Restricted accessResearch articleFirst published online 2026-1
Implementation and Effectiveness Outcomes of a Pilot Comparative Effectiveness Randomized Controlled Trial Evaluating a Food Is Medicine Program Among At-Risk Pediatric Populations
Food Is Medicine (FIM) programs have demonstrated effectiveness in improving diet quality and food insecurity. There remains a lack of evidence of their impacts in pediatric populations. This pilot comparative effectiveness randomized control trial assessed two FIM strategies on implementation and health outcomes in Medicaid-eligible children aged 5–12 years with a BMI ≥85th percentile.
Methods:
Participants (n = 150) were enrolled for a 32-week intervention through recruitment at two urban pediatric primary care clinics in Houston, TX. Participants were randomized 1:1:1 into three arms: (1) biweekly $25 produce vouchers + nutrition education, (2) biweekly produce home delivery + nutrition education, or (3) wait-listed control (n = 50 per arm). Implementation outcomes included retention, redemption, dosage, reach, fidelity, and acceptability. Child outcome measures included diet, food security, BMI z-scores, hemoglobin A1c, liver panels, and lipid panels. Multilevel mixed-effects regression models were used to assess the effectiveness of the intervention on outcomes.
Results:
On average, voucher participants redeemed $353 out of $400 (88%) of their funds, and 100% of the home delivery group received ∼18 lb (52 servings) of produce per week. Parents found the program helpful in reducing grocery costs (voucher: 95%, delivery: 76%). Compared to the control group, voucher group participants had a significant decrease in aspartate aminotransferase (−5.50, 95% confidence interval: −9.43, −1.57, p = 0.006) from baseline to post-intervention.
Conclusions:
This pilot study found FIM programs are both feasible and well accepted among at-risk populations, with slightly higher acceptability of the voucher model. More adequately powered studies with a stringent design are needed to test their effectiveness.
BhatS, CoyleDH, TrieuK, et al.Healthy food prescription programs and their impact on dietary behavior and cardiometabolic risk factors: A systematic review and meta-analysis. Adv Nutr, 2021; 12(5):1944–1956; doi: 10.1093/ADVANCES/NMAB039
2.
DownerS, ClippingerE, KummerC, et al.Food is medicine research action plan. 2022.
3.
LittleM, RosaE, HeasleyC, et al.Promoting healthy food access and nutrition in primary care: A systematic scoping review of food prescription programs. Am J Health Promot, 2022; 36(3):518–536; doi: 10.1177/08901171211056584
4.
CookM, WardR, NewmanT, et al.Food security and clinical outcomes of the 2017 Georgia fruit and vegetable prescription program. J Nutr Educ Behav, 2021; 53(9):770–778; doi: 10.1016/J.JNEB.2021.06.010
5.
Saxe-CustackA, LachanceJ, JessJ, et al.Influence of a pediatric fruit and vegetable prescription program on child dietary patterns and food security. Nutrients, 2021; 13(8):2619; doi: 10.3390/NU13082619
6.
CaferA, RosenthalM, SmithP, et al.Examining the context, logistics, and outcomes of food prescription programs: A scoping review. Res Social Adm Pharm, 2023; 19(1):57–68; doi: 10.1016/J.SAPHARM.2022.09.007
7.
HagerK, MozaffarianD. The promise and uncertainty of fruit and vegetable prescriptions in health care. J Nutr, 2020; 150(11):2846–2848; doi: 10.1093/jn/nxaa283
8.
VolppKG, BerkowitzSA, SharmaSV, et al.; American Heart Association. Food is medicine: A presidential advisory from the American Heart Association. Circulation, 2023; 148(18):1417–1439; doi: 10.1161/CIR.0000000000001182/ASSET/4825DE2F-0E0D-4FAE-953D-567142C36989/ASSETS/GRAPHIC/CIR.0000000000001182.FIG06.JPG
9.
MozaffarianD, BlanckHM, GarfieldKM, et al.A Food is Medicine approach to achieve nutrition security and improve health. Nat Med, 2022; 28(11):2238–2240; doi: 10.1038/S41591-022-02027-3
10.
Caulfield LE, Bennett WL, Gross SM, et al. Maternal and child outcomes associated with the Special Supplemental Nutrition program for Women, Infants, and Children (WIC) [Internet]. AHRQ Comparative Effectiveness Reviews 2022; Report No.: 22-EHC019; doi: 10.23970/AHRQEPCCER253
11.
CavanaghM, JurkowskiJ, BozlakC, et al.Veggie Rx: An outcome evaluation of a healthy food incentive programme. Public Health Nutr, 2017; 20(14):2636–2641; doi: 10.1017/S1368980016002081
12.
StotzSA, Budd NugentN, RidbergR, et al.Produce prescription projects: Challenges, solutions, and emerging best practices—Perspectives from health care providers. Prev Med Rep, 2022; 29:101951; doi: 10.1016/J.PMEDR.2022.101951
13.
MathurM, MarshallA, YeragiP, et al.Design and protocol of a clinic-based comparative effectiveness randomized controlled trial to determine the feasibility and effectiveness of food prescription program strategies in at-risk pediatric populations. Contemp Clin Trials, 2023; 135:107379; doi: 10.1016/j.cct.2023.107379
SanyaoluA, OkorieC, QiX, et al.Childhood and adolescent obesity in the United States: A public health concern. Glob Pediatr Health, 2019; 6:2333794X19891305; doi: 10.1177/2333794X19891305
16.
StiermanB, AffulJ, CarrollMD, et al.National Health and Nutrition Examination Survey 2017–March 2020 prepandemic data files development of files and prevalence estimates for selected health outcomes. Natl Health Stat Report, 2021; 2021(158); doi: 10.15620/CDC:106273
17.
PereiraAR, OliveiraA. Dietary interventions to prevent childhood obesity: A literature review. Nutrients, 2021; 13(10):3447; doi: 10.3390/NU13103447
18.
RoblinL. Childhood obesity: Food, nutrient, and eating-habit trends and influences. Appl Physiol Nutr Metab, 2007; 32(4):635–645; doi: 10.1139/H07-046
19.
PetersenKS, Kris-EthertonPM. Diet quality assessment and the relationship between diet quality and cardiovascular disease risk. Nutrients, 2021; 13(12):4305; doi: 10.3390/NU13124305
BlanchetteL, BrugJ. Determinants of fruit and vegetable consumption among 6-12-year-old children and effective interventions to increase consumption. J Hum Nutr Diet, 2005; 18(6):431–443; doi: 10.1111/J.1365-277X.2005.00648.X
22.
KrølnerR, RasmussenM, BrugJ, et al.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; 8:112; doi: 10.1186/1479-5868-8-112
23.
FahlmanMM, McCaughtryN, MartinJ, et al.Racial and socioeconomic disparities in nutrition behaviors: Targeted interventions needed. J Nutr Educ Behav, 2010; 42(1):10–16; doi: 10.1016/J.JNEB.2008.11.003
24.
AiyerJN, RaberM, BelloRS, et al.A pilot food prescription program promotes produce intake and decreases food insecurity. Transl Behav Med, 2019; 9(5):922–930; doi: 10.1093/TBM/IBZ112
25.
OliveiraJB, ToL, De La CruzY, et al.Prompting a fresh start for adults with food insecurity and increased BMI: A case series of four patients in a food prescription program. Cureus, 2021; 13(3):e13857; doi: 10.7759/CUREUS.13857
26.
HaslamA, GillJ, TaniguchiT, et al.The effect of food prescription programs on chronic disease management in primarily low-income populations: A systematic review and meta-analysis. Nutr Health, 2022; 28(3):389–400; doi: 10.1177/02601060211070718
27.
SharmaSV, MarkhamC, ChowJ, et al.Evaluating a school-based fruit and vegetable co-op in low-income children: A quasi-experimental study. Prev Med, 2016; 91:8–17; doi: 10.1016/J.YPMED.2016.07.022
28.
MarshallAN, ChuangRJ, ChowJ, et al.Food insecurity among low-income households with children participating in a school-based fruit and vegetable co-op. Children (Basel), 2022; 9(8):1250; doi: 10.3390/CHILDREN9081250
29.
MarshallAN, MarkhamC, RanjitN, et al.Long-term impact of a school-based nutrition intervention on home nutrition environment and family fruit and vegetable intake: A two-year follow-up study. Prev Med Rep, 2020; 20:101247; doi: 10.1016/J.PMEDR.2020.101247
HamplSE, HassinkSG, SkinnerAC, et al.Clinical practice guideline for the evaluation and treatment of children and adolescents with obesity. American Academy of Pediatrics (AAP), 2023; 151(2):e2022060640; doi: 10.1542/PEDS.2022-060640
ThompsonFE, SubarAF, SmithAF, et al.Fruit and vegetable assessment: Performance of 2 new short instruments and a food frequency questionnaire. J Am Diet Assoc, 2002; 102(12):1764–1772; doi: 10.1016/S0002-8223(02)90379-2
36.
HoelscherDM, DayRS, KelderSH, et al.Reproducibility and validity of the secondary level School-Based Nutrition Monitoring student questionnaire. J Am Diet Assoc, 2003; 103(2):186–194; doi: 10.1053/jada.2003.50031
37.
HagerER, QuiggAM, BlackMM, et al.Development and validity of a 2-item screen to identify families at risk for food insecurity. Pediatrics, 2010; 126(1):e26–e32; doi: 10.1542/PEDS.2009-3146
38.
CallowayEE, CarpenterLR, GarganoT, et al.Development of new measures to assess household nutrition security, and choice in dietary characteristics. Appetite, 2022; 179:106288; doi: 10.1016/J.APPET.2022.106288
39.
Stata Corp. Stata | StataCorp LLC. 2019. Available from: https://www.stata.com/company/ [Last accessed: October5, 2021].
40.
XieJ, PriceA, CurranN, et al.The impact of a produce prescription programme on healthy food purchasing and diabetes-related health outcomes. Public Health Nutr, 2021; 24(12):3945–3955; doi: 10.1017/S1368980021001828
41.
BuscailC, MargatA, PetitS, et al.Fruits and vegetables at home (FLAM): A randomized controlled trial of the impact of fruits and vegetables vouchers in children from low-income families in an urban district of France. BMC Public Health, 2018; 18(1):1065; doi: 10.1186/S12889-018-5908-5
42.
BryceR, WolfsonBryceJA, CohenBryceA, et al.A pilot randomized controlled trial of a fruit and vegetable prescription program at a federally qualified health center in low income uncontrolled diabetics. Prev Med Rep, 2021; 23:101410; doi: 10.1016/J.PMEDR.2021.101410
43.
CaraballoG, MuletaH, ParmarA, et al.Qualitative analysis of a home-delivered produce prescription intervention to improve food and nutrition security. Nutrients, 2024; 16(23):4010; doi: 10.3390/NU16234010/S1
44.
FeldsteinAE, Patton-KuD, BoutelleKN. Obesity, nutrition and liver disease in children. Clin Liver Dis, 2014; 18(1):219–231; doi: 10.1016/J.CLD.2013.09.003
MuletaH, FischerLK, ChangM, et al.Pediatric produce prescription initiatives in the U.S.: A scoping review. Pediatr Res, 2024; 95(5):1193–1206; doi: 10.1038/S41390-023-02920-8
AuvinenA, SimockM, MoranA. Integrating produce prescriptions into the Healthcare System: Perspectives from key stakeholders. Int J Environ Res Public Health, 2022; 19(17):11010; doi: 10.3390/IJERPH191711010
50.
TeresiJA, YuX, StewartAL, et al.Guidelines for designing and evaluating feasibility pilot studies. Med Care, 2022; 60(1):95–103; doi: 10.1097/MLR.0000000000001664
51.
WhiteheadAL, JuliousSA, CooperCL, et al.Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res, 2016; 25(3):1057–1073; doi: 10.1177/0962280215588241
