect of the program and participant satisfaction.

The expected goals are to:

1. Evaluate the effect of different pricing models on participation of low-income, WIC-eligible families in a produce delivery program
2. Evaluate the efficacy of a low-cost produce delivery program to increase perceived intake of produce among low-income young children.
3. Evaluate efficacy of a low-cost produce delivery program to increase perceived access to produce among low-income families in West Philadelphia.

Conditions

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Food Insecurity

Keywords

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WIC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Group A: Free produce box

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.

Group Type ACTIVE_COMPARATOR

Group A: $5 produce box

Intervention Type 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 B: Free produce box

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.

Group Type ACTIVE_COMPARATOR

Group B: $10 produce box

Intervention Type 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.

Interventions

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Group A: $5 produce box

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.

Intervention Type OTHER

Group B: $10 produce box

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Subjects must:

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

Exclusion Criteria

Subjects must not:

1. 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.)
2. 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Danielle Cullen, MD, MPH, MSHP

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 25102415 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25091630 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21999291 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26498462 (View on PubMed)

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/

Reference Type BACKGROUND
PMID: 28605175 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11271692 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17964309 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33487590 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29061141 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12725713 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25066057 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 20595453 (View on PubMed)

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 Jul 9;25(8):102884. doi: 10.1016/j.acap.2025.102884. Online ahead of print.

Reference Type DERIVED
PMID: 40645578 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://epi.grants.cancer.gov/diet/usualintakes/national-data-usual-dietary-intakes-2007-to-2010.pdf

National Cancer Institute. Usual Dietary Intakes: Food Intakes, U.S. Population, 2007-10.

http://www.ers.usda.gov/publications/pub-details/?pubid=99281

Coleman-Jensen A, Rabbitt MP, Gregory CA, Singh A. Household Food Security in the United States in 2019.

https://map.feedingamerica.org/county/2018/child/pennsylvania/county/philadelphia/

Feeding America. Map the Meal Gap. Child Food Insecurity in Philadelphia County. Accessed February 20, 2021.

https://www.fns.usda.gov/fmnp/wic-farmers-market-nutrition-program

US Department of Agriculture, Food and Nutrition Service. WIC FMNP FY 2018 FNS-203 Report.

Other Identifiers

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21-018757

Identifier Type: -

Identifier Source: org_study_id