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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Produce Prescription Dose Response: A Randomized Community Trial
Ryan M Kane1,2,3, Ximena Perez-Velazco4,5,6, Ronli Levi7,8
1Food is Medicine Institute, Friedman School of Nutrition Science and Policy, Tufts University, Boston, MA, USA.
Background:
Produce prescriptions (PRx) may improve diet quality and food security. However, there is little data to inform PRx dose recommendations.
Objective:
To identify how PRx dose affects benefit redemption, food security, and fruit/vegetable (FV) intake.
Design:
Three-arm, prospective randomized community trial.
Participants:
Adult clients of a community-based nonprofit social service provider.
Interventions:
Monthly electronic distribution of $40, $80, or $110 (equivalent to 10%, 20%, or 30% of the FV component of the USDA Thrifty Food Plan) for 6 months, redeemable at major grocery stores only for FV.
Main Measures:
Primary (benefit redemption) and secondary (food security and FV intake) outcomes were assessed at 3 months (primary endpoint) and 6 months.
Key Results:
Study participants (n = 242) were randomized to $40 (n = 81), $80 (n = 80), or $110 (n = 81) PRx arms. Mean (SD) age was 35.16 (9.45) years and 235 (97.1%) self-identified as female and 200 (82.6%) as Hispanic. Overall, there appeared to be a dose-response relationship with progressively greater benefit redemption rate, food security, and FV consumption as PRx dose increased. Compared with $40, the $110 PRx dose significantly improved food insecurity (p = 0.01) and FV intake (p = 0.03) at 3 months, and the benefit redemption rate (p = 0.04) at 6 months. At 3 months, the benefit redemption rate was 60.2% (95%CI 51.9-68.6%) $40 group, 67.6% (95%CI 59.9-75.3%) $80 group, and 70.4% (95%CI 63.0-77.9%) $110 group. Food insecurity was reported for 74.3% (95%CI 62.0-86.6%) $40 group, 66.2% (95%CI 50.1-82.2%) $80 group, and 47.4% (95%CI 31.6-63.1%) $110 group. Mean FV consumption in cups/day was 2.51 (95%CI 2.31-2.72) $40 group, 2.66 (95%CI 2.38-2.95) $80 group, and 2.89 (95%CI 2.61-3.17) $110 group.
Conclusions:
Higher PRx dose increased benefit redemption, food security, and FV consumption, especially when comparing the $110 and $40 doses. Dose is an important design element to improve PRx redemption levels and potentially PRx-related health outcomes.
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