Healthy Food Delivery for Type 2 Diabetes Management in Rural Clinics' Patients: A Comparative Effectiveness Randomized Controlled Trial Protocol

Overview

Journal Contemp Clin Trials

Publisher Elsevier

Date 2024 Mar 8

PMID 38458560

Authors

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

Ji Li

Sean G Young

Christopher R Long

Affiliations

Soon will be listed here.

Abstract

Background: Rural 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.

Methods: This 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.

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

Clinical Trial Registration: NCT04876053.

References

Palar K, Napoles T, Hufstedler L, Seligman H, Hecht F, Madsen K . Comprehensive and Medically Appropriate Food Support Is Associated with Improved HIV and Diabetes Health. J Urban Health. 2017; 94(1):87-99. PMC: 5359179. DOI: 10.1007/s11524-016-0129-7. View

Ermakov I, Gellermann W . Dermal carotenoid measurements via pressure mediated reflection spectroscopy. J Biophotonics. 2012; 5(7):559-70. DOI: 10.1002/jbio.201100122. View

McElfish P, Liston R, Smith V, Norris A, Weaver J, Dickson S . Rural Research Network to engage rural and minority community members in translational research. J Clin Transl Res. 2023; 9(2):115-122. PMC: 10171320. View

Leung C, Epel E, Ritchie L, Crawford P, Laraia B . Food insecurity is inversely associated with diet quality of lower-income adults. J Acad Nutr Diet. 2014; 114(12):1943-53.e2. DOI: 10.1016/j.jand.2014.06.353. View

Gao Y, Yang A, Zurbau A, Gucciardi E . The Effect of Food is Medicine Interventions on Diabetes-related Health Outcomes Among Low-income and Food-insecure Individuals: A Systematic Review and Meta-analysis. Can J Diabetes. 2022; 47(2):143-152. DOI: 10.1016/j.jcjd.2022.11.001. View

Seligman H, Smith M, Rosenmoss S, Marshall M, Waxman E . Comprehensive Diabetes Self-Management Support From Food Banks: A Randomized Controlled Trial. Am J Public Health. 2018; 108(9):1227-1234. PMC: 6085038. DOI: 10.2105/AJPH.2018.304528. View

Nguyen B, Shuval K, Bertmann F, Yaroch A . The Supplemental Nutrition Assistance Program, Food Insecurity, Dietary Quality, and Obesity Among U.S. Adults. Am J Public Health. 2015; 105(7):1453-9. PMC: 4463405. DOI: 10.2105/AJPH.2015.302580. View

Faul F, Erdfelder E, Buchner A, Lang A . Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009; 41(4):1149-60. DOI: 10.3758/BRM.41.4.1149. View

Clark M, Utz S . Social determinants of type 2 diabetes and health in the United States. World J Diabetes. 2014; 5(3):296-304. PMC: 4058734. DOI: 10.4239/wjd.v5.i3.296. View

10.

Jilcott Pitts S, Johnson N, Wu Q, Firnhaber G, Preet Kaur A, Obasohan J . A meta-analysis of studies examining associations between resonance Raman spectroscopy-assessed skin carotenoids and plasma carotenoids among adults and children. Nutr Rev. 2021; 80(2):230-241. PMC: 8754254. DOI: 10.1093/nutrit/nuab016. View

11.

Little R, Rohlfing C, Sacks D . Status of hemoglobin A1c measurement and goals for improvement: from chaos to order for improving diabetes care. Clin Chem. 2010; 57(2):205-14. DOI: 10.1373/clinchem.2010.148841. View

12.

Ingram D, Franco S . 2013 NCHS Urban-Rural Classification Scheme for Counties. Vital Health Stat 2. 2014; (166):1-73. View

13.

Toobert D, Hampson S, Glasgow R . The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000; 23(7):943-50. DOI: 10.2337/diacare.23.7.943. View

14.

Rodriguez K, Ryan D, Dickinson J, Phan V . Improving Quality Outcomes: The Value of Diabetes Care and Education Specialists. Clin Diabetes. 2022; 40(3):356-365. PMC: 9331628. DOI: 10.2337/cd21-0089. View

15.

Nathan D, Buse J, Davidson M, Ferrannini E, Holman R, Sherwin R . Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2008; 32(1):193-203. PMC: 2606813. DOI: 10.2337/dc08-9025. View

16.

Long C, Stewart M, McElfish P . Health research participants are not receiving research results: a collaborative solution is needed. Trials. 2017; 18(1):449. PMC: 5625845. DOI: 10.1186/s13063-017-2200-4. View

17.

Barton K, Wrieden W, Anderson A . Validity and reliability of a short questionnaire for assessing the impact of cooking skills interventions. J Hum Nutr Diet. 2011; 24(6):588-95. DOI: 10.1111/j.1365-277X.2011.01180.x. View

18.

Berkowitz S, Karter A, Corbie-Smith G, Seligman H, Ackroyd S, Barnard L . Food Insecurity, Food "Deserts," and Glycemic Control in Patients With Diabetes: A Longitudinal Analysis. Diabetes Care. 2018; 41(6):1188-1195. PMC: 5961388. DOI: 10.2337/dc17-1981. View

19.

Ermakov I, Ermakova M, Sharifzadeh M, Gorusupudi A, Farnsworth K, Bernstein P . Optical assessment of skin carotenoid status as a biomarker of vegetable and fruit intake. Arch Biochem Biophys. 2018; 646:46-54. PMC: 6370053. DOI: 10.1016/j.abb.2018.03.033. View

20.

Janssen M, Pickard A, Golicki D, Gudex C, Niewada M, Scalone L . Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2012; 22(7):1717-27. PMC: 3764313. DOI: 10.1007/s11136-012-0322-4. View