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NCT04421755
The Produce Drop: Using Food as Medicine to Lower A1C Levels and Blood Pressure
NA trial testing Produce delivery in Diabetes in 85 participants. Completed in 16 March 2021.
16 March 2021
Quick facts
| Lead sponsor | University of Oklahoma |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 85 |
| Start date | 16 July 2019 |
| Primary completion | 16 March 2021 |
| Estimated completion | 16 March 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Produce delivery
- Cooking classes
Conditions studied
- Diabetes — all drugs for Diabetes →
- Hypertension — all drugs for Hypertension →
- Nutrition Poor — all drugs for Nutrition Poor →
Sponsor
University of Oklahoma
Who can join
Adults 18 to 64, any sex, with Diabetes or Hypertension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Hypertension and diabetes, which are increasing in prevalence, contribute to significant morbidity and mortality in the U.S. Self-management of these diseases, including adherence to dietary guidelines such as daily fruit and vegetable intake, can improve outcomes, but low-income patients encounter many barriers to adherence, such as food insecurity and poor nutrition literacy. Few clinicians screen for food insecurity, and even when screening is performed, there are few tested clinical response models. This study will evaluate the benefits of fresh fruit and vegetable home delivery program, without and with small-group culinary medicine cooking classes, on blood pressure and glucose control among patients accessing care at the University of Oklahoma Internal Medicine Clinic in Tulsa, OK. The Produce Drop pilot study will evaluate the feasibility and potential health benefits of a clinic-community partnership between OU Internal Medicine and a fresh produce home-delivery service provider, to promote adherence to F/V dietary guidelines among patients with suboptimal blood pressure and blood glucose control. Among half of those assigned to receive food assistance, we will evaluate the additional benefits of participation in 3-session, small-group, hands-on culinary medicine curriculum.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04421755
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04421755 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Oklahoma
- Last refreshed: 10 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04421755.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing