Evidence map›Paper›PMID 38458560›Full record

ArticleContemporary clinical trials2024

Healthy food delivery for type 2 diabetes management in rural clinics' patients: A comparative effectiveness randomized controlled trial protocol.

Eliza Short, James P Selig, Holly C Felix, Jacob Painter, Pearl A McElfish, Brett Rowland, Alice S Ammerman, Kelsey Bounds, Joseph Henske, Jonell S Hudson and 3 more

Registry-linked trialOpen access · greenAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04876053 (Home Food Delivery for Diabetes Management in Patients of Rural Clinics), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 95% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04876053 nacompletednot on this map

Home Food Delivery for Diabetes Management in Patients of Rural Clinics

TypeinterventionalSponsorUniversity of ArkansasRan2021 to 2025Enrolled416ConditionsDiabetes Mellitus, Type 2, Diet, HealthyArmsHealthy Food Delivery Intervention, CDCES Consultation Only
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 0 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 4 institutions in 1 country.

Eliza ShortGretchen Swanson Center for Nutrition, 14301 FNB Parkway, Suite 100, Omaha, NE 68154, USA.
James P SeligFay W. Boozman College of Public Health, University of Arkansas for Medical Sciences Northwest, 2708 S. 48(th) St., Springdale, AR 72762, USA.
Holly C FelixFay W. Boozman College of Public Health, University of Arkansas for Medical Sciences, 4301 W. Markham St., Little Rock, AR 72205, USA.
Jacob PainterCollege of Pharmacy, University of Arkansas for Medical Sciences, 4301 W. Markham St., Little Rock, AR 72205, USA.
Pearl A McElfishCollege of Medicine, University of Arkansas for Medical Sciences Northwest, 2708 S. 48(th) St., Springdale, AR 72762, USA. Electronic address: pamcelfish@uams.edu.
Brett RowlandOffice of Community Health and Research, University of Arkansas for Medical Sciences Northwest, 2708 S. 48(th) St., Springdale, AR 72762, USA.
Alice S AmmermanCenter for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, 1700 MLK, Chapel Hill, NC 27599, USA.
Kelsey BoundsOffice of Community Health and Research, University of Arkansas for Medical Sciences Northwest, 2708 S. 48(th) St., Springdale, AR 72762, USA.
Joseph HenskeCollege of Medicine, University of Arkansas for Medical Sciences, 4301 W. Markham St., Little Rock, AR 72205, USA.
Jonell S HudsonCollege of Pharmacy, University of Arkansas for Medical Sciences Northwest, 1125 N. College Ave., Fayetteville, AR 72703, USA.
Ji LiFay W. Boozman College of Public Health, University of Arkansas for Medical Sciences Northwest, 2708 S. 48(th) St., Springdale, AR 72762, USA.
Sean G YoungPeter O'Donnell Jr. School of Public Health, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390, USA.
Christopher R LongGretchen Swanson Center for Nutrition, 14301 FNB Parkway, Suite 100, Omaha, NE 68154, USA.
University of Arkansas for Medical Sciences · USSwanson Center · USThe University of Texas Southwestern Medical Center · USUniversity of North Carolina at Chapel Hill · US

Funding

UNIV OF NORTH CAROLINA CLINICAL NUTRITION RESEARCH UNITP30DK056350 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Venkata Saroja Voruganti · 1999 to 2026
$31.6M
Expanding Translational Research in ArkansasUL1TR003107 · NCATS · UNIV OF ARKANSAS FOR MED SCIS · PI JAMES, LAURA P · 2019 to 2023
$21.6M
Home Food Delivery for Diabetes Management in Patients of Rural ClinicsR01NR019487 · NINR · UNIV OF ARKANSAS FOR MED SCIS · PI MCELFISH, PEARL · 2020 to 2024
$2.5M
NCATS NIH HHS UL1 TR003107NIDDK NIH HHS P30 DK056350NINR NIH HHS R01 NR019487
6 · The paper itself

Abstract

backgroundRural populations experience a higher prevalence of both food insecurity and type 2 diabetes mellitus (T2DM) than metropolitan populations and face many challenges in accessing resources essential to optimal T2DM self-management. This study aims to address these challenges by delivering a T2DM-appropriate food box and recipes directly to rural participants' homes.

methodsThis is a comparative effectiveness randomized controlled trial including 400 English- or Spanish-speaking rural adult participants with T2DM (HbA1c ≥6.5%) experiencing food insecurity. Participants are randomly assigned to a 3-month Healthy Food Delivery Intervention (HFDI) plus one 60-min virtual consultation with a diabetes educator or consultation only. The HFDI includes a weekly food box delivery with recipes. Data are collected at pre-intervention, 3-months (post-intervention), 9-months, and 15-months. The primary outcome is change in HbA1c, with secondary measures including diet quality (Healthy Eating Index-2015, calculated from one 24-h dietary recall at each data collection time point), cardio-metabolic risk factors (i.e., blood pressure, lipids, body mass index, glucose), and patient-centered outcomes (e.g., T2DM self-efficacy, T2DM-related distress). Process evaluation data (e.g., successful food box deliveries, diabetes educator consultation attendance, intervention satisfaction) are collected during and post-intervention (3-months). A cost-effectiveness analysis based on traditional cost per quality-adjusted life year gain thresholds will be conducted to estimate the incremental cost-effectiveness between HFDI plus consultation and consultation alone.

conclusionFindings from this study will provide evidence regarding the effectiveness of an intervention that promotes participant adherence and improves access to healthy food. CLINICAL

trial registrationNCT04876053.

Indexed as

Diabetes Mellitus, Type 2Diet, HealthyGlycated HemoglobinRural PopulationAdultBody Mass IndexComparative Effectiveness ResearchCost-Benefit AnalysisFemaleFood SupplyHumansMalePatient Education as TopicRandomized Controlled Trials as TopicSelf-ManagementGlycated HemoglobinClinical trial protocolFood assistanceFood securityRandomized controlled trialSocial determinants of healthType 2 diabetes mellitus

Identifiers

PMID38458560
PMCPMC11065573
OpenAlexW4392503967

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.