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Healthy food delivery for type 2 diabetes management in rural clinics' patients: A comparative effectiveness randomized controlled trial protocol.
- Source :
-
Contemporary clinical trials [Contemp Clin Trials] 2024 May; Vol. 140, pp. 107491. Date of Electronic Publication: 2024 Mar 06. - Publication Year :
- 2024
-
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.<br />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.<br />Conclusion: Findings from this study will provide evidence regarding the effectiveness of an intervention that promotes participant adherence and improves access to healthy food.<br />Clinical Trial Registration: NCT04876053.<br />Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.<br /> (Copyright © 2024 Elsevier Inc. All rights reserved.)
- Subjects :
- Adult
Female
Humans
Male
Body Mass Index
Comparative Effectiveness Research
Cost-Benefit Analysis
Food Supply
Patient Education as Topic methods
Patient Education as Topic organization & administration
Self-Management methods
Randomized Controlled Trials as Topic
Diabetes Mellitus, Type 2 therapy
Diet, Healthy methods
Glycated Hemoglobin analysis
Rural Population
Subjects
Details
- Language :
- English
- ISSN :
- 1559-2030
- Volume :
- 140
- Database :
- MEDLINE
- Journal :
- Contemporary clinical trials
- Publication Type :
- Academic Journal
- Accession number :
- 38458560
- Full Text :
- https://doi.org/10.1016/j.cct.2024.107491