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

Contemp Clin Trials. 2024 May:140:107491. doi: 10.1016/j.cct.2024.107491. Epub 2024 Mar 6.

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.

Keywords: Clinical trial protocol; Food assistance; Food security; Randomized controlled trial; Social determinants of health; Type 2 diabetes mellitus.

Publication types

  • Clinical Trial Protocol
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Body Mass Index
  • Comparative Effectiveness Research
  • Cost-Benefit Analysis
  • Diabetes Mellitus, Type 2* / therapy
  • Diet, Healthy* / methods
  • Female
  • Food Supply
  • Glycated Hemoglobin* / analysis
  • Humans
  • Male
  • Patient Education as Topic / methods
  • Patient Education as Topic / organization & administration
  • Rural Population*
  • Self-Management / methods

Substances

  • Glycated Hemoglobin

Associated data

  • ClinicalTrials.gov/NCT04876053